Amneal Launches Mesalamine and Receives U.S. FDA Approval for Lenalidomide

Rhea-AI Summary

Amneal Pharmaceuticals (AMRX) has announced two significant developments: the launch of mesalamine 800 mg delayed-release tablets for treating moderately active ulcerative colitis in adults, and FDA approval for lenalidomide capsules in multiple strengths. Mesalamine represents a complex product with market suppliers, while lenalidomide will be available for sale starting January 31, 2026, following a settlement with Celgene.

The mesalamine market shows significant potential, with U.S. annual sales reaching approximately $147 million for the 12 months ended December 2024. The company views these developments as key drivers for sustainable business growth, particularly highlighting their R&D capabilities in complex drug manufacturing.

Positive

• Launch of mesalamine 800 mg tablets in a market worth $147 million annually
• FDA approval received for lenalidomide capsules in multiple strengths
• competition in mesalamine market due to manufacturing complexity

Negative

• Lenalidomide sales cannot begin until January 31, 2026 due to patent settlement

Insights

Pharmaceutical Industry Analyst

Amneal's dual announcement represents a significant expansion in their complex generics portfolio, with both immediate and future revenue catalysts. The mesalamine launch is particularly strategic, entering a $147 million market with competition due to manufacturing complexities. This high-barrier-to-entry product should command better margins compared to traditional generics, potentially capturing 15-20% market share within the first year.

The lenalidomide approval is even more significant from a long-term perspective. While the January 2026 launch date may seem distant, securing this approval now provides clear visibility into future revenue streams. The original REVLIMID® generated peak sales exceeding $12 billion globally, making this one of the most valuable generic opportunities in the oncology space. The settlement with Celgene, while restricting immediate entry, ensures a defined market entry timeline and likely includes volume or market share provisions typical in such agreements.

These developments showcase Amneal's evolution in complex product development:

• Mesalamine's supplier base indicates significant manufacturing barriers, suggesting sustained pricing power
• The successful development of lenalidomide across six different strengths demonstrates advanced R&D capabilities
• The combination of immediate (mesalamine) and future (lenalidomide) revenue streams helps balance the portfolio timeline

The market often underestimates the value of complex generic approvals, focusing instead on near-term revenues. However, these approvals significantly de-risk future growth prospects and validate Amneal's R&D capabilities in handling complex products. The company's strategic focus on difficult-to-manufacture products should support more sustainable margins compared to companies focused solely on conventional generics.

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

- Lenalidomide capsules, referencing REVLIMID^®

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250219548176/en/

Investor Contact

Anthony DiMeo

VP, Investor Relations

anthony.dimeo@amneal.com

Source: Amneal Pharmaceuticals, Inc.

FAQ

What is the market size for Amneal's (AMRX) newly launched mesalamine 800 mg tablets?

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

When will Amneal (AMRX) begin selling lenalidomide capsules?

Amneal will begin selling lenalidomide capsules in the U.S. on January 31, 2026, following a patent settlement with Celgene.

What strengths of lenalidomide capsules has Amneal (AMRX) received FDA approval for?

Amneal has received FDA approval for lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths.

What is the therapeutic use of Amneal's (AMRX) mesalamine 800 mg tablets?

Mesalamine 800 mg delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults.

What gives Amneal (AMRX) a competitive advantage in the mesalamine market?

Mesalamine is a difficult-to-manufacture product with a number of suppliers, giving Amneal an advantage due to their R&D capabilities in complex drug manufacturing.