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Last Updated: November 13, 2024

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
Drug Prices for MAFENIDE ACETATE

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Recent Clinical Trials for MAFENIDE ACETATE

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

SponsorPhase
Maricopa Integrated Health SystemN/A
PuriCore, Inc.N/A
Valleywise HealthN/A

See all MAFENIDE ACETATE clinical trials

Pharmacology for MAFENIDE ACETATE
Medical Subject Heading (MeSH) Categories for MAFENIDE ACETATE

US Patents and Regulatory Information for MAFENIDE ACETATE

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
Rising SULFAMYLON mafenide acetate CREAM;TOPICAL 016763-001 Approved Prior to Jan 1, 1982 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

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