Amneal Pharmaceuticals has secured US Food and Drug Administration approval for its lanreotide injection, opening the door to an immediate launch of the generic version of SOMATULINE Depot in a market that generated $983 million in US sales over one year.

 

The FDA approved Amneal’s lanreotide injection, 120 mg/0.5 mL, in a sterile, single-dose prefilled syringe. The product also received the FDA’s Competitive Generic Therapy (CGT) designation.

 

Amneal said the product will launch immediately, adding another complex injectable to its growing Affordable Medicines portfolio.

 

“The approval and launch of lanreotide adds another material growth driver to our Affordable Medicines business,” said Srinivas Kone, Senior Vice President and Chief Scientific Officer – Affordable Medicines. 

 

“Lanreotide is a significant addition to our expanding complex injectables portfolio and reflects the strength of our integrated development and manufacturing capabilities. With dedicated, large-scale in-house manufacturing capacity, we are well positioned to reliably supply the market, broaden access to this important medicine and create meaningful long-term value for patients, providers, and shareholders.”

 

The market opportunity is substantial. US annual sales of SOMATULINE Depot reached $983 million for the 12 months ended July 2026, according to IQVIA.

 

Lanreotide injection is indicated for the treatment of acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome.

 

In acromegaly, the medicine helps control hormone levels. For eligible patients with GEP-NETs, it improves progression-free survival, while in patients with carcinoid syndrome, it reduces the need for rescue therapy.

 

The FDA approval strengthens Amneal’s position in complex injectables, an area in which the company says its integrated development and large-scale in-house manufacturing capabilities will support commercial supply.