Drug facts
MoleculeCyclobenzaprine
Generics already compete: 15 makers on the market. 39 A-rated products from 15 makers substitute at the counter.
Flexeril was first approved by the FDA before 1982 under NDA 017821; the application holder is Janssen Research and Development LLC. The Orange Book lists NDA 017821 as discontinued.
The latest NADAC for CYCLOBENZAPRINE 5 MG TABLET is $0.02 per unit (as of 10/28/2026).
Holder Janssen Research and Development LLCApplication NDA 017821Approved 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 Flexeril patent listed in the Orange Book Orange Book
- Later patents, other products
- Tonmya 03/14/2034 Orange Book
02Competition
- Generics
- 15 generic makers Orange Book
- First generic approved
- 05/03/1989 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 Cyclobenzaprine profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.02 per unitCYCLOBENZAPRINE 5 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 08/27/2025Class I, Cyclobenzaprine Hydrochloride, Unichem Pharmaceuticals USA Inc. FDA enforcement
04Product
- Application holder
- Janssen Research and Development LLC Orange Book
- Application
- NDA 017821 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- capsule, extended release; tablet
- Routes
- oral, sublingual
- Other brand names
- AmrixTonmya
- Status
- NDA 017821 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.