Methylene blue - Generic Drug Details

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

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.

Summary for methylene blue

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	113
Patent Applications:	6,927
Drug Prices:	Drug price trends for methylene blue
What excipients (inactive ingredients) are in methylene blue?	methylene blue excipients list
DailyMed Link:	methylene blue at DailyMed

See drug prices for methylene blue

Recent Clinical Trials for methylene blue

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

Sponsor	Phase
University of Rochester	Phase 2
University of Turin, Italy	Phase 2
Azienda Ospedaliera Città della Salute e della Scienza di Torino	Phase 2

See all methylene blue clinical trials

Pharmacology for methylene blue

Drug Class	Oxidation-Reduction Agent
Mechanism of Action	Oxidation-Reduction Activity

Medical Subject Heading (MeSH) Categories for methylene blue

Enzyme Inhibitors

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
Zydus Lifesciences	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	215636-001	Dec 5, 2023	AP	RX	No	No
Provepharm Sas	PROVAYBLUE	methylene blue	SOLUTION;INTRAVENOUS	204630-002	Jul 18, 2019	AP	RX	Yes	Yes
Provepharm Sas	PROVAYBLUE	methylene blue	SOLUTION;INTRAVENOUS	204630-001	Apr 8, 2016	AP	RX	Yes	Yes
Zydus Lifesciences	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	215636-002	Dec 5, 2023	AP	RX	No	No