SULFAMETHOXAZOLE; TRIMETHOPRIM - Generic Drug Details

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What are the generic 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 Pharms Ltd, 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-eight suppliers are listed for this compound.

Summary for SULFAMETHOXAZOLE; TRIMETHOPRIM

US Patents:	0
Tradenames:	22
Applicants:	37
NDAs:	66
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	151
Patent Applications:	5,909
DailyMed Link:	SULFAMETHOXAZOLE; TRIMETHOPRIM at DailyMed

Recent Clinical Trials for SULFAMETHOXAZOLE; TRIMETHOPRIM

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; 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

Anatomical Therapeutic Chemical (ATC) Classes for SULFAMETHOXAZOLE; TRIMETHOPRIM

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
Superpharm	SULFATRIM-DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	070066-001	Jun 24, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Monarch Pharms	SEPTRA	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017598-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	070028-001	Jun 2, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	BACTRIM DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Monarch Pharms	SEPTRA DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-002	Approved Prior to Jan 1, 1982	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Sun Pharm Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Monarch Pharms	SEPTRA DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017376-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Sun Pharm Industries	BACTRIM DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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