Last Updated: May 3, 2026

methylene blue - Profile


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

Methylene blue is the generic ingredient in two branded drugs marketed by Chengdu Shuode, Hikma, Meitheal, Nexus, Steriscience, Xiromed, Zydus Lifesciences, and Provepharm Sas, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Summary for methylene blue
US Patents:0
Tradenames:2
Applicants:8
NDAs:8

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
Chengdu Shuode METHYLENE BLUE methylene blue SOLUTION;INTRAVENOUS 219550-001 Dec 23, 2025 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
Meitheal METHYLENE BLUE methylene blue SOLUTION;INTRAVENOUS 217380-001 Jan 23, 2025 AP RX No No ⤷  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
Steriscience METHYLENE BLUE methylene blue SOLUTION;INTRAVENOUS 216955-001 Nov 22, 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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