SULFAMETHOXAZOLE - Generic Drug Details

What are the generic drug sources for sulfamethoxazole and what is the scope of patent protection?

Sulfamethoxazole is the generic ingredient in twenty-six branded drugs marketed by Roche, Ascot, Barr, Heather, Rising, Watson Labs, Shionogi, Sun Pharm Inds Inc, Monarch Pharms, Abraxis Pharm, Bedford, Hikma, Hospira, Mylan Labs Ltd, Somerset, Teva Pharms Usa, Sun Pharm Industries, Ani Pharms, Aurobindo Pharma, Chartwell Molecular, Lupin Ltd, Novitium Pharma, Prasco, Teva, Pharm Assoc, Usl Pharma, Alpharma Us Pharms, Naska, Novel Labs Inc, Amneal Pharms Ny, Chartwell Molecules, Fosun Pharma, Glenmark Pharms Ltd, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Vista Pharms, Heritage Pharma Avet, and Superpharm, and is included in seventy-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for sulfamethoxazole.

Summary for SULFAMETHOXAZOLE

US Patents:	0
Tradenames:	26
Applicants:	41
NDAs:	75
Drug Master File Entries:	27
Raw Ingredient (Bulk) Api Vendors:	161
Clinical Trials:	158
Patent Applications:	6,545
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for SULFAMETHOXAZOLE
DailyMed Link:	SULFAMETHOXAZOLE at DailyMed

See drug prices for SULFAMETHOXAZOLE

Recent Clinical Trials for SULFAMETHOXAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Johns Hopkins University	Early Phase 1
Walter Reed National Military Medical Center	Phase 2
The Cleveland Clinic	Phase 4

See all SULFAMETHOXAZOLE clinical trials

Medical Subject Heading (MeSH) Categories for SULFAMETHOXAZOLE

Anti-Infective Agents

Anatomical Therapeutic Chemical (ATC) Classes for SULFAMETHOXAZOLE

J01EC	Intermediate-acting sulfonamides
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for SULFAMETHOXAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	090624-001	Feb 16, 2010	AB	RX	No	No
Roche	GANTANOL	sulfamethoxazole	TABLET;ORAL	012715-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Teva	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	018812-001	Jan 28, 1983		DISCN	No	No
Usl Pharma	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	070204-001	Nov 8, 1985		DISCN	No	No
Prasco	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	077612-001	Nov 13, 2006	AB	RX	No	No
Glenmark Pharms Ltd	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	090828-001	Dec 22, 2010	AB	RX	No	No
Novel Labs Inc	SULFAMETHOPRIM-DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	070032-001	Feb 15, 1985		DISCN	No	No