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 one branded drug marketed by Provepharm Sas and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for methylene blue. One supplier is listed for this compound.

Summary for methylene blue

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	107
Patent Applications:	6,515
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in methylene blue?	methylene blue excipients list
DailyMed Link:	methylene blue at DailyMed

Recent Clinical Trials for methylene blue

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

Sponsor	Phase
Nanjing First Hospital, Nanjing Medical University	Phase 3
Hugh Taylor	Early Phase 1
Multidisciplinary Association for Psychedelic Studies	Phase 1

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

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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
Provepharm Sas	PROVAYBLUE	methylene blue	SOLUTION;INTRAVENOUS	204630-002	Jul 18, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Provepharm Sas	PROVAYBLUE	methylene blue	SOLUTION;INTRAVENOUS	204630-001	Apr 8, 2016		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.