{"success":true,"data":{"pressRelease":{"id":"150638","rtpr_id":"nBw47PYt0a-20260923","ticker":"TVTX","exchange":"NASDAQ","all_tickers":["TVTX"],"title":"Travere Therapeutics Receives Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Patent Application Directed to Certain Methods of Using FILSPARI® (sparsentan) in Focal Segmental Glomerulosclerosis","author":"Business Wire","published_at":"2026-09-23T11:00:00.540Z","article_body":"Travere Therapeutics Receives Notice of Allowance from the U.S. Patent and\nTrademark Office for U.S. Patent Application Directed to Certain Methods of\nUsing FILSPARI(®) (sparsentan) in Focal Segmental Glomerulosclerosis\n\nTravere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the United\nStates Patent and Trademark Office (USPTO) issued a Notice of Allowance for\nU.S. Patent Application No. 19/253,120, titled “Biphenyl Sulfonamide\nCompounds for the Treatment of Kidney Diseases or Disorders,” directed to\ncertain methods of using FILSPARI(®) (sparsentan) in focal segmental\nglomerulosclerosis (FSGS). Upon issuance, the patent is expected to provide\nU.S. patent coverage for certain methods of using sparsentan in FSGS into\nOctober 2037.\n\nThe allowed application is expected to issue as a U.S. patent following\npayment of the issue fee and standard USPTO post-allowance processing. Travere\nexpects to submit the issued patent for listing in the FDA’s Approved Drug\nProducts with Therapeutic Equivalence Evaluations (commonly known as the\n“Orange Book”) promptly following grant.\n\nIn August 2026, the USPTO granted a separate U.S. patent to the Company\ncovering certain methods of using sparsentan in IgA nephropathy (IgAN).\n\nAbout Travere Therapeutics\n\nAt Travere Therapeutics, we are in rare for life. We are a biopharmaceutical\ncompany that comes together every day to help patients, families and\ncaregivers of all backgrounds as they navigate life with a rare disease. On\nthis path, we know the need for treatment options is urgent – that is why\nour global team works with the rare disease community to identify, develop and\ndeliver life-changing therapies. In pursuit of this mission, we continuously\nseek to understand the diverse perspectives of rare patients and to\ncourageously forge new paths to make a difference in their lives and provide\nhope – today and tomorrow. For more information, visit travere.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DyPf3J7af38pcoKw0YSeleAZxeBlYdiz1bfiKcdXUxq1Q0YiToi4ovQMRzI4FTF6NqCezCoYAOIF6TxEBI-BUIA%3D%3D&esheet=54608962&newsitemid=20260923592621&lan=en-US&anchor=travere.com&index=1&md5=2d191dd1fab57b95412d888ae9a4fa94)\n.\n\nFILSPARI(®) (sparsentan) U.S. Indication\n\nFILSPARI(®) (sparsentan) is indicated:\n\n\n * To slow kidney function decline in adults with primary immunoglobulin A\nnephropathy (IgAN) who are at risk for disease progression.\n\n * To reduce proteinuria in adult and pediatric patients aged 8 years and older\nwith focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.\n\nIMPORTANT SAFETY INFORMATION\n\nBOXED WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY\n\nBecause of the risk of hepatotoxicity, FILSPARI is available only through a\nrestricted program called the FILSPARI REMS. Under the FILSPARI REMS,\nprescribers, patients and pharmacies must enroll in the program.\n\nHepatotoxicity\n\nSome Endothelin Receptor Antagonists (ERAs) have caused elevations of\naminotransferases, hepatotoxicity, and liver failure. In clinical studies,\nelevations in aminotransferases (ALT or AST) of at least 3-times the Upper\nLimit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated\npatients, including cases confirmed with rechallenge.\n\nMeasure transaminases and bilirubin before initiating treatment and then every\n3 months during treatment. Interrupt treatment and closely monitor patients\nwho develop aminotransferase elevations more than 3x ULN.\n\nFILSPARI should generally be avoided in patients with elevated\naminotransferases (>3x ULN) at baseline because monitoring for\nhepatotoxicity may be more difficult and these patients may be at increased\nrisk for serious hepatotoxicity.\n\nEmbryo-Fetal Toxicity\n\nFILSPARI is contraindicated for use during pregnancy because it may cause\nfetal harm if used by pregnant patients. Therefore, in patients who can become\npregnant, exclude pregnancy prior to initiation of FILSPARI. Advise use of\neffective contraception before the initiation of treatment, during treatment,\nand for two weeks after discontinuation of treatment with FILSPARI. When\npregnancy is detected, discontinue FILSPARI as soon as possible.\n\nContraindications\n\nFILSPARI is contraindicated in patients who are pregnant. Do not coadminister\nFILSPARI with angiotensin receptor blockers (ARBs), ERAs, or aliskiren.\n\nWarnings and Precautions\n\n\n * Hepatotoxicity: Elevations in ALT or AST of at least 3-fold ULN have been\nobserved in up to 3.5% of FILSPARI-treated patients, including cases confirmed\nwith rechallenge. While no concurrent elevations in bilirubin >2-times ULN\nor cases of liver failure were observed in FILSPARI-treated patients in\nclinical trials, some ERAs have caused elevations of aminotransferases,\nhepatotoxicity, and liver failure. To reduce the risk of potential serious\nhepatotoxicity, measure serum aminotransferase levels and total bilirubin\nprior to initiation of treatment and then every 3 months during treatment.\n\n\n\nAdvise patients with symptoms suggesting hepatotoxicity (nausea, vomiting,\nright upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or\nitching) to immediately stop treatment with FILSPARI and seek medical\nattention. If aminotransferase levels are abnormal at any time during\ntreatment, interrupt FILSPARI and monitor as recommended.\n\n\n\nConsider re-initiation of FILSPARI only when hepatic enzyme levels and\nbilirubin return to pretreatment values and only in patients who have not\nexperienced clinical symptoms of hepatotoxicity. Avoid initiation of FILSPARI\nin patients with elevated aminotransferases (>3x ULN) because monitoring\nhepatotoxicity in these patients may be more difficult and these patients may\nbe at increased risk for serious hepatotoxicity.\n\n\n * FILSPARI REMS: Due to the risk of hepatotoxicity, FILSPARI is available only\nthrough a restricted program called the FILSPARI REMS. Prescribers, patients,\nand pharmacies must be enrolled in the REMS program and comply with all\nrequirements (\nwww.filsparirems.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.filsparirems.com&esheet=54608962&newsitemid=20260923592621&lan=en-US&anchor=www.filsparirems.com&index=2&md5=b0ef1af8e7160edd6ca8a49798951f4d)\n\n).\n\n * Embryo-Fetal Toxicity: Based on data from animal reproduction studies,\nFILSPARI may cause fetal harm when administered to a pregnant patient and is\ncontraindicated during pregnancy. The available human data for ERAs do not\nestablish the presence or absence of fetal harm related to the use of\nFILSPARI. Counsel patients who can become pregnant of the potential risk to a\nfetus. Exclude pregnancy before initiating treatment with FILSPARI. Advise\npatients who can become pregnant to use effective contraception prior to\ninitiation of treatment, during treatment, and for two weeks after\ndiscontinuation of treatment with FILSPARI. Advise pre-pubertal females and/or\ntheir guardian(s) of the fetal risk and the need to use effective\ncontraception once they reach reproductive potential. When pregnancy is\ndetected, discontinue FILSPARI as soon as possible.\n\n * Hypotension: Hypotension has been observed in patients treated with ARBs and\nERAs and was observed in FILSPARI clinical studies. There was a greater\nincidence of hypotension-associated adverse events, some serious, including\ndizziness, in patients treated with FILSPARI compared to irbesartan. In\npatients at risk for hypotension, consider eliminating or adjusting other\nantihypertensive medications and maintaining appropriate volume status. If\nhypotension develops, despite elimination or reduction of other\nantihypertensive medications, consider a dose reduction or dose interruption\nof FILSPARI. A transient hypotensive response is not a contraindication to\nfurther dosing of FILSPARI, which can be given once blood pressure has\nstabilized.\n\n * Acute Kidney Injury: Monitor kidney function periodically. Drugs that inhibit\nthe renin-angiotensin system (RAS) can cause kidney injury. Patients whose\nkidney function may depend in part on the activity of the RAS (e.g., patients\nwith renal artery stenosis, chronic kidney disease, severe congestive heart\nfailure, or volume depletion) may be at particular risk of developing acute\nkidney injury on FILSPARI. Consider withholding or discontinuing therapy in\npatients who develop a clinically significant decrease in kidney function\nwhile on FILSPARI.\n\n * Hyperkalemia: Monitor serum potassium periodically and treat appropriately.\nPatients with advanced kidney disease, taking concomitant potassium-increasing\ndrugs (e.g., potassium supplements, potassium-sparing diuretics), or using\npotassium-containing salt substitutes are at increased risk for developing\nhyperkalemia. Dosage reduction or discontinuation of FILSPARI may be required.\n\n * Fluid Retention: Fluid retention may occur with ERAs and has been observed in\nclinical studies with FILSPARI. FILSPARI has not been evaluated in patients\nwith heart failure. If clinically significant fluid retention develops,\nevaluate the patient to determine the cause and the potential need to initiate\nor modify the dose of diuretic treatment then consider modifying the dose of\nFILSPARI.\n\nAdverse Reactions\n\n\n * IgAN patients receiving FILSPARI: The most common adverse reactions (≥5%)\nare hyperkalemia, hypotension (including orthostatic hypotension), peripheral\nedema, dizziness, anemia, and acute kidney injury.\n\n * FSGS patients receiving FILSPARI: The most common adverse reactions (≥5%)\nare peripheral edema, hypotension (including orthostatic hypotension),\nhyperkalemia, dizziness, and anemia.\n\nDrug Interactions\n\n\n * Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister\nFILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension,\nsyncope, hyperkalemia, and changes in renal function (including acute renal\nfailure).\n\n * Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with\nstrong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided,\ninterrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider\ndose titration. Monitor blood pressure, serum potassium, edema, and kidney\nfunction regularly when used concomitantly with moderate CYP3A inhibitors.\nConcomitant use with a strong CYP3A inhibitor increases sparsentan exposure\nwhich may increase the risk of FILSPARI adverse reactions.\n\n * Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer.\nConcomitant use with a strong CYP3A inducer decreases sparsentan exposure\nwhich may reduce FILSPARI efficacy.\n\n * Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective\nCyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal\nfunction with concomitant use with NSAIDs (including selective COX-2\ninhibitors). In patients with volume depletion (including those on diuretic\ntherapy) or with impaired kidney function, concomitant use of NSAIDs\n(including selective COX-2 inhibitors) with drugs that antagonize the\nangiotensin II receptor may result in deterioration of kidney function,\nincluding possible kidney failure. These effects are usually reversible.\n\n * CYP2B6, 2C9, and 2C19 Substrates: Monitor for efficacy of concurrently\nadministered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment\nin accordance with the Prescribing Information. Sparsentan is a weak inducer\nof CYP2B6 and 2C9, and a moderate inducer of 2C19. Sparsentan decreases\nexposure of these substrates, which may reduce efficacy related to these\nsubstrates.\n\n * P-gp Substrates: Monitor for adverse reactions and consider dose reduction of\nP-gp substrates with narrow therapeutic indices when co-administered with\nFILSPARI. FILSPARI is a weak P-gp inhibitor and may increase plasma\nconcentrations of P-gp substrate drugs.\n\n * Agents Increasing Serum Potassium: Monitor serum potassium frequently in\npatients treated with FILSPARI and other agents that increase serum potassium.\nConcomitant use of FILSPARI with potassium-sparing diuretics, potassium\nsupplements, potassium-containing salt substitutes, or other drugs that raise\nserum potassium levels may result in hyperkalemia.\n\nPlease see the full Prescribing Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftravere.com%2Ffilspari-prescribing-information%2F&esheet=54608962&newsitemid=20260923592621&lan=en-US&anchor=Prescribing+Information&index=3&md5=0d42cc55cd51f8e60b093f70e084291c)\n, including BOXED WARNING, for additional Important Safety Information.\n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” as that term is\ndefined in the Private Securities Litigation Reform Act of 1995. Without\nlimiting the foregoing, these statements are often identified by the words\n“on-track,” “positioned,” “look forward to,” “will,”\n“would,” “may,” “might,” “believes,” “anticipates,”\n“plans,” “expects,” “intends,” “potential,” or similar\nexpressions. In addition, expressions of strategies, intentions or plans are\nalso forward-looking statements. Such forward-looking statements include, but\nare not limited to, references to: statements regarding the expected issuance\nof a U.S. patent from U.S. Patent Application No. 19/253,120; the expected\ntiming of issuance; the expected scope and duration of patent coverage from\nany issued patent; the potential for any issued patent to provide U.S. patent\ncoverage for certain methods of using FILSPARI in FSGS into October 2037;\nTravere’s expectation to submit the issued patent for listing in the Orange\nBook promptly following issuance; and Travere’s expectations regarding its\nintellectual property portfolio for FILSPARI. Such forward-looking statements\nare based on current expectations and involve inherent risks and\nuncertainties, including factors that could delay, divert or change any of\nthem, and could cause actual outcomes and results to differ materially from\ncurrent expectations. No forward-looking statement can be guaranteed. Among\nthe factors that could cause actual results to differ materially from those\nindicated in the forward-looking statements are risks and uncertainties\nrelated to the issuance, timing, scope, validity, enforceability and listing\nof any patent issuing from U.S. Patent Application No. 19/253,120. The Company\nalso faces risks and uncertainties related to its business and finances in\ngeneral, the success of its commercial products, risks and uncertainties\nassociated with its preclinical and clinical stage pipeline, risks and\nuncertainties associated with the regulatory review and approval process,\nrisks and uncertainties associated with enrollment of clinical trials for rare\ndiseases, and risks that ongoing or planned clinical trials may not succeed or\nmay be delayed for safety, regulatory or other reasons. Specifically, the\nCompany faces risks associated with the commercial launch of FILSPARI in FSGS\nand the ongoing commercialization in IgAN, the timing and potential outcome of\nits and its partners’ clinical studies, market acceptance of its commercial\nproducts including efficacy, safety, price, reimbursement, and benefit over\ncompeting therapies, risks related to the challenges of manufacturing\nscale-up, risks associated with the successful development and execution of\ncommercial strategies for such products, including FILSPARI, and risks and\nuncertainties related to the current administration, including but not limited\nto risks and uncertainties related to tariffs and the funding, staffing and\nprioritization of resources at government agencies including the FDA. The\nCompany also faces the risk that it will be unable to raise additional funding\nthat may be required to complete development of any or all of its product\ncandidates, including as a result of macroeconomic conditions; risks relating\nto the Company’s dependence on contractors for clinical drug supply and\ncommercial manufacturing; uncertainties relating to patent protection and\nexclusivity periods and intellectual property rights of third parties; risks\nassociated with regulatory interactions; and risks and uncertainties relating\nto competitive products, including current and potential future generic\ncompetition with certain of the Company’s products, including potential ANDA\nfilings or patent challenges, and technological changes that may limit demand\nfor the Company’s products. The Company also faces additional risks\nassociated with global and macroeconomic conditions, including health\nepidemics and pandemics, including risks related to potential disruptions to\nclinical trials, commercialization activity, supply chain, and manufacturing\noperations. You are cautioned not to place undue reliance on these\nforward-looking statements as there are important factors that could cause\nactual results to differ materially from those in forward-looking statements,\nmany of which are beyond our control. The Company undertakes no obligation to\npublicly update any forward-looking statement, whether as a result of new\ninformation, future events, or otherwise. Investors are referred to the full\ndiscussion of risks and uncertainties, including under the heading “Risk\nFactors”, as included in the Company’s most recent Form 10-K, Form 10-Q\nand other filings with the Securities and Exchange Commission.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260923592621/en/\n(https://www.businesswire.com/news/home/20260923592621/en/)\n\nInvestors:\n\n888-969-7879\n\nir@travere.com (mailto:ir@travere.com)\n\nMedia:\n\n888-969-7879\n\nmediarelations@travere.com (mailto:mediarelations@travere.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw47PYt0a-20260923","title":"Travere Therapeutics Receives Notice of Allowance from the U.S. Patent and Trademark Office for U.S. Patent Application Directed to Certain Methods of Using FILSPARI® (sparsentan) in Focal Segmental Glomerulosclerosis","author":"Business Wire","ticker":"TVTX","created":"2026-09-23T11:00:00.540Z","tickers":["TVTX"],"exchange":"NASDAQ","article_body":"Travere Therapeutics Receives Notice of Allowance from the U.S. Patent and\nTrademark Office for U.S. Patent Application Directed to Certain Methods of\nUsing FILSPARI(®) (sparsentan) in Focal Segmental Glomerulosclerosis\n\nTravere Therapeutics, Inc. (Nasdaq: TVTX) today announced that the United\nStates Patent and Trademark Office (USPTO) issued a Notice of Allowance for\nU.S. Patent Application No. 19/253,120, titled “Biphenyl Sulfonamide\nCompounds for the Treatment of Kidney Diseases or Disorders,” directed to\ncertain methods of using FILSPARI(®) (sparsentan) in focal segmental\nglomerulosclerosis (FSGS). Upon issuance, the patent is expected to provide\nU.S. patent coverage for certain methods of using sparsentan in FSGS into\nOctober 2037.\n\nThe allowed application is expected to issue as a U.S. patent following\npayment of the issue fee and standard USPTO post-allowance processing. Travere\nexpects to submit the issued patent for listing in the FDA’s Approved Drug\nProducts with Therapeutic Equivalence Evaluations (commonly known as the\n“Orange Book”) promptly following grant.\n\nIn August 2026, the USPTO granted a separate U.S. patent to the Company\ncovering certain methods of using sparsentan in IgA nephropathy (IgAN).\n\nAbout Travere Therapeutics\n\nAt Travere Therapeutics, we are in rare for life. We are a biopharmaceutical\ncompany that comes together every day to help patients, families and\ncaregivers of all backgrounds as they navigate life with a rare disease. On\nthis path, we know the need for treatment options is urgent – that is why\nour global team works with the rare disease community to identify, develop and\ndeliver life-changing therapies. In pursuit of this mission, we continuously\nseek to understand the diverse perspectives of rare patients and to\ncourageously forge new paths to make a difference in their lives and provide\nhope – today and tomorrow. For more information, visit travere.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DyPf3J7af38pcoKw0YSeleAZxeBlYdiz1bfiKcdXUxq1Q0YiToi4ovQMRzI4FTF6NqCezCoYAOIF6TxEBI-BUIA%3D%3D&esheet=54608962&newsitemid=20260923592621&lan=en-US&anchor=travere.com&index=1&md5=2d191dd1fab57b95412d888ae9a4fa94)\n.\n\nFILSPARI(®) (sparsentan) U.S. Indication\n\nFILSPARI(®) (sparsentan) is indicated:\n\n\n * To slow kidney function decline in adults with primary immunoglobulin A\nnephropathy (IgAN) who are at risk for disease progression.\n\n * To reduce proteinuria in adult and pediatric patients aged 8 years and older\nwith focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.\n\nIMPORTANT SAFETY INFORMATION\n\nBOXED WARNING: HEPATOTOXICITY AND EMBRYO-FETAL TOXICITY\n\nBecause of the risk of hepatotoxicity, FILSPARI is available only through a\nrestricted program called the FILSPARI REMS. Under the FILSPARI REMS,\nprescribers, patients and pharmacies must enroll in the program.\n\nHepatotoxicity\n\nSome Endothelin Receptor Antagonists (ERAs) have caused elevations of\naminotransferases, hepatotoxicity, and liver failure. In clinical studies,\nelevations in aminotransferases (ALT or AST) of at least 3-times the Upper\nLimit of Normal (ULN) have been observed in up to 3.5% of FILSPARI-treated\npatients, including cases confirmed with rechallenge.\n\nMeasure transaminases and bilirubin before initiating treatment and then every\n3 months during treatment. Interrupt treatment and closely monitor patients\nwho develop aminotransferase elevations more than 3x ULN.\n\nFILSPARI should generally be avoided in patients with elevated\naminotransferases (>3x ULN) at baseline because monitoring for\nhepatotoxicity may be more difficult and these patients may be at increased\nrisk for serious hepatotoxicity.\n\nEmbryo-Fetal Toxicity\n\nFILSPARI is contraindicated for use during pregnancy because it may cause\nfetal harm if used by pregnant patients. Therefore, in patients who can become\npregnant, exclude pregnancy prior to initiation of FILSPARI. Advise use of\neffective contraception before the initiation of treatment, during treatment,\nand for two weeks after discontinuation of treatment with FILSPARI. When\npregnancy is detected, discontinue FILSPARI as soon as possible.\n\nContraindications\n\nFILSPARI is contraindicated in patients who are pregnant. Do not coadminister\nFILSPARI with angiotensin receptor blockers (ARBs), ERAs, or aliskiren.\n\nWarnings and Precautions\n\n\n * Hepatotoxicity: Elevations in ALT or AST of at least 3-fold ULN have been\nobserved in up to 3.5% of FILSPARI-treated patients, including cases confirmed\nwith rechallenge. While no concurrent elevations in bilirubin >2-times ULN\nor cases of liver failure were observed in FILSPARI-treated patients in\nclinical trials, some ERAs have caused elevations of aminotransferases,\nhepatotoxicity, and liver failure. To reduce the risk of potential serious\nhepatotoxicity, measure serum aminotransferase levels and total bilirubin\nprior to initiation of treatment and then every 3 months during treatment.\n\n\n\nAdvise patients with symptoms suggesting hepatotoxicity (nausea, vomiting,\nright upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or\nitching) to immediately stop treatment with FILSPARI and seek medical\nattention. If aminotransferase levels are abnormal at any time during\ntreatment, interrupt FILSPARI and monitor as recommended.\n\n\n\nConsider re-initiation of FILSPARI only when hepatic enzyme levels and\nbilirubin return to pretreatment values and only in patients who have not\nexperienced clinical symptoms of hepatotoxicity. Avoid initiation of FILSPARI\nin patients with elevated aminotransferases (>3x ULN) because monitoring\nhepatotoxicity in these patients may be more difficult and these patients may\nbe at increased risk for serious hepatotoxicity.\n\n\n * FILSPARI REMS: Due to the risk of hepatotoxicity, FILSPARI is available only\nthrough a restricted program called the FILSPARI REMS. Prescribers, patients,\nand pharmacies must be enrolled in the REMS program and comply with all\nrequirements (\nwww.filsparirems.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.filsparirems.com&esheet=54608962&newsitemid=20260923592621&lan=en-US&anchor=www.filsparirems.com&index=2&md5=b0ef1af8e7160edd6ca8a49798951f4d)\n\n).\n\n * Embryo-Fetal Toxicity: Based on data from animal reproduction studies,\nFILSPARI may cause fetal harm when administered to a pregnant patient and is\ncontraindicated during pregnancy. The available human data for ERAs do not\nestablish the presence or absence of fetal harm related to the use of\nFILSPARI. Counsel patients who can become pregnant of the potential risk to a\nfetus. Exclude pregnancy before initiating treatment with FILSPARI. Advise\npatients who can become pregnant to use effective contraception prior to\ninitiation of treatment, during treatment, and for two weeks after\ndiscontinuation of treatment with FILSPARI. Advise pre-pubertal females and/or\ntheir guardian(s) of the fetal risk and the need to use effective\ncontraception once they reach reproductive potential. When pregnancy is\ndetected, discontinue FILSPARI as soon as possible.\n\n * Hypotension: Hypotension has been observed in patients treated with ARBs and\nERAs and was observed in FILSPARI clinical studies. There was a greater\nincidence of hypotension-associated adverse events, some serious, including\ndizziness, in patients treated with FILSPARI compared to irbesartan. In\npatients at risk for hypotension, consider eliminating or adjusting other\nantihypertensive medications and maintaining appropriate volume status. If\nhypotension develops, despite elimination or reduction of other\nantihypertensive medications, consider a dose reduction or dose interruption\nof FILSPARI. A transient hypotensive response is not a contraindication to\nfurther dosing of FILSPARI, which can be given once blood pressure has\nstabilized.\n\n * Acute Kidney Injury: Monitor kidney function periodically. Drugs that inhibit\nthe renin-angiotensin system (RAS) can cause kidney injury. Patients whose\nkidney function may depend in part on the activity of the RAS (e.g., patients\nwith renal artery stenosis, chronic kidney disease, severe congestive heart\nfailure, or volume depletion) may be at particular risk of developing acute\nkidney injury on FILSPARI. Consider withholding or discontinuing therapy in\npatients who develop a clinically significant decrease in kidney function\nwhile on FILSPARI.\n\n * Hyperkalemia: Monitor serum potassium periodically and treat appropriately.\nPatients with advanced kidney disease, taking concomitant potassium-increasing\ndrugs (e.g., potassium supplements, potassium-sparing diuretics), or using\npotassium-containing salt substitutes are at increased risk for developing\nhyperkalemia. Dosage reduction or discontinuation of FILSPARI may be required.\n\n * Fluid Retention: Fluid retention may occur with ERAs and has been observed in\nclinical studies with FILSPARI. FILSPARI has not been evaluated in patients\nwith heart failure. If clinically significant fluid retention develops,\nevaluate the patient to determine the cause and the potential need to initiate\nor modify the dose of diuretic treatment then consider modifying the dose of\nFILSPARI.\n\nAdverse Reactions\n\n\n * IgAN patients receiving FILSPARI: The most common adverse reactions (≥5%)\nare hyperkalemia, hypotension (including orthostatic hypotension), peripheral\nedema, dizziness, anemia, and acute kidney injury.\n\n * FSGS patients receiving FILSPARI: The most common adverse reactions (≥5%)\nare peripheral edema, hypotension (including orthostatic hypotension),\nhyperkalemia, dizziness, and anemia.\n\nDrug Interactions\n\n\n * Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister\nFILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension,\nsyncope, hyperkalemia, and changes in renal function (including acute renal\nfailure).\n\n * Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with\nstrong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided,\ninterrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider\ndose titration. Monitor blood pressure, serum potassium, edema, and kidney\nfunction regularly when used concomitantly with moderate CYP3A inhibitors.\nConcomitant use with a strong CYP3A inhibitor increases sparsentan exposure\nwhich may increase the risk of FILSPARI adverse reactions.\n\n * Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer.\nConcomitant use with a strong CYP3A inducer decreases sparsentan exposure\nwhich may reduce FILSPARI efficacy.\n\n * Non-Steroidal Anti-Inflammatory Agents (NSAIDs), Including Selective\nCyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal\nfunction with concomitant use with NSAIDs (including selective COX-2\ninhibitors). In patients with volume depletion (including those on diuretic\ntherapy) or with impaired kidney function, concomitant use of NSAIDs\n(including selective COX-2 inhibitors) with drugs that antagonize the\nangiotensin II receptor may result in deterioration of kidney function,\nincluding possible kidney failure. These effects are usually reversible.\n\n * CYP2B6, 2C9, and 2C19 Substrates: Monitor for efficacy of concurrently\nadministered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment\nin accordance with the Prescribing Information. Sparsentan is a weak inducer\nof CYP2B6 and 2C9, and a moderate inducer of 2C19. Sparsentan decreases\nexposure of these substrates, which may reduce efficacy related to these\nsubstrates.\n\n * P-gp Substrates: Monitor for adverse reactions and consider dose reduction of\nP-gp substrates with narrow therapeutic indices when co-administered with\nFILSPARI. FILSPARI is a weak P-gp inhibitor and may increase plasma\nconcentrations of P-gp substrate drugs.\n\n * Agents Increasing Serum Potassium: Monitor serum potassium frequently in\npatients treated with FILSPARI and other agents that increase serum potassium.\nConcomitant use of FILSPARI with potassium-sparing diuretics, potassium\nsupplements, potassium-containing salt substitutes, or other drugs that raise\nserum potassium levels may result in hyperkalemia.\n\nPlease see the full Prescribing Information\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftravere.com%2Ffilspari-prescribing-information%2F&esheet=54608962&newsitemid=20260923592621&lan=en-US&anchor=Prescribing+Information&index=3&md5=0d42cc55cd51f8e60b093f70e084291c)\n, including BOXED WARNING, for additional Important Safety Information.\n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” as that term is\ndefined in the Private Securities Litigation Reform Act of 1995. Without\nlimiting the foregoing, these statements are often identified by the words\n“on-track,” “positioned,” “look forward to,” “will,”\n“would,” “may,” “might,” “believes,” “anticipates,”\n“plans,” “expects,” “intends,” “potential,” or similar\nexpressions. In addition, expressions of strategies, intentions or plans are\nalso forward-looking statements. Such forward-looking statements include, but\nare not limited to, references to: statements regarding the expected issuance\nof a U.S. patent from U.S. Patent Application No. 19/253,120; the expected\ntiming of issuance; the expected scope and duration of patent coverage from\nany issued patent; the potential for any issued patent to provide U.S. patent\ncoverage for certain methods of using FILSPARI in FSGS into October 2037;\nTravere’s expectation to submit the issued patent for listing in the Orange\nBook promptly following issuance; and Travere’s expectations regarding its\nintellectual property portfolio for FILSPARI. Such forward-looking statements\nare based on current expectations and involve inherent risks and\nuncertainties, including factors that could delay, divert or change any of\nthem, and could cause actual outcomes and results to differ materially from\ncurrent expectations. No forward-looking statement can be guaranteed. Among\nthe factors that could cause actual results to differ materially from those\nindicated in the forward-looking statements are risks and uncertainties\nrelated to the issuance, timing, scope, validity, enforceability and listing\nof any patent issuing from U.S. Patent Application No. 19/253,120. The Company\nalso faces risks and uncertainties related to its business and finances in\ngeneral, the success of its commercial products, risks and uncertainties\nassociated with its preclinical and clinical stage pipeline, risks and\nuncertainties associated with the regulatory review and approval process,\nrisks and uncertainties associated with enrollment of clinical trials for rare\ndiseases, and risks that ongoing or planned clinical trials may not succeed or\nmay be delayed for safety, regulatory or other reasons. Specifically, the\nCompany faces risks associated with the commercial launch of FILSPARI in FSGS\nand the ongoing commercialization in IgAN, the timing and potential outcome of\nits and its partners’ clinical studies, market acceptance of its commercial\nproducts including efficacy, safety, price, reimbursement, and benefit over\ncompeting therapies, risks related to the challenges of manufacturing\nscale-up, risks associated with the successful development and execution of\ncommercial strategies for such products, including FILSPARI, and risks and\nuncertainties related to the current administration, including but not limited\nto risks and uncertainties related to tariffs and the funding, staffing and\nprioritization of resources at government agencies including the FDA. The\nCompany also faces the risk that it will be unable to raise additional funding\nthat may be required to complete development of any or all of its product\ncandidates, including as a result of macroeconomic conditions; risks relating\nto the Company’s dependence on contractors for clinical drug supply and\ncommercial manufacturing; uncertainties relating to patent protection and\nexclusivity periods and intellectual property rights of third parties; risks\nassociated with regulatory interactions; and risks and uncertainties relating\nto competitive products, including current and potential future generic\ncompetition with certain of the Company’s products, including potential ANDA\nfilings or patent challenges, and technological changes that may limit demand\nfor the Company’s products. The Company also faces additional risks\nassociated with global and macroeconomic conditions, including health\nepidemics and pandemics, including risks related to potential disruptions to\nclinical trials, commercialization activity, supply chain, and manufacturing\noperations. You are cautioned not to place undue reliance on these\nforward-looking statements as there are important factors that could cause\nactual results to differ materially from those in forward-looking statements,\nmany of which are beyond our control. The Company undertakes no obligation to\npublicly update any forward-looking statement, whether as a result of new\ninformation, future events, or otherwise. Investors are referred to the full\ndiscussion of risks and uncertainties, including under the heading “Risk\nFactors”, as included in the Company’s most recent Form 10-K, Form 10-Q\nand other filings with the Securities and Exchange Commission.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260923592621/en/\n(https://www.businesswire.com/news/home/20260923592621/en/)\n\nInvestors:\n\n888-969-7879\n\nir@travere.com (mailto:ir@travere.com)\n\nMedia:\n\n888-969-7879\n\nmediarelations@travere.com (mailto:mediarelations@travere.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-09-23T11:00:00.754571088Z","server_sent_at_ms":1790161200754},"received_at":"2026-09-23T11:00:00.902Z","source_url":"https://www.businesswire.com/news/home/20260923592621/en/"},"analysis":{"id":"139434","press_release_id":"150638","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"operations_update","narrative":"Travere Therapeutics received a Notice of Allowance from the USPTO for a U.S. patent application covering certain methods of using FILSPARI (sparsentan) in focal segmental glomerulosclerosis.\n\nUpon issuance, the patent is expected to provide U.S. coverage for these FSGS methods into October 2037, and Travere plans to list it in the FDA Orange Book promptly after grant.\n\nThe allowance complements a separate U.S. patent granted in August 2026 covering sparsentan methods in IgA nephropathy, extending the drug's intellectual-property moat.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"FILSPARI exclusivity runway extended to October 2037 via FSGS method-of-use patent allowance with planned Orange Book listing."},"keyFigures":{"drugName":"FILSPARI (sparsentan)","customDimensions":{"patent_coverage_through":"October 2037","patent_application_number":"19/253,120"}},"namedEntities":{"people":[],"products":["FILSPARI","sparsentan"],"companies":[{"name":"Travere Therapeutics, Inc.","ticker":"TVTX","relationship":"filer"},{"name":"U.S. Patent and Trademark Office (USPTO)","relationship":"regulator"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Patent allowance extends FILSPARI FSGS method-of-use coverage into October 2037 with planned Orange Book listing, modestly strengthening exclusivity, but it is a routine IP milestone rather than a market-moving event."},"tickerRelevance":{"others":[],"primary":"TVTX"},"globalImportance":22,"audienceRelevance":20,"eventTypeSecondary":["regulatory"],"importanceComponents":{"tickerTier":"small-cap biotech","eventGravity":"routine IP milestone","issuerAuthored":true,"exclusivityExtension":"patent coverage to October 2037"}},"event_type":"operations_update","event_type_secondary":["regulatory"],"sentiment":"bullish","material_impact_score":2,"narrative":"Travere Therapeutics received a Notice of Allowance from the USPTO for a U.S. patent application covering certain methods of using FILSPARI (sparsentan) in focal segmental glomerulosclerosis.\n\nUpon issuance, the patent is expected to provide U.S. coverage for these FSGS methods into October 2037, and Travere plans to list it in the FDA Orange Book promptly after grant.\n\nThe allowance complements a separate U.S. patent granted in August 2026 covering sparsentan methods in IgA nephropathy, extending the drug's intellectual-property moat.","key_figures":{"drugName":"FILSPARI (sparsentan)","customDimensions":{"patent_coverage_through":"October 2037","patent_application_number":"19/253,120"}},"named_entities":{"people":[],"products":["FILSPARI","sparsentan"],"companies":[{"name":"Travere Therapeutics, Inc.","ticker":"TVTX","relationship":"filer"},{"name":"U.S. Patent and Trademark Office (USPTO)","relationship":"regulator"},{"name":"U.S. Food and Drug Administration (FDA)","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-23T11:00:05.815Z","global_importance":22,"audience_relevance":20,"importance_components":{"tickerTier":"small-cap biotech","eventGravity":"routine IP milestone","issuerAuthored":true,"exclusivityExtension":"patent coverage to October 2037"}},"durationMs":4908,"modelName":"glm-5.3-flashx"}}