SULFISOXAZOLE - Generic Drug Details

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

Sulfisoxazole is the generic ingredient in nine branded drugs marketed by Roche, Mk Labs, Alra, Parke Davis, Ani Pharms, Barr, Heather, Hikma, Impax Labs, Lannett, Lederle, Pharmeral, Purepac Pharm, Rising, Roxane, Valeant Pharm Intl, Vitarine, Watson Labs, Solvay, and Sola Barnes Hind, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

Sponsor

Phase

Federal University of São Paulo

Phase 4

Fundação de Amparo à Pesquisa do Estado de São Paulo

Phase 4

James Graham Brown Cancer Center

Early Phase 1

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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	GANTRISIN PEDIATRIC	sulfisoxazole acetyl	SUSPENSION;ORAL	009182-004	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Lederle	SULFISOXAZOLE	sulfisoxazole	TABLET;ORAL	087649-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharmeral	SULFISOXAZOLE	sulfisoxazole	TABLET;ORAL	084385-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Lannett	SULFISOXAZOLE	sulfisoxazole	TABLET;ORAL	080085-001	Approved Prior to Jan 1, 1982		DISCN	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

US Patents:	0
Tradenames:	9
Applicants:	20
NDAs:	24
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	2
DailyMed Link:	SULFISOXAZOLE at DailyMed