ANIP News & Events

ANI Pharmaceuticals announced the launch of Pimozide Tablets 1 mg and 2 mg. ANI's Pimozide Tablets is the generic version of the reference listed drug Orap. U.S. annual sales for Pimozide Tablets total approximately $3.1M, based on February 2026 moving annual total IQVIA data.

ANI Pharmaceuticals announced that following final approval from the FDA for its Abbreviated New Drug Application, or ANDA, the Company launched Isosorbide Mononitrate Tablet USP, 10 mg and 20 mg. ANI's Isosorbide Mononitrate Tablet USP is the generic version of the reference listed drug, or RLD, Monoket.

ANI Pharmaceuticals announced publication of the results from the NEW DAY clinical trial involving iluvien - fluocinolone acetonide intravitreal implant -, 0.19 mg for use in appropriate patients with diabetic macular edema in Ophthalmology, the journal of the American Academy of Ophthalmology. The company previously announced results from the NEW DAY trial in July 2025. Iiluvien is a corticosteroid indicated for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

Sees FY26 revenue $1.055B-$1.115B, consensus $1.04B. Sees FY26 adjusted EBITDA $275M-$290M.