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:	160
Patent Applications:	6,849
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
Cairo University	Phase 4
Johns Hopkins University	Early Phase 1
Chang Gung Memorial Hospital	Phase 1/Phase 2

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
Mutual Pharm	SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH	sulfamethoxazole; trimethoprim	TABLET;ORAL	070007-001	Nov 14, 1984		DISCN	No	No
Superpharm	SULFATRIM-DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	070066-001	Jun 24, 1985		DISCN	No	No
Vista Pharms	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	076817-002	Oct 7, 2005	AB	RX	No	No
Sun Pharm Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Monarch Pharms	SEPTRA	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-001	Approved Prior to Jan 1, 1982	AB	RX	No	No
Usl Pharma	SULMEPRIM PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	070064-001	Aug 1, 1986		DISCN	No	No
Pliva	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	070216-001	Sep 10, 1985		DISCN	No	No