lanreotide acetate · Ipsen Pharma · NDA 022074
Somatuline Depot
Earliest generic entry, as listed · earliest of 3 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 218217, Amneal · 022074-001Approved 18 Sep 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022074 · 001 · RLD | solution, subcutaneous | EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | open |
| 022074 · 002 · RLD | solution, subcutaneous | EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | open |
| 022074 · 003 · RLD | solution, subcutaneous | EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | open |