# MYQORZO — FDA application NDA219083

Informational only - not investment advice.

Application NDA219083 · type NDA · FDA status: approved · original approval 2025-12-19

Listed sponsor: CYTOKINETICS · [CYTK company profile](/company/CYTK/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | MYQORZO | AFICAMTEN | TABLET | ORAL | 5MG | Prescription | not listed | Yes |
| 002 | MYQORZO | AFICAMTEN | TABLET | ORAL | 10MG | Prescription | not listed | Yes |
| 003 | MYQORZO | AFICAMTEN | TABLET | ORAL | 15MG | Prescription | not listed | Yes |
| 004 | MYQORZO | AFICAMTEN | TABLET | ORAL | 20MG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10836755, product 001; listed patent expiry date: 2039-01-18.
- Patent 10836755, product 002; listed patent expiry date: 2039-01-18.
- Patent 10836755, product 003; listed patent expiry date: 2039-01-18.
- Patent 10836755, product 004; listed patent expiry date: 2039-01-18.
- Patent 12370179, product 001; listed patent expiry date: 2042-07-15.
- Patent 12370179, product 002; listed patent expiry date: 2042-07-15.
- Patent 12370179, product 003; listed patent expiry date: 2042-07-15.
- Patent 12370179, product 004; listed patent expiry date: 2042-07-15.
- Exclusivity NCE, product 001; listed exclusivity date: 2030-12-19.
- Exclusivity NCE, product 002; listed exclusivity date: 2030-12-19.
- Exclusivity NCE, product 003; listed exclusivity date: 2030-12-19.
- Exclusivity NCE, product 004; listed exclusivity date: 2030-12-19.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- AFICAMTEN · UNII B1I77MH6K1 · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/CYTK/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA219083. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.