Drug facts
MoleculeSulfamethoxazole and Trimethoprim (Bactrim)
Generics already compete: 11 makers on the market. 18 A-rated products from 11 makers substitute at the counter.
Bactrim was first approved by the FDA before 1982 under NDA 017377; the application holder is Sun Pharmaceutical Industries Inc.
The latest NADAC for SULFAMETHOXAZOLE-TMP SS TABLET is $0.04 per unit (as of 10/28/2026).
Holder Sun Pharmaceutical Industries IncApplication NDA 017377Approved 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 Bactrim patent listed in the Orange Book Orange Book
02Competition
- Generics
- 11 generic makers Orange Book
- First generic approved
- 11/07/1984 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 Sulfamethoxazole and Trimethoprim profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.04 per unitSULFAMETHOXAZOLE-TMP SS TABLET, as of 10/28/2026 CMS NADAC
- Latest recall
- 09/02/2025Class II, Sulfamethoxazole and Trimethoprim, The Harvard Drug Group LLC Dba Major Pharmaceuticals and Rugby Laboratories FDA enforcement
04Product
- Application holder
- Sun Pharmaceutical Industries Inc Orange Book
- Application
- NDA 017377 Orange Book
- First approved
- before 1982 Orange Book
- Dosage forms
- injectable; suspension; tablet
- Routes
- injection, oral
- Other brand names
- Sulfatrim Pediatric
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.