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Last Updated: April 18, 2024

Sulfamethoxazole; trimethoprim - Generic Drug Details

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What are the generic drug sources for sulfamethoxazole; trimethoprim and what is the scope of freedom to operate?

Sulfamethoxazole; trimethoprim is the generic ingredient in twenty-two branded drugs marketed by Sun Pharm Inds Inc, Monarch Pharms, Abraxis Pharm, Bedford, Hikma, Hospira, Mylan Labs Ltd, Somerset, Teva Pharms Usa, Watson Labs, 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 Generics, Heather, Interpharm, Martec Usa Llc, Mutual Pharm, Pliva, Roxane, Vista Pharms, Heritage Pharma Avet, Superpharm, and Shionogi, and is included in sixty-six NDAs. Additional information is available in the individual branded drug profile pages.

Forty-nine suppliers are listed for this compound.

Summary for sulfamethoxazole; trimethoprim

US Patents:	0
Tradenames:	22
Applicants:	37
NDAs:	66
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	148
Patent Applications:	5,909
DailyMed Link:	sulfamethoxazole; trimethoprim at DailyMed

Recent Clinical Trials for sulfamethoxazole; trimethoprim

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Sponsor	Phase
Johns Hopkins University	Early Phase 1
The Cleveland Clinic	Phase 4
Assistance Publique - Hôpitaux de Paris	Phase 4

See all sulfamethoxazole; trimethoprim clinical trials

Pharmacology for sulfamethoxazole; trimethoprim

Drug Class	Dihydrofolate Reductase Inhibitor Antibacterial Sulfonamide Antimicrobial
Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2C9 Inhibitors Dihydrofolate Reductase Inhibitors Organic Cation Transporter 2 Inhibitors

US Patents and Regulatory Information for sulfamethoxazole; trimethoprim

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Labs Ltd	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	206607-001	Aug 30, 2017	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novel Labs Inc	SULFAMETHOPRIM-DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	070032-001	Feb 15, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vista Pharms	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	076817-001	Oct 7, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for sulfamethoxazole; trimethoprim

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Sun Pharm Industries	BACTRIM PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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