Drug facts
MoleculeBaclofen (Lioresal)
Generics already compete: 19 makers on the market. 58 A-rated products from 19 makers substitute at the counter.
Lioresal was first approved by the FDA before 1982 under NDA 017851; the application holder is Novartis Pharmaceuticals Corp. The Orange Book lists NDA 017851 as discontinued.
The latest NADAC for BACLOFEN 20 MG TABLET is $0.05 per unit (as of 10/28/2026).
Holder Novartis Pharmaceuticals CorpApplication NDA 017851Approved 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 Lioresal patent listed in the Orange Book Orange Book
- Later patents, other products
- Lyvispah 09/29/2041; Ozobax 08/30/2039; Fleqsuvy 09/29/2037 Orange Book
02Competition
- Generics
- 19 generic makers Orange Book
- First generic approved
- 05/06/1988 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 Baclofen profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.05 per unitBACLOFEN 20 MG TABLET, mid-priced of 4 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 11/26/2025Class II, Baclofen, Golden State Medical Supply Inc. FDA enforcement
04Product
- Application holder
- Novartis Pharmaceuticals Corp Orange Book
- Application
- NDA 017851 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- injectable; solution; suspension; tablet
- Routes
- intrathecal, oral
- Other brand names
- FleqsuvyGablofenOzobax Ds
- Status
- NDA 017851 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.