FDA Orange Book · active-ingredient family
Methylene blue
Methylene blue is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PROVAYBLUE · NDA 204630
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
2
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROVAYBLUERLD×2 | PROVEPHARM SAS | NDA 204630 | AP | Jul 18, 2019 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHYLENE BLUE×4 | ZYDUS LIFESCIENCES | ANDA 215636 | — | Feb 02, 2026 | |
| METHYLENE BLUE | CHENGDU SHUODE | ANDA 219550 | AP | Dec 23, 2025 | |
| METHYLENE BLUE | XIROMED | ANDA 219363 | AP | Jul 30, 2025 | |
| METHYLENE BLUE | MEITHEAL | ANDA 217380 | AP | Jan 23, 2025 | |
| METHYLENE BLUE | HIKMA | ANDA 216959 | AP | Dec 17, 2024 | |
| METHYLENE BLUE | STERISCIENCE | ANDA 216955 | AP | Nov 22, 2024 | |
| METHYLENE BLUE | NEXUS | ANDA 217561 | AP | Nov 21, 2024 |
Marketing exclusivity (2)
- M-303New use / labeling-change exclusivity (3 years)
Jan 08, 2027
in 7 mo
- M-303New use / labeling-change exclusivity (3 years)
Jan 08, 2027
in 7 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.
Methylene blue — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
