Cipla gains USFDA approval for the generic version of Somatuline Depot (Lanreotide) injection

Cipla and its wholly owned subsidiary  Cipla USA (hereafter referred to as “Cipla”), announced that it has  received the final approval for its Abbreviated New Drug Application (ANDA) for  Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL from the United  States Food and Drug Administration (USFDA). 

Cipla’s Lanreotide Injection is an AP-rated therapeutic equivalent generic version of  Somatuline Depot (Lanreotide) Injection. Lanreotide Injection is supplied as 120  mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL single-dose, pre-filled, ready-to-inject syringe.  Cipla’s Lanreotide injection is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs). 

According to IQVIA (IMS Health), SomatulineDepot (Lanreotide) had US sales of approximately $898M for the 12-month period ending March 2024.