ANI Pharmaceuticals Inc (NASDAQ:ANIP) announced the launch of Carbamazepine Extended-Release Capsules in 100 mg, 200 mg, and 300 mg doses, according to a company statement.
The product is a generic alternative to the branded drug Carbatrol. Annual U.S. sales for carbamazepine extended-release capsules are estimated at around $65 million, based on IQVIA data for the 12 months ending February 2026. The launch comes as ANI continues to show strong financial momentum, with revenue rising 44% over the past year and a market capitalization of approximately $1.64 billion.
“The launch of Carbamazepine Extended-Release Capsules, another limited competition product, highlights our continued commitment to improving patient access to essential medicines while maintaining the highest standards of quality and compliance,” said Nikhil Lalwani, President and Chief Executive Officer of ANI.
Carbamazepine is an anticonvulsant commonly prescribed to treat epilepsy and other neurological disorders. The extended-release formulation allows for less frequent dosing compared with immediate-release versions.
ANI Pharmaceuticals develops, manufactures, and markets therapies across its Rare Disease, Generics, and Brands segments, with production facilities based in the United States.
In recent developments, the company reported strong fourth-quarter 2025 results, with earnings per share of $2.33, exceeding forecasts of $1.97. Revenue reached $247.1 million, ahead of expectations of $232.37 million.
ANI also recently launched generic Isosorbide Mononitrate Tablets in 10 mg and 20 mg strengths following final approval from the U.S. Food and Drug Administration. The product is a generic version of Monoket, used to prevent chest pain in patients with coronary artery disease.
Analyst sentiment remains positive. Jefferies reiterated a Buy rating with a $120 price target, noting expected “mid-teens” growth in Acthar revenue for 2026. Barclays also maintained an Overweight rating with a $100 target, citing strong fundamentals following the company’s earnings beat and favorable 2026 outlook.
Despite these developments, ANI’s shares continue to trade below their 52-week high.