Home / Generic availability / Lanreotide
When will generic Lanreotide be available?
Based on the patents and exclusivity the FDA lists today, generic lanreotide cannot be marketed in the United States before 2027-03-20, when the last listed protection expires.
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| CGT | 2027-03-20 | Competitive generic therapy (180 days) | LANREOTIDE ACETATE |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| SOMATULINE DEPOT | Brand (NDA) | IPSEN PHARMA BIOTECH SAS | 2007-08-30 | reference listed drug, reference standard |
| LANREOTIDE ACETATE | Brand (NDA) | INVAGEN PHARMACEUTICALS INC | 2021-12-17 | reference listed drug |
| LANREOTIDE ACETATE | Generic (ANDA) | INVAGEN PHARMACEUTICALS INC | 2024-05-21 | |
| LANREOTIDE ACETATE | Generic (ANDA) | AMNEAL EU LTD | 2026-09-18 |
What a generic Lanreotide would have to match
Forms and strengths
Injection: 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL sterile, single-dose, prefilled syringes fitted with an automatic needle guard. The prefilled syringes contain a white to pale yellow, semi-solid formulation. Injection: 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL single-dose prefilled syringes ( 3 )
How it is supplied
Lanreotide Injection is supplied in strengths of 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL as a white to pale yellow, semi-solid formulation in a single, sterile, prefilled, ready-to-use, polypropylene syringe (fitted with an automatic needle guard) fitted with a 20 mm needle covered by a sheath. Each prefilled syringe is sealed in a laminated pouch and packed in a carton. NDC 69097-907-67 60 mg/0.2 mL, sterile, prefilled syringe NDC 69097-908-67 90 mg/0.3 mL, sterile, prefilled syringe NDC 69097-906-67 120 mg/0.5 mL, sterile, prefilled syringe Storage and Handling Store Lanreotide Injection in the refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in the original...
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2025-02-01.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Tirzepatideprotection runs to May 2027
- Octreotideprotection runs to June 2027
- Terlipressinprotection runs to September 2027
- Abaloparatideprotection runs to October 2027
- Macimorelinprotection runs to October 2027
Frequently asked questions
When will generic Lanreotide be available?
Based on the patents and exclusivity the FDA lists today, generic lanreotide cannot be marketed in the United States before 2027-03-20, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-11-01. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.
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