Drug facts
MoleculeValsartan (Diovan)
Generics already compete: 18 makers on the market. 66 A-rated products from 18 makers substitute at the counter.
Diovan was first approved by the FDA on 12/23/1996 under NDA 020665; the application holder is Novartis Pharmaceuticals Corp. The Orange Book lists NDA 020665 as discontinued.
The latest NADAC for VALSARTAN 40 MG TABLET is $0.10 per unit (as of 10/28/2026).
Holder Novartis Pharmaceuticals CorpApplication NDA 020665Approved 12/23/1996
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 Diovan patent listed in the Orange Book Orange Book
02Competition
- Generics
- 18 generic makers Orange Book
- First generic approved
- 06/26/2014 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 Valsartan profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.10 per unitVALSARTAN 40 MG TABLET, mid-priced of 4 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 08/04/2026Class II, Valsartan, Novartis Pharmaceuticals Corporation FDA enforcement
04Product
- Application holder
- Novartis Pharmaceuticals Corp Orange Book
- Application
- NDA 020665 Orange Book
- First approved
- 12/23/1996 Orange Book
- Dosage forms
- solution; tablet
- Routes
- oral
- Other brand names
- Prexxartan
- Status
- NDA 020665 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.