MAFENIDE ACETATE - Generic Drug Details

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

Mafenide acetate is the generic ingredient in two branded drugs marketed by Rising, Endo Operations, Novast Labs, and Mylan Institutional, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for mafenide acetate. Three suppliers are listed for this compound.

Summary for MAFENIDE ACETATE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	2
Patent Applications:	1,451
Drug Prices:	Drug price trends for MAFENIDE ACETATE
What excipients (inactive ingredients) are in MAFENIDE ACETATE?	MAFENIDE ACETATE excipients list
DailyMed Link:	MAFENIDE ACETATE at DailyMed

See drug prices for MAFENIDE ACETATE

Recent Clinical Trials for MAFENIDE ACETATE

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

Sponsor	Phase
PuriCore, Inc.	N/A
Valleywise Health	N/A
Maricopa Integrated Health System	N/A

See all MAFENIDE ACETATE clinical trials

Pharmacology for MAFENIDE ACETATE

Drug Class	Methylated Sulfonamide Antibacterial

Medical Subject Heading (MeSH) Categories for MAFENIDE ACETATE

Anti-Infective Agents, Local

Anatomical Therapeutic Chemical (ATC) Classes for MAFENIDE ACETATE

D06BA	Sulfonamides
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for MAFENIDE ACETATE

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Glossary

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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
Endo Operations	MAFENIDE ACETATE	mafenide acetate	FOR SOLUTION;TOPICAL	201511-001	Feb 12, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	MAFENIDE ACETATE	mafenide acetate	FOR SOLUTION;TOPICAL	206716-001	Jul 31, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Institutional	SULFAMYLON	mafenide acetate	FOR SOLUTION;TOPICAL	019832-003	Jun 5, 1998		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

Expired US Patents for MAFENIDE ACETATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	SULFAMYLON	mafenide acetate	CREAM;TOPICAL	016763-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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