PEMAZYRE — FDA application NDA213736
Listed sponsor: INCYTE CORP · INCY 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 | PEMAZYRE | PEMIGATINIB | TABLET | ORAL | 4.5MG | Prescription | not listed | Yes |
| 002 | PEMAZYRE | PEMIGATINIB | TABLET | ORAL | 9MG | Prescription | not listed | Yes |
| 003 | PEMAZYRE | PEMIGATINIB | TABLET | ORAL | 13.5MG | 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 10131667 | 001 | listed patent expiry date: 2034-04-17 | U-2809 |
| Patent 10131667 | 002 | listed patent expiry date: 2034-04-17 | U-2809 |
| Patent 10131667 | 003 | listed patent expiry date: 2034-04-17 | U-2809 |
| Patent 9611267 | 001 | listed patent expiry date: 2035-01-30 | drug substance, drug product |
| Patent 9611267 | 002 | listed patent expiry date: 2035-01-30 | drug substance, drug product |
| Patent 9611267 | 003 | listed patent expiry date: 2035-01-30 | drug substance, drug product |
| Patent 11466004 | 001 | listed patent expiry date: 2039-05-03 | U-3464 |
| Patent 11466004 | 001 | listed patent expiry date: 2039-05-03 | U-3465 |
| Patent 11466004 | 001 | listed patent expiry date: 2039-05-03 | U-3466 |
| Patent 11466004 | 002 | listed patent expiry date: 2039-05-03 | U-3464 |
| Patent 11466004 | 002 | listed patent expiry date: 2039-05-03 | U-3465 |
| Patent 11466004 | 002 | listed patent expiry date: 2039-05-03 | U-3466 |
| Patent 11466004 | 003 | listed patent expiry date: 2039-05-03 | U-3464 |
| Patent 11466004 | 003 | listed patent expiry date: 2039-05-03 | U-3465 |
| Patent 11466004 | 003 | listed patent expiry date: 2039-05-03 | U-3466 |
| Patent 11628162 | 001 | listed patent expiry date: 2040-08-30 | U-3568 |
| Patent 11628162 | 001 | listed patent expiry date: 2040-08-30 | U-3569 |
| Patent 11628162 | 001 | listed patent expiry date: 2040-08-30 | U-3570 |
| Patent 11628162 | 001 | listed patent expiry date: 2040-08-30 | U-3571 |
| Patent 11628162 | 002 | listed patent expiry date: 2040-08-30 | U-3568 |
| Patent 11628162 | 002 | listed patent expiry date: 2040-08-30 | U-3569 |
| Patent 11628162 | 002 | listed patent expiry date: 2040-08-30 | U-3570 |
| Patent 11628162 | 002 | listed patent expiry date: 2040-08-30 | U-3571 |
| Patent 11628162 | 003 | listed patent expiry date: 2040-08-30 | U-3569 |
| Patent 11628162 | 003 | listed patent expiry date: 2040-08-30 | U-3568 |
| Patent 11628162 | 003 | listed patent expiry date: 2040-08-30 | U-3570 |
| Patent 11628162 | 003 | listed patent expiry date: 2040-08-30 | U-3571 |
| Patent 12552792 | 001 | listed patent expiry date: 2040-10-03 | drug substance, drug product |
| Patent 12552792 | 002 | listed patent expiry date: 2040-10-03 | drug substance, drug product |
| Patent 12552792 | 003 | listed patent expiry date: 2040-10-03 | drug substance, drug product |
| Exclusivity ODE-292 | 001 | listed exclusivity date: 2027-04-17 | FDA code as listed |
| Exclusivity ODE-292 | 002 | listed exclusivity date: 2027-04-17 | FDA code as listed |
| Exclusivity ODE-292 | 003 | listed exclusivity date: 2027-04-17 | FDA code as listed |
| Exclusivity ODE-404 | 001 | listed exclusivity date: 2029-08-26 | FDA code as listed |
| Exclusivity ODE-404 | 002 | listed exclusivity date: 2029-08-26 | FDA code as listed |
| Exclusivity ODE-404 | 003 | listed exclusivity date: 2029-08-26 | 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
- PEMIGATINIB · UNII Y6BX7BL23K · lmmol compound HCDMJFOHIXMBOV-UHFFFAOYSA-N · CHEMBL4297522
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.