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Last Updated: July 10, 2020

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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, Hospira, Mylan Labs Ltd, Somerset, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Sun Pharm Industries, Ani Pharms Inc, Aurobindo Pharma, Hi Tech Pharma, Lannett Co Inc, 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, Superpharm, and Shionogi, and is included in sixty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for sulfamethoxazole; trimethoprim. Fifty suppliers are listed for this compound.

Summary for sulfamethoxazole; trimethoprim
Recent Clinical Trials for sulfamethoxazole; trimethoprim

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

SponsorPhase
Hellenic Institute for the Study of SepsisPhase 2
Atlantic Health SystemPhase 4
Johns Hopkins UniversityEarly Phase 1

See all sulfamethoxazole; trimethoprim clinical trials

US Patents and Regulatory Information for sulfamethoxazole; trimethoprim

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 018242-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Heather SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 018946-002 Aug 10, 1984 DISCN No No   Start Trial   Start Trial   Start Trial
Interpharm SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 071299-001 Oct 27, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries SULFAMETHOXAZOLE AND TRIMETHOPRIM sulfamethoxazole; trimethoprim TABLET;ORAL 071017-001 Aug 25, 1986 AB RX No No   Start Trial   Start Trial   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sun Pharm Industries BACTRIM DS sulfamethoxazole; trimethoprim TABLET;ORAL 017377-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Sun Pharm Inds Inc BACTRIM sulfamethoxazole; trimethoprim INJECTABLE;INJECTION 018374-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Monarch Pharms SEPTRA DS sulfamethoxazole; trimethoprim TABLET;ORAL 017376-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Sun Pharm Industries BACTRIM PEDIATRIC sulfamethoxazole; trimethoprim SUSPENSION;ORAL 017560-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Colorcon
Johnson and Johnson
Mallinckrodt
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.