Drug facts
MoleculeLanreotide (Somatuline Depot)
Generics already compete: 1 maker on the market. 1 A-rated product from 1 maker substitute at the counter.
Somatuline Depot was first approved by the FDA on 08/30/2007 under NDA 022074; the application holder is Ipsen Pharma Biotech Sas.
The most recent FDA recall on record is a Class II recall dated 03/13/2026.
Holder Ipsen Pharma Biotech SasApplication NDA 022074Approved 08/30/2007
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
- Latest patent
- No Somatuline Depot patent listed in the Orange Book Orange Book
02Competition
- Generics
- 1 generic maker Orange Book
- First generic approved
- 05/21/2024 Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Lanreotide profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- Latest recall
- 03/13/2026Class II, Lanreotide Acetate, Cipla USA, Inc. FDA enforcement
04Product
- Application holder
- Ipsen Pharma Biotech Sas Orange Book
- Application
- NDA 022074 Orange Book
- First approved
- 08/30/2007 Orange Book
- Dosage forms
- solution
- Routes
- subcutaneous
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.