Sulfadiazine - Generic Drug Details

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

Sulfadiazine is the generic ingredient in three branded drugs marketed by Abbvie, Chartwell Molecular, Epic Pharma Llc, Everylife, Impax Labs, Lederle, and Lilly, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for sulfadiazine. Two suppliers are listed for this compound.

Sponsor	Phase
Skingenix, Inc.	Phase 2
SCARM Institute, Tabriz, Iran	Phase 2
Shanghai Yueyang Integrated Medicine Hospital	Phase 2

Sponsor

Phase

Skingenix, Inc.

Phase 2

SCARM Institute, Tabriz, Iran

Phase 2

Shanghai Yueyang Integrated Medicine Hospital

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
Everylife	SULFADIAZINE	sulfadiazine	TABLET;ORAL	080088-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lilly	SULFONAMIDES DUPLEX	sulfadiazine; sulfamerazine	SUSPENSION;ORAL	006317-007	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lederle	SULFADIAZINE	sulfadiazine	TABLET;ORAL	004054-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Molecular	SULFADIAZINE	sulfadiazine	TABLET;ORAL	080084-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	SULFADIAZINE	sulfadiazine	TABLET;ORAL	040091-001	Jul 29, 1994		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	SULFADIAZINE	sulfadiazine	TABLET;ORAL	004125-005	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lilly	SULFADIAZINE	sulfadiazine	TABLET;ORAL	004122-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ 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:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	27
Patent Applications:	6,471
What excipients (inactive ingredients) are in sulfadiazine?	sulfadiazine excipients list
DailyMed Link:	sulfadiazine at DailyMed