SULFASALAZINE - Generic Drug Details

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What are the generic drug sources for sulfasalazine and what is the scope of patent protection?

Sulfasalazine is the generic ingredient in four branded drugs marketed by Pharmacia And Upjohn, Pfizer, Nuvo Pharms Inc, Watson Labs, Solvay, Chartwell, Epic Pharma Llc, Sun Pharm Industries, and Superpharm, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for sulfasalazine. Nine suppliers are listed for this compound.

Sponsor	Phase
Tanta University	Phase 3
Cairo University	Phase 3
Rutgers, The State University of New Jersey	Phase 2

Sponsor

Phase

Tanta University

Phase 3

Cairo University

Phase 3

Rutgers, The State University of New Jersey

Phase 2

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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 Industries	SULFASALAZINE	sulfasalazine	TABLET;ORAL	089590-001	Oct 19, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Nuvo Pharms Inc	SULFASALAZINE	sulfasalazine	TABLET;ORAL	040349-001	Jan 11, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Solvay	S.A.S.-500	sulfasalazine	TABLET;ORAL	083450-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	SULFASALAZINE	sulfasalazine	TABLET;ORAL	086184-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	AZULFIDINE EN-TABS	sulfasalazine	TABLET, DELAYED RELEASE;ORAL	007073-002	Apr 6, 1983	AB	RX	Yes	Yes	⤷ 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

US Patents:	0
Tradenames:	4
Applicants:	9
NDAs:	13
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	100
Patent Applications:	6,953
Drug Prices:	Drug price trends for SULFASALAZINE
What excipients (inactive ingredients) are in SULFASALAZINE?	SULFASALAZINE excipients list
DailyMed Link:	SULFASALAZINE at DailyMed