Drug facts
MoleculeOxybutynin
Generics already compete: 22 makers on the market. 41 A-rated products from 22 makers substitute at the counter.
Ditropan was first approved by the FDA before 1982 under NDA 017577; the application holder is Janssen Pharmaceuticals Inc. The Orange Book lists NDA 017577 as discontinued.
The latest NADAC for OXYBUTYNIN 5 MG TABLET is $0.05 per unit (as of 10/28/2026).
Holder Janssen Pharmaceuticals IncApplication NDA 017577Approved before 1982
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 Ditropan patent listed in the Orange Book Orange Book
- Later patents, other products
- Gelnique 03/26/2031 Orange Book
02Competition
- Generics
- 22 generic makers Orange Book
- First generic approved
- 03/10/1988 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 Oxybutynin profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.05 per unitOXYBUTYNIN 5 MG TABLET, as of 10/28/2026 CMS NADAC
- Latest recall
- 10/19/2023Class II, Oxybutynin, Zydus Pharmaceuticals (USA) Inc FDA enforcement
04Product
- Application holder
- Janssen Pharmaceuticals Inc Orange Book
- Application
- NDA 017577 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- syrup; tablet; tablet, extended release
- Routes
- oral
- Status
- NDA 017577 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.