Drug facts
MoleculeDiclofenac Sodium (Voltaren Arthritis Pain)
Generics already compete: 31 makers on the market. 44 A-rated products from 29 makers substitute at the counter.
Voltaren was first approved by the FDA on 07/28/1988 under NDA 019201; the application holder is Novartis Pharmaceuticals Corp. The Orange Book lists NDA 019201 as discontinued.
The latest NADAC for DICLOFENAC SOD EC 75 MG TAB is $0.06 per unit (as of 10/28/2026).
Holder Novartis Pharmaceuticals CorpApplication NDA 019201Approved 07/28/1988
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 Voltaren patent listed in the Orange Book Orange Book
- Later patents, other products
- Pennsaid 08/09/2030; Dyloject 03/22/2027 Orange Book
02Competition
- Generics
- 31 generic makers Orange Book
- First generic approved
- 06/29/1995 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 Diclofenac Sodium profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.06 per unitDICLOFENAC SOD EC 75 MG TAB, mid-priced of 7 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 01/27/2026Class II, Diclofenac Sodium, Sun Pharmaceutical Industries Inc FDA enforcement
04Product
- Application holder
- Novartis Pharmaceuticals Corp Orange Book
- Application
- NDA 019201 Orange Book
- First approved
- 07/28/1988 Orange Book
- Dosage forms
- gel; solution; solution/drops; tablet, delayed release; tablet, extended release
- Routes
- intravenous, ophthalmic, oral, topical
- Other brand names
- Zueino
- Status
- NDA 019201 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.