Drug facts
MoleculeTizanidine (Zanaflex)
Generics already compete: 19 makers on the market. 51 A-rated products from 19 makers substitute at the counter.
Zanaflex was first approved by the FDA on 11/27/1996 under NDA 020397; the application holder is Legacy Pharma Inc Sezc.
The latest NADAC for TIZANIDINE HCL 4 MG CAPSULE is $0.10 per unit (as of 10/28/2026).
Holder Legacy Pharma Inc SezcApplication NDA 020397Approved 11/27/1996
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 Zanaflex patent listed in the Orange Book Orange Book
- Later patents, other products
- Ontralfy 05/07/2042 Orange Book
02Competition
- Generics
- 19 generic makers Orange Book
- First generic approved
- 06/27/2002 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 Tizanidine profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.10 per unitTIZANIDINE HCL 4 MG CAPSULE, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 01/02/2024Class II, Tizanidine, Dr. Reddy's Laboratories, Inc. FDA enforcement
04Product
- Application holder
- Legacy Pharma Inc Sezc Orange Book
- Application
- NDA 020397 Orange Book
- First approved
- 11/27/1996 Orange Book
- Dosage forms
- capsule; solution; tablet
- Routes
- oral
- Other brand names
- Ontralfy
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.