Methylene blue
Methylene blue: 1 brand, 7 generics; first approved Apr 08, 2016; generic available.
Generic available: 7 ANDA applications approved.
Brand (NDA) products
- PROVEPHARM SASNDA 20463020192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP 10MG/2ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (7)
- METHYLENE BLUERSZYDUS LIFESCIENCESANDA 21563620264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/2ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP 5MG/ML (5MG/ML) SOLUTION INTRAVENOUS Rx - 100MG/10ML (10MG/ML) SOLUTION INTRAVENOUS Rx - - METHYLENE BLUECHENGDU SHUODEANDA 2195502025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP - METHYLENE BLUEXIROMEDANDA 2193632025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP - METHYLENE BLUEMEITHEALANDA 2173802025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP - METHYLENE BLUEHIKMAANDA 2169592024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP - METHYLENE BLUESTERISCIENCEANDA 2169552024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP - METHYLENE BLUENEXUSANDA 2175612024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/10ML (5MG/ML) SOLUTION INTRAVENOUS Rx AP
Patent & exclusivity timeline
Marketing exclusivity
- M-303New use / labeling-change exclusivity (3 years)
in 3 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2016–2026 across 8 FDA applications.
Methylene blue: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Assyro Intelligence
Ask anything about Methylene blue
Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.
Evaluating for a team? Book a demo