- Mesalamine 800 mg delayed-release tablets, referencing ASACOL HD^®

- Lenalidomide capsules, referencing REVLIMID^®

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced the launch of mesalamine 800 mg delayed-release tablets, an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. Additionally, the Company has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths. In settlement of all outstanding claims related to this product, Celgene agreed to provide Amneal with a license to Celgene’s patents required to manufacture and sell generic lenalidomide in the U.S. beginning on January 31, 2026. Lenalidomide, a thalidomide analogue, is indicated for the treatment of several blood cancers.

“Our ability to execute and continuously launch complex products is expanding our portfolio of affordable medicines and driving the sustainable growth of our business,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Affordable Medicines. “Mesalamine is a difficult to make product with a limited number of suppliers, and this approval highlights the strength of our R&D capabilities. Additionally, the approval of lenalidomide represents another key product approval in a large market that will be a future growth driver for us.”

The most common side effects reported with ASACOL HD^® 800 mg include headache, stomach pain, burping, nausea, sore throat, dizziness, weakness, and diarrhea. Less commonly, patients have experienced chest pain, menstrual cramps, swelling in the limbs, skin rash, and worsening of colitis. For full prescribing information, see package insert located here.

REVLIMID^® is a thalidomide analogue indicated for the treatment of adult patients with multiple myeloma and transfusion-dependent anemia due to myelodysplastic syndromes (MDS). Some of the most common adverse reactions reported while lenalidomide was used include neutropenia, thrombocytopenia and leukopenia. A more comprehensive list of the most common adverse reactions reported with REVLIMID^® are in the full prescribing information, see package insert located here.

According to IQVIA^®, U.S. annual sales for mesalamine 800 mg for the 12 months ended December 2024 were approximately $147 million.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit amneal.com and follow us on LinkedIn.

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

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