methylene blue · Provepharm Sas · NDA 204630
Provayblue
Earliest generic entry, as listed · earliest of 2 marketed strengths
8 Jan 2027
Blocked by exclusivity: M-303.
FDA has approved 1 generic application (ANDA) for Provayblue, though its earliest generic-entry date is 8 Jan 2027 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| M-303 | miscellaneous (3 years) | 8 Jan 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 219550, Chengdu Shuode · 204630-001Approved 23 Dec 2025Detected 25 Oct 2026Historical import
- Exclusivity expires within 90 days M-303 · 204630-001Exclusivity expires 8 Jan 2027Detected 24 Oct 2026
- Enters 12-month window basis: exclusivity · 204630-001Listed date 8 Jan 2027Detected 24 Oct 2026
- Exclusivity expires within 90 days M-303 · 204630-002Exclusivity expires 8 Jan 2027Detected 24 Oct 2026
- Enters 12-month window basis: exclusivity · 204630-002Listed date 8 Jan 2027Detected 24 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204630 · 001 · RLD | solution, intravenous | 50MG/10ML (5MG/ML) | 8 Jan 2027 |
| 204630 · 002 · RLD | solution, intravenous | 10MG/2ML (5MG/ML) | 8 Jan 2027 |