BACTRIM Drug Patent Profile

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Bactrim is a drug marketed by Sun Pharm Inds Inc and Sun Pharm Industries and is included in three NDAs.

The generic ingredient in BACTRIM is sulfamethoxazole; trimethoprim. There are twenty-seven drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sulfamethoxazole; trimethoprim profile page.

A generic version of BACTRIM was approved as sulfamethoxazole; trimethoprim by SUN PHARM INDUSTRIES on August 25^th, 1986.

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	63
Patent Applications:	4,036
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BACTRIM
DailyMed Link:	BACTRIM at DailyMed

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

Sponsor	Phase
Johns Hopkins University	Early Phase 1
National University Hospital, Singapore	Phase 3
Tan Tock Seng Hospital	Phase 3

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

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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
Sun Pharm Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Industries	BACTRIM DS	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Industries	BACTRIM	sulfamethoxazole; trimethoprim	TABLET;ORAL	017377-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Industries	BACTRIM PEDIATRIC	sulfamethoxazole; trimethoprim	SUSPENSION;ORAL	017560-002	Approved Prior to Jan 1, 1982		DISCN	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

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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 Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	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
Sun Pharm Inds Inc	BACTRIM	sulfamethoxazole; trimethoprim	INJECTABLE;INJECTION	018374-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering BACTRIM around the world.

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Country	Patent Number	Title	Estimated Expiration
Greece	35814	ΜΕΘΟΔΟΣ ΔΙΑ ΤΗΝ ΠΑΡΑΣΚΕΥΗΝ ΔΙΑΛΥΜΑΤΩΝ ΣΟΥΛΦΟΝΑΜΙΔΗΣ ΚΑΙ ΕΝΙΣΧΥΤΙΚΗΣ ΣΟΥΛΦΟΝΑΜΙΔΗΣ.	⤷ Try a Trial
Canada	1003331	COMPOSITION CONTAINING 5-METHYL-3- SULFANILAMIDOISOXAZOLE AND A BENZYL PYRIMIDINE	⤷ Try a Trial
Netherlands	140736		⤷ Try a Trial
Netherlands	6706474		⤷ Try a Trial
Spain	340262		⤷ Try a Trial
Japan	S5017524		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration