Drug facts
MoleculeOmeprazole
Generics already compete: 14 makers on the market. 39 A-rated products from 13 makers substitute at the counter.
Prilosec was first approved by the FDA on 09/14/1989 under NDA 019810; the application holder is Astrazeneca Pharmaceuticals LP. The Orange Book lists NDA 019810 as discontinued.
The latest NADAC for OMEPRAZOLE DR 40 MG CAPSULE is $0.05 per unit (as of 10/28/2026).
Holder Astrazeneca Pharmaceuticals LPApplication NDA 019810Approved 09/14/1989
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 Prilosec patent listed in the Orange Book Orange Book
- Later patents, other products
- Omeprazole (NDA 209400) 12/08/2036; Omeprazole (NDA 022032) 01/31/2030 Orange Book
02Competition
- Generics
- 14 generic makers Orange Book
- First generic approved
- 11/01/2002 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 Omeprazole profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.05 per unitOMEPRAZOLE DR 40 MG CAPSULE, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 06/30/2025Class II, Omeprazole, Dr. Reddy's Laboratories, Inc. FDA enforcement
04Product
- Application holder
- Astrazeneca Pharmaceuticals LP Orange Book
- Application
- NDA 019810 Orange Book
- First approved
- 09/14/1989 Orange Book
- Dosage forms
- capsule, delayed rel pellets; tablet, delayed release; tablet, orally disintegrating, delayed release
- Routes
- oral
- Status
- NDA 019810 discontinued Orange Book
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.