MYQORZO — FDA application NDA219083
Listed sponsor: CYTOKINETICS · CYTK company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10836755 | 001 | listed patent expiry date: 2039-01-18 | drug substance, drug product, U-4371 |
| Patent 10836755 | 002 | listed patent expiry date: 2039-01-18 | drug substance, drug product, U-4371 |
| Patent 10836755 | 003 | listed patent expiry date: 2039-01-18 | drug substance, drug product, U-4371 |
| Patent 10836755 | 004 | listed patent expiry date: 2039-01-18 | drug substance, drug product, U-4371 |
| Patent 12370179 | 001 | listed patent expiry date: 2042-07-15 | U-4371 |
| Patent 12370179 | 002 | listed patent expiry date: 2042-07-15 | U-4371 |
| Patent 12370179 | 003 | listed patent expiry date: 2042-07-15 | U-4371 |
| Patent 12370179 | 004 | listed patent expiry date: 2042-07-15 | U-4371 |
| Exclusivity NCE | 001 | listed exclusivity date: 2030-12-19 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2030-12-19 | FDA code as listed |
| Exclusivity NCE | 003 | listed exclusivity date: 2030-12-19 | FDA code as listed |
| Exclusivity NCE | 004 | listed exclusivity date: 2030-12-19 | FDA code as listed |
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 · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.