FDA Orange Book · active-ingredient family
Methylene blue
Methylene blue: 1 brand, 7 generics; first approved Apr 08, 2016; generic available.
Generic available2 exclusivity periods
Generic status & protection
Generic available: 7 ANDA applications approved.
Latest exclusivity ends
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
0
Presentations
12
Brand (NDA) products
Originator applications
- 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)
Abbreviated applications
- 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
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- M-303New use / labeling-change exclusivity (3 years)
in 5 mo
- M-303New use / labeling-change exclusivity (3 years)
in 5 mo
Listed patents
Orange Book patent file
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
FDA approval span
First approval
10 yr 6 mo ago
Most recent approval
5 mo ago
Approvals span 2016–2026 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
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.
