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Last Updated: July 13, 2024

METHYLENE BLUE - Generic Drug Details


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What are the generic drug sources for methylene blue and what is the scope of freedom to operate?

Methylene blue is the generic ingredient in two branded drugs marketed by Zydus Lifesciences and Provepharm Sas, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for methylene blue. Three suppliers are listed for this compound.

Drug Prices for METHYLENE BLUE

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Recent Clinical Trials for METHYLENE BLUE

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

SponsorPhase
University of RochesterPhase 2
University of Turin, ItalyPhase 2
Azienda Ospedaliera Città della Salute e della Scienza di TorinoPhase 2

See all METHYLENE BLUE clinical trials

Pharmacology for METHYLENE BLUE
Medical Subject Heading (MeSH) Categories for METHYLENE BLUE

US Patents and Regulatory Information for METHYLENE BLUE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Provepharm Sas PROVAYBLUE methylene blue SOLUTION;INTRAVENOUS 204630-002 Jul 18, 2019 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences METHYLENE BLUE methylene blue SOLUTION;INTRAVENOUS 215636-002 Dec 5, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Provepharm Sas PROVAYBLUE methylene blue SOLUTION;INTRAVENOUS 204630-001 Apr 8, 2016 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences METHYLENE BLUE methylene blue SOLUTION;INTRAVENOUS 215636-001 Dec 5, 2023 AP RX No 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

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