mavacamten · Bristol · NDA 214998
Camzyos
Earliest generic entry, as listed · earliest of 5 marketed strengths
28 Apr 2036
1 of 5 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US RE50050.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US RE50050 | drug substance, drug product · sets the listed date | 28 Apr 2036 |
| US 9585883 | use U-3373 | 19 Jun 2034 |
Exclusivities · 2 unexpired
| ODE-398 | orphan drug (7 years) | 28 Apr 2029 |
| NCE | new chemical entity (5 years) | 28 Apr 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214998 · 001 · RLD | capsule, oral | 2.5MG | 28 Apr 2036 |
| 214998 · 002 · RLD | capsule, oral | 5MG | 28 Apr 2036 |
| 214998 · 003 · RLD | capsule, oral | 10MG | 28 Apr 2036 |
| 214998 · 004 · RLD | capsule, oral | 15MG | 28 Apr 2036 |
| 214998 · 005 · RLD | capsule, oral | 1MG | open |
Expired or delisted (1)
- M-297 · 15 Jun 2026