Last Updated: May 3, 2026

METHYLENE BLUE Drug Patent Profile

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When do Methylene Blue patents expire, and when can generic versions of Methylene Blue launch?

Methylene Blue is a drug marketed by Chengdu Shuode, Hikma, Meitheal, Nexus, Steriscience, Xiromed, and Zydus Lifesciences. and is included in seven NDAs.

The generic ingredient in METHYLENE BLUE is methylene blue. There are twenty-five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the methylene blue profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Methylene Blue

A generic version of METHYLENE BLUE was approved as methylene blue by ZYDUS LIFESCIENCES on December 5^th, 2023.

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Summary for METHYLENE BLUE

US Patents:	0
Applicants:	7
NDAs:	7

US Patents and Regulatory Information for METHYLENE BLUE

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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
Chengdu Shuode	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	219550-001	Dec 23, 2025	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Lifesciences	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	215636-003	Feb 2, 2026		RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Nexus	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	217561-001	Nov 21, 2024	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Lifesciences	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	215636-001	Dec 5, 2023	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	METHYLENE BLUE	methylene blue	SOLUTION;INTRAVENOUS	216959-001	Dec 17, 2024	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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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