Monitor Amneal's market share capture in the lanreotide market over the next 2-4 quarters, as CGT designation may accelerate uptake. Also watch for potential pricing erosion from additional generic entrants.
Price Chart
Executive Summary
Amneal Pharmaceuticals received FDA approval for its lanreotide injection (120 mg/0.5 mL), a generic version of Somatuline Depot, and launched it immediately. The product targets a $983 million U.S. market and benefits from Competitive Generic Therapy designation, positioning it as a material growth driver for Amneal's Affordable Medicines segment.
Key Facts
- FDA approved Amneal's lanreotide injection, 120 mg/0.5 mL, referencing Somatuline Depot.
- Product received Competitive Generic Therapy (CGT) designation from the FDA.
- Immediate commercial launch supported by in-house manufacturing capacity.
- U.S. annual sales for Somatuline Depot were $983 million for the 12 months ended July 2026 (IQVIA).
- Indicated for acromegaly, advanced GEP-NETs, and carcinoid syndrome.
Financial Impact
Addressable U.S. market of $983 million annually; Amneal's share will depend on pricing and competition, but CGT designation may provide market exclusivity advantages.
Risk Factors
- Competition from other generic manufacturers or branded Somatuline Depot could limit market share.
- Manufacturing or supply chain issues could delay consistent supply.
- Pricing pressure may reduce revenue contribution below market expectations.
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3364935 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 23, 2026 3d ago | 8-K/A | $20.38 | awaiting T+60 | — | $20.38 (−0.00%) |
Sep 18, 2026 5w ago | Press Release | $20.16 | awaiting T+60 | — | $20.38 (+1.09%) |
Aug 16, 2026 10w ago | Institutional Cluster | $18.42 | awaiting T+60 | — | $20.38 (+10.64%) |
Aug 14, 2026 10w ago | Insider Cluster | $18.42 | awaiting T+60 | — | $20.38 (+10.64%) |
Aug 13, 2026 10w ago | Insider Cluster | $18.15 | awaiting T+60 | — | $20.38 (−12.29%) |
Aug 10, 2026 11w ago | 8-K | $17.10 | awaiting T+60 | — | $20.38 (+19.18%) |
Jul 30, 2026 12w ago | DEFA14A | $18.50 $20.38 | ▲ +10.16% | ▲ +7.70% | $20.38 (+10.16%) |
Jul 17, 2026 14w ago | Press Release | $17.85 $20.03 | ▲ +12.21% | ▲ +7.53% | $20.38 (+14.17%) |
Jun 29, 2026 17w ago | DEFM14A | $17.29 $19.50 | ▲ +12.78% | ▲ +8.40% | $20.38 (+17.87%) |
Jun 29, 2026 17w ago | Press Release | $17.29 $19.50 | ▲ +12.78% | ▲ +8.40% | $20.38 (+17.87%) |
US Market Status
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