Drug facts
MoleculeMetformin
Generics already compete: 38 makers on the market. 121 A-rated products from 38 makers substitute at the counter.
Glucophage was first approved by the FDA on 03/03/1995 under NDA 020357; the application holder is Emd Serono Inc. The Orange Book lists NDA 020357 as discontinued.
The latest NADAC for METFORMIN HCL 850 MG TABLET is $0.02 per unit (as of 10/28/2026).
Holder Emd Serono IncApplication NDA 020357Approved 03/03/1995
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 Glucophage patent listed in the Orange Book Orange Book
- Later patents, other products
- Riomet ER 05/01/2035 Orange Book
02Competition
- Generics
- 38 generic makers Orange Book
- First generic approved
- 01/24/2002 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 Metformin profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.02 per unitMETFORMIN HCL 850 MG TABLET, mid-priced of 4 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 03/13/2025Class II, Metformin Hydrochloride Extended-Release..., Glenmark Pharmaceuticals Inc., USA FDA enforcement
04Product
- Application holder
- Emd Serono Inc Orange Book
- Application
- NDA 020357 Orange Book
- First approved
- 03/03/1995 Orange Book
- Dosage forms
- solution; tablet; tablet, extended release
- Routes
- oral
- Status
- NDA 020357 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.