Amneal Pharmaceuticals launches generic lanreotide injection in U.S

Amneal Pharmaceuticals has received FDA approval for its lanreotide injection (120 mg/0.5 mL) in a sterile, prefilled single-dose syringe. The company announced an immediate launch in the United States following the approval on September 18, 2026.

The generic product is positioned as a competitor to Ipsen’s Somatuline Depot, a brand that generated approximately $983 million in U.S. sales in the twelve months ending July 2026. Amneal’s product carries a Competitive Generic Therapy designation from the FDA.

Lanreotide is used to treat acromegaly, improve progression-free survival in patients with advanced gastroenteropancreatic neuroendocrine tumors, and reduce the need for rescue therapy in carcinoid syndrome. Amneal executives stated the product serves as a material growth driver for the company’s Affordable Medicines business.