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BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), a biopharmaceutical company with a market capitalization of $2.4 billion and "GREAT" financial health according to InvestingPro, announced the launch of its mesalamine 800 mg delayed-release tablets for treating moderately active ulcerative colitis in adults. InvestingPro analysis suggests the stock is currently fairly valued, with several positive indicators including expected net income growth this year. [Discover 5 more exclusive ProTips with InvestingPro.] The company also confirmed receiving U.S. Food and Drug Administration (FDA) approval for its lenalidomide capsules, which are slated for U.S. market release beginning January 31, 2026.
Mesalamine, a complex aminosalicylate medication, has a limited number of suppliers, underlining Amneal’s R&D capabilities. The FDA-approved lenalidomide, a thalidomide analogue, is indicated for several blood cancers, including multiple myeloma and myelodysplastic syndromes (MDS). The approval of lenalidomide is part of a settlement with Celgene (NASDAQ:CELG), which grants Amneal the license to manufacture and sell the generic version in the United States.
Andy Boyer, Executive Vice President and Chief Commercial Officer at Amneal, emphasized the approvals as evidence of the company’s ability to launch complex products and drive sustainable growth. He noted that lenalidomide represents a significant future growth driver in a large market.
The most common side effects associated with ASACOL HD® 800 mg, the reference product for Amneal’s mesalamine, include headaches, stomach pain, and nausea, among others. REVLIMID®, the reference product for lenalidomide, commonly causes neutropenia and thrombocytopenia.
According to data from IQVIA®, U.S. annual sales for mesalamine 800 mg amounted to approximately $147 million for the 12 months ending December 2024. The company has demonstrated strong growth, with revenue increasing by 12.3% over the last twelve months to $2.68 billion, supported by an EBITDA of $567 million.
Amneal Pharmaceuticals focuses on a broad range of complex product categories and therapeutic areas, including injectables and biosimilars in its Affordable Medicines segment, and branded pharmaceuticals primarily for central nervous system and endocrine disorders in its Specialty segment.
The information in this article is based on a press release statement from Amneal Pharmaceuticals. The company’s forward-looking statements are subject to various risks and uncertainties, as disclosed in its filings with the Securities and Exchange Commission. Analyst price targets range from $9 to $12 per share, reflecting optimistic growth expectations. [Get comprehensive insights with InvestingPro’s detailed Research Report, featuring expert analysis and over 30 key financial metrics.]
In other recent news, Amneal Pharmaceuticals has received FDA approval for three new therapies targeting dementia, oncology, and gastrointestinal conditions. The company has launched memantine/donepezil extended-release capsules for Alzheimer’s-related dementia with an exclusive 180-day marketing period. Additionally, everolimus tablets for oral suspension have been released to treat Tuberous Sclerosis Complex-associated tumors. The FDA has also granted tentative approval for Amneal’s rifaximin 550 mg oral tablets for adults with irritable bowel syndrome with diarrhea, pending the resolution of ongoing litigation. In another development, Amneal resubmitted a New Drug Application for its dihydroergotamine autoinjector, designed for acute migraine treatment, to the FDA. The company has also secured FDA approval for exenatide, a generic injectable glucagon-like peptide-1 agonist, marking a significant addition to its diabetes treatment portfolio. These approvals and submissions underline Amneal’s focus on expanding its differentiated product offerings. The recent developments are based on press release statements from Amneal Pharmaceuticals.
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