Amneal Pharmaceuticals Secures FDA Approval and Immediate Launch of Generic Lanreotide 120 mg Injection (Somatostatin Analog Peptide) with Competitive Generic Therapy Designation; Reference Product Somatuline Depot Had $983M in U.S. Annual Sales
Amneal Pharmaceuticals (NASDAQ: AMRX) announced Friday September 18, 2026 that the FDA approved and Amneal has immediately launched a generic lanreotide 120 mg / 0.5 mL sterile single-dose prefilled syringe injection referencing Ipsen's Somatuline Depot. Lanreotide is a long-acting somatostatin analog peptide indicated for adults with acromegaly, advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. The FDA granted Competitive Generic Therapy (CGT) designation — a 180-day marketing exclusivity for a first generic entrant in a market with limited competition. According to IQVIA data, U.S. annual sales of the reference product Somatuline Depot totaled $983 million for the 12 months ended July 2026. This is the first generic lanreotide to reach the U.S. market and opens material pricing competition for a peptide category that had been effectively single-source (Ipsen) for over 15 years since Somatuline Depot's original 2007 U.S. approval. Amneal joins a small group of peptide-generic producers with the technical capability to reproduce the depot-formulation octapeptide plus the extended-release delivery system.