FDA Orange Book
Generic for Somatuline Depot
Somatuline Depot contains lanreotide acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Somatuline Depot is lanreotide acetate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Somatuline Depot products the Orange Book lists.
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Somatuline Depot products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | Marketed (Rx) | AB | 1 | AB |
| solution, subcutaneous | EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | Marketed (Rx) | None | 0 | None |
NDA 022074, held by IPSEN PHARMA BIOTECH SAS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lanreotide acetate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 218217 | AB (A-rated, therapeutically equivalent) | September 18, 2026 | EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) |
Somatuline Depot NDC codes
Questions
Is there a generic for Somatuline Depot?
Yes. The generic name for Somatuline Depot is lanreotide acetate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Somatuline Depot products the Orange Book lists.
What is the generic name for Somatuline Depot?
The active ingredient in Somatuline Depot is lanreotide acetate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.