{"success":true,"data":{"pressRelease":{"id":"150623","rtpr_id":"nGNX41vknK-20260923","ticker":"ANIP","exchange":"NASDAQ","all_tickers":["ANIP"],"title":"ANI Pharmaceuticals Announces the FDA Approval of Everolimus Tablets for Oral Suspension","author":"Globe Newswire","published_at":"2026-09-23T10:55:00.096Z","article_body":"PRINCETON, N.J., Sept. 23, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc.\n(ANI or the Company) (Nasdaq: ANIP) today announced that it received final\napproval from the U.S. Food and Drug Administration (FDA) for its Abbreviated\nNew Drug Application (ANDA), for Everolimus Tablets for Oral Suspension 2mg,\n3mg and 5mg. ANI’s Everolimus Tablets for Oral Suspension are the generic\nversion of the reference listed drug (RLD) Afinitor Disperz(®).\n\n\"The FDA approval of Everolimus Tablets for Suspension is another example of\nour R&D team's continued execution on technically demanding formulations, and\nthe launch adds further momentum to our commercial portfolio.  Our U.S.\nfocused generics business continues to produce outstanding results, and we\nremain on track to launch at least 15 new generics this year,” stated Nikhil\nLalwani, President and Chief Executive Officer of ANI.\n\nU.S. annual sales for Everolimus Tablet for Oral Suspension totaled\napproximately $123 million, based on July 2026 moving annual total (MAT) IQVIA\ndata.\n\nAbout ANI Pharmaceuticals, Inc.\n\nANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical\ncompany committed to its mission of “Serving Patients, Improving Lives\" by\ndeveloping, manufacturing, and commercializing innovative and high-quality\ntherapeutics. The Company is focused on delivering sustainable growth through\nits Rare Disease business, which markets novel products in the areas of\nophthalmology, rheumatology, nephrology, neurology, and pulmonology; its\nGenerics business, which leverages R&D expertise, operational excellence, and\nU.S.-based manufacturing; and its Brands business. For more information, visit\nhttps://www.anipharmaceuticals.com.\n\nForward-Looking Statements\n\nTo the extent any statements made in this release relate to information that\nis not historical, these are forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995. Such statements include,\nbut are not limited to, statements regarding the Company’s strategy; its\nplans with respect to the commercialization and potential sales of the\nCompany’s products, including the launch of Everolimus; its efforts to bring\nlimited-competition products to market and ensure that is high-quality\nproducts are readily accessible to its customers and patients in need;\nexpansion plans for the Company’s Rare Disease, Generics and Brands\nbusinesses; and other statements that are not historical in nature,\nparticularly those that utilize terminology such as “anticipates,”\n“will,” “expects,” “plans,” “potential,” “future,”\n“believes,” “intends,” “continue,” the negatives thereof, or other\nwords of similar meaning, derivations of such words and the use of future\ndates.\n\nUncertainties and risks may cause the Company’s actual results to be\nmaterially different than those expressed in or implied by such\nforward-looking statements. Uncertainties and risks include, but are not\nlimited to: the ability of the Company’s approved products to achieve\ncommercialization at levels of market acceptance that will allow the Company\nto maintain profitability; delays and disruptions in the production of the\nCompany’s approved products; delays or failure to obtain or maintain\napprovals by the FDA of the Company’s products; changes in policy or actions\nthat may be taken by the FDA, United States Drug Enforcement Administration\nand other regulatory agencies; risks that the Company may face with respect to\nimporting raw materials and delays in delivery of raw materials and other\ningredients and supplies necessary for the manufacture of the Company’s\nproducts from both domestic and overseas sources due to supply chain\ndisruptions or for any other reason; the limited number of suppliers for\nactive pharmaceuticals ingredients for our products; the ability of the\nCompany’s manufacturing partners to meet its product demands and timelines;\nthe level of competition the Company faces and the legal, regulatory and/or\nlegislative strategies employed by its competitors to prevent or delay\ncompetition from generic alternatives to branded products; the impact of\nlegislative or regulatory reform on the pricing for pharmaceutical products;\nthe Company’s ability, and that of its suppliers, development partners, and\nmanufacturing partners, to comply with laws, regulations and standards that\ngovern or affect the pharmaceutical and biotechnology industries; legal\nproceedings and product liability claims relating to our products and our\nbusiness; and general business and economic conditions, such as inflationary\npressures and geopolitical conditions.\n\nMore detailed information on these and additional factors that could affect\nthe Company’s actual results are described in the Company’s filings with\nthe Securities and Exchange Commission (SEC), including its most recent annual\nreport on Form 10-K and quarterly reports on Form 10-Q, and other periodic\nreports, as well as other filings with the SEC. All forward-looking statements\nin this news release speak only as of the date of this news release and are\nbased on the Company’s current beliefs, assumptions, and expectations. The\nCompany undertakes no obligation to update or revise any forward-looking\nstatement, whether as a result of new information, future events or otherwise.\n\nInvestor Relations:\nIrina Koffler, Vice President, Investor Relations\nT: 917-734-7387\nE: Irina.koffler@anipharmaceuticals.com\n\nMedia Relations:\nArgot Partners\nT: 212-600-1494\nE: ani@argotpartners.com\n\nSource: ANI Pharmaceuticals, Inc.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/24d1d851-9075-4d6e-b22c-0c23a5ef0b36)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX41vknK-20260923","title":"ANI Pharmaceuticals Announces the FDA Approval of Everolimus Tablets for Oral Suspension","author":"Globe Newswire","ticker":"ANIP","created":"2026-09-23T10:55:00.096Z","tickers":["ANIP"],"exchange":"NASDAQ","article_body":"PRINCETON, N.J., Sept. 23, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc.\n(ANI or the Company) (Nasdaq: ANIP) today announced that it received final\napproval from the U.S. Food and Drug Administration (FDA) for its Abbreviated\nNew Drug Application (ANDA), for Everolimus Tablets for Oral Suspension 2mg,\n3mg and 5mg. ANI’s Everolimus Tablets for Oral Suspension are the generic\nversion of the reference listed drug (RLD) Afinitor Disperz(®).\n\n\"The FDA approval of Everolimus Tablets for Suspension is another example of\nour R&D team's continued execution on technically demanding formulations, and\nthe launch adds further momentum to our commercial portfolio.  Our U.S.\nfocused generics business continues to produce outstanding results, and we\nremain on track to launch at least 15 new generics this year,” stated Nikhil\nLalwani, President and Chief Executive Officer of ANI.\n\nU.S. annual sales for Everolimus Tablet for Oral Suspension totaled\napproximately $123 million, based on July 2026 moving annual total (MAT) IQVIA\ndata.\n\nAbout ANI Pharmaceuticals, Inc.\n\nANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical\ncompany committed to its mission of “Serving Patients, Improving Lives\" by\ndeveloping, manufacturing, and commercializing innovative and high-quality\ntherapeutics. The Company is focused on delivering sustainable growth through\nits Rare Disease business, which markets novel products in the areas of\nophthalmology, rheumatology, nephrology, neurology, and pulmonology; its\nGenerics business, which leverages R&D expertise, operational excellence, and\nU.S.-based manufacturing; and its Brands business. For more information, visit\nhttps://www.anipharmaceuticals.com.\n\nForward-Looking Statements\n\nTo the extent any statements made in this release relate to information that\nis not historical, these are forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995. Such statements include,\nbut are not limited to, statements regarding the Company’s strategy; its\nplans with respect to the commercialization and potential sales of the\nCompany’s products, including the launch of Everolimus; its efforts to bring\nlimited-competition products to market and ensure that is high-quality\nproducts are readily accessible to its customers and patients in need;\nexpansion plans for the Company’s Rare Disease, Generics and Brands\nbusinesses; and other statements that are not historical in nature,\nparticularly those that utilize terminology such as “anticipates,”\n“will,” “expects,” “plans,” “potential,” “future,”\n“believes,” “intends,” “continue,” the negatives thereof, or other\nwords of similar meaning, derivations of such words and the use of future\ndates.\n\nUncertainties and risks may cause the Company’s actual results to be\nmaterially different than those expressed in or implied by such\nforward-looking statements. Uncertainties and risks include, but are not\nlimited to: the ability of the Company’s approved products to achieve\ncommercialization at levels of market acceptance that will allow the Company\nto maintain profitability; delays and disruptions in the production of the\nCompany’s approved products; delays or failure to obtain or maintain\napprovals by the FDA of the Company’s products; changes in policy or actions\nthat may be taken by the FDA, United States Drug Enforcement Administration\nand other regulatory agencies; risks that the Company may face with respect to\nimporting raw materials and delays in delivery of raw materials and other\ningredients and supplies necessary for the manufacture of the Company’s\nproducts from both domestic and overseas sources due to supply chain\ndisruptions or for any other reason; the limited number of suppliers for\nactive pharmaceuticals ingredients for our products; the ability of the\nCompany’s manufacturing partners to meet its product demands and timelines;\nthe level of competition the Company faces and the legal, regulatory and/or\nlegislative strategies employed by its competitors to prevent or delay\ncompetition from generic alternatives to branded products; the impact of\nlegislative or regulatory reform on the pricing for pharmaceutical products;\nthe Company’s ability, and that of its suppliers, development partners, and\nmanufacturing partners, to comply with laws, regulations and standards that\ngovern or affect the pharmaceutical and biotechnology industries; legal\nproceedings and product liability claims relating to our products and our\nbusiness; and general business and economic conditions, such as inflationary\npressures and geopolitical conditions.\n\nMore detailed information on these and additional factors that could affect\nthe Company’s actual results are described in the Company’s filings with\nthe Securities and Exchange Commission (SEC), including its most recent annual\nreport on Form 10-K and quarterly reports on Form 10-Q, and other periodic\nreports, as well as other filings with the SEC. All forward-looking statements\nin this news release speak only as of the date of this news release and are\nbased on the Company’s current beliefs, assumptions, and expectations. The\nCompany undertakes no obligation to update or revise any forward-looking\nstatement, whether as a result of new information, future events or otherwise.\n\nInvestor Relations:\nIrina Koffler, Vice President, Investor Relations\nT: 917-734-7387\nE: Irina.koffler@anipharmaceuticals.com\n\nMedia Relations:\nArgot Partners\nT: 212-600-1494\nE: ani@argotpartners.com\n\nSource: ANI Pharmaceuticals, Inc.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/24d1d851-9075-4d6e-b22c-0c23a5ef0b36)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-23T10:55:00.144081352Z","server_sent_at_ms":1790160900144},"received_at":"2026-09-23T10:55:00.198Z","source_url":null},"analysis":{"id":"139425","press_release_id":"150623","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":[],"eventType":"fda_approval","narrative":"ANI Pharmaceuticals received final FDA approval of its ANDA for Everolimus Tablets for Oral Suspension in 2mg, 3mg and 5mg strengths, the generic version of Afinitor Disperz.\n\nThe addressable U.S. market is approximately $123 million in annual sales based on July 2026 IQVIA moving annual total data.\n\nCEO Nikhil Lalwani highlighted the approval as evidence of R&D execution on technically demanding formulations, with the company still on track to launch at least 15 new generics this year.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"ANI adds a $123M-market technically demanding generic to its launch pipeline — first-mover competition question worth watching."},"keyFigures":{"drugName":"Everolimus Tablets for Oral Suspension (generic of Afinitor Disperz)","customDimensions":{"us_annual_sales_market":"$123 million","planned_new_generics_2026":15}},"quotedText":"The FDA approval of Everolimus Tablets for Suspension is another example of our R&D team's continued execution on technically demanding formulations, and the launch adds further momentum to our commercial portfolio.","namedEntities":{"people":[{"name":"Nikhil Lalwani","role":"President and CEO"},{"name":"Irina Koffler","role":"Vice President, Investor Relations"}],"products":["Everolimus Tablets for Oral Suspension","Afinitor Disperz"],"companies":[{"name":"ANI Pharmaceuticals, Inc.","ticker":"ANIP","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[{"amount":"$123 million","context":"U.S. annual sales for Everolimus Tablets for Oral Suspension (July 2026 MAT IQVIA data)"}]},"materialImpact":{"score":3,"reasoning":"Final FDA approval of a technically demanding generic (Everolimus, generic of Afinitor Disperz) addresses a ~$123 million U.S. market, but it is one of at least 15 planned generic launches this year — incremental rather than transformative for a diversified biopharma."},"tickerRelevance":{"others":[],"primary":"ANIP"},"globalImportance":35,"audienceRelevance":25,"eventTypeSecondary":["product_launch"],"importanceComponents":{"tickerTier":"mid-cap","eventGravity":"generic ANDA approval, ~$123M market","sectorWeight":"pharma generics pipeline momentum","issuerAuthored":true}},"event_type":"fda_approval","event_type_secondary":["product_launch"],"sentiment":"bullish","material_impact_score":3,"narrative":"ANI Pharmaceuticals received final FDA approval of its ANDA for Everolimus Tablets for Oral Suspension in 2mg, 3mg and 5mg strengths, the generic version of Afinitor Disperz.\n\nThe addressable U.S. market is approximately $123 million in annual sales based on July 2026 IQVIA moving annual total data.\n\nCEO Nikhil Lalwani highlighted the approval as evidence of R&D execution on technically demanding formulations, with the company still on track to launch at least 15 new generics this year.","key_figures":{"drugName":"Everolimus Tablets for Oral Suspension (generic of Afinitor Disperz)","customDimensions":{"us_annual_sales_market":"$123 million","planned_new_generics_2026":15}},"named_entities":{"people":[{"name":"Nikhil Lalwani","role":"President and CEO"},{"name":"Irina Koffler","role":"Vice President, Investor Relations"}],"products":["Everolimus Tablets for Oral Suspension","Afinitor Disperz"],"companies":[{"name":"ANI Pharmaceuticals, Inc.","ticker":"ANIP","relationship":"filer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[{"amount":"$123 million","context":"U.S. annual sales for Everolimus Tablets for Oral Suspension (July 2026 MAT IQVIA data)"}]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-23T10:55:05.636Z","global_importance":35,"audience_relevance":25,"importance_components":{"tickerTier":"mid-cap","eventGravity":"generic ANDA approval, ~$123M market","sectorWeight":"pharma generics pipeline momentum","issuerAuthored":true}},"durationMs":5428,"modelName":"glm-5.3-flashx"}}