Drug facts
MoleculeIcosapent Ethyl (Vascepa)
Generics already compete: 12 makers on the market. 19 A-rated products from 12 makers substitute at the counter.
Vascepa was first approved by the FDA on 07/26/2012 under NDA 202057; the application holder is Amarin Pharmaceuticals Ireland Ltd.
The latest NADAC for ICOSAPENT ETHYL 500 MG CAPSULE is $0.35 per unit (as of 10/28/2026).
Holder Amarin Pharmaceuticals Ireland LtdApplication NDA 202057Approved 07/26/2012
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.
2,432days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved07/26/2012
Last patent06/28/2033
20132016201920222025202820312034
- Latest patent
- 06/28/2033Vascepa Orange Book
02Competition
- Generics
- 12 generic makers Orange Book
- First generic approved
- 05/21/2020 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 Icosapent Ethyl profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.35 per unitICOSAPENT ETHYL 500 MG CAPSULE, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 03/09/2026Class II, Icosapent Ethyl, Zydus Pharmaceuticals (USA) Inc FDA enforcement
04Product
- Application holder
- Amarin Pharmaceuticals Ireland Ltd Orange Book
- Application
- NDA 202057 Orange Book
- First approved
- 07/26/2012 Orange Book
- Dosage forms
- capsule
- Routes
- oral
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.