Trimethoprim - Generic Drug Details

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

Trimethoprim is the generic ingredient in five branded drugs marketed by Monarch Pharms, Dr Reddys Labs Sa, Novel Labs Inc, Novitium Pharma, Sun Pharm Industries, Teva, Watson Labs, Roche, and Allegis, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-four drug master file entries for trimethoprim. Six suppliers are listed for this compound.

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

Sponsor

Phase

Johns Hopkins University

Early Phase 1

The Cleveland Clinic

Phase 4

Assistance Publique - Hôpitaux de Paris

Phase 4

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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
Roche	TRIMPEX 200	trimethoprim	TABLET;ORAL	017952-002	Nov 9, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novitium Pharma	TRIMETHOPRIM	trimethoprim	TABLET;ORAL	216393-001	Oct 28, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allegis	PRIMSOL	trimethoprim hydrochloride	SOLUTION;ORAL	074374-001	Jun 23, 1995		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Monarch Pharms	PROLOPRIM	trimethoprim	TABLET;ORAL	017943-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	TRIMETHOPRIM	trimethoprim	TABLET;ORAL	018679-001	Jul 30, 1982	AB	RX	Yes	Yes	⤷ 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

US Patents:	0
Tradenames:	5
Applicants:	9
NDAs:	11
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	172
Clinical Trials:	183
Patent Applications:	7,123
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for trimethoprim
What excipients (inactive ingredients) are in trimethoprim?	trimethoprim excipients list
DailyMed Link:	trimethoprim at DailyMed

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