Amneal Launches FDA-Approved Generic Lanreotide Injection

On September 18, 2026, Amneal Pharmaceuticals received approval from the U.S. Food and Drug Administration for its generic lanreotide injection and began commercial distribution on the same day.

The newly approved lanreotide injection is provided in a 120 mg/0.5 mL sterile, single-dose prefilled syringe. The FDA also designated this product as a Competitive Generic Therapy, a status intended to encourage the development of generic drugs where there is limited competition.

Lanreotide injection is indicated for treating acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. These conditions are managed with medications that help control hormone-related symptoms and tumor growth.

Amneal’s approval and immediate launch of lanreotide adds to its portfolio of complex injectable medicines. The company’s U.S. product range includes approximately 300 generic, specialty, and biosimilar medicines, which together account for over 160 million prescriptions annually.

What the numbers show

• FDA approval and commercial launch occurred on September 18, 2026.
• Lanreotide injection is available as a 120 mg/0.5 mL prefilled syringe.
• U.S. annual sales of Somatuline® Depot reached about $983 million in the 12 months ending July 2026.

According to Amneal, the FDA’s Competitive Generic Therapy designation is intended to increase market competition for drugs with limited alternatives. This designation can provide certain regulatory incentives to generic manufacturers.

Somatuline® Depot, a reference product for lanreotide, recorded U.S. sales of approximately $983 million in the 12 months ending July 2026. This figure highlights the market size for lanreotide-based therapies in the United States.

Amneal stated that the addition of lanreotide injection supports its strategy to expand offerings in complex generics and specialty medicines. The company’s portfolio covers a wide range of therapeutic areas and prescription volumes.

The FDA’s approval and Amneal’s immediate launch of lanreotide injection mark a new entry in the U.S. market for treatments targeting acromegaly and certain neuroendocrine tumors. The product’s availability as a generic option may impact prescribing patterns for these conditions.

* This article is based on publicly available information at the time of writing.