FDA Orange Book
Is there a generic for Camzyos?
Camzyos contains mavacamten. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Camzyos (mavacamten). The Orange Book shows its last listed patent expires April 28, 2036 and its last listed exclusivity ends April 28, 2029.
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Camzyos products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 15MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 1MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 2.5MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 214998, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Camzyos patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9585883 | June 19, 2034 | Method of use | U-3373 | 214998 |
| RE50050 | April 28, 2036 | Drug substance, Drug product | None | 214998 |
Camzyos exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-297 | Miscellaneous | June 15, 2026 | 214998 |
| NCE | New chemical entity | April 28, 2027 | 214998 |
| ODE-398 | Orphan drug exclusivity | April 28, 2029 | 214998 |
Camzyos NDC codes
Questions
Is there a generic for Camzyos?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Camzyos (mavacamten). The Orange Book shows its last listed patent expires April 28, 2036 and its last listed exclusivity ends April 28, 2029.
What is the generic name for Camzyos?
The active ingredient in Camzyos is mavacamten, per the FDA Orange Book.
When does the Camzyos patent expire?
The last patent listed for Camzyos in the Orange Book expires April 28, 2036. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.