# OPZELURA — FDA application NDA215309

Informational only - not investment advice.

Application NDA215309 · type NDA · FDA status: approved · original approval 2021-09-21

Listed sponsor: INCYTE CORP · [INCY company profile](/company/INCY/) · 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 | OPZELURA | RUXOLITINIB PHOSPHATE | CREAM | TOPICAL | EQ 1.5% BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10639310, product 001; listed patent expiry date: 2026-12-12.
- Patent 9079912, product 001; listed patent expiry date: 2026-12-12.
- Patent 9079912, product 001; listed patent expiry date: 2026-12-12.
- Patent 9974790, product 001; listed patent expiry date: 2026-12-12.
- Patent 9974790, product 001; listed patent expiry date: 2026-12-12.
- Patent 10639310, product 001; listed patent expiry date: 2027-06-12.
- Patent 9079912, product 001; listed patent expiry date: 2027-06-12.
- Patent 9974790, product 001; listed patent expiry date: 2027-06-12.
- Patent 7598257, product 001; listed patent expiry date: 2027-12-24.
- Patent 8415362, product 001; listed patent expiry date: 2027-12-24.
- Patent 10610530, product 001; listed patent expiry date: 2028-06-12.
- Patent 10610530, product 001; listed patent expiry date: 2028-06-12.
- Patent 8722693, product 001; listed patent expiry date: 2028-06-12.
- Patent 8822481, product 001; listed patent expiry date: 2028-06-12.
- Patent 8822481, product 001; listed patent expiry date: 2028-06-12.
- Patent 7598257, product 001; listed patent expiry date: 2028-06-24.
- Patent 8415362, product 001; listed patent expiry date: 2028-06-24.
- Patent 10610530, product 001; listed patent expiry date: 2028-12-12.
- Patent 8722693, product 001; listed patent expiry date: 2028-12-12.
- Patent 8822481, product 001; listed patent expiry date: 2028-12-12.
- Patent 10758543, product 001; listed patent expiry date: 2031-05-20.
- Patent 10869870, product 001; listed patent expiry date: 2031-05-20.
- Patent 10869870, product 001; listed patent expiry date: 2031-05-20.
- Patent 11219624, product 001; listed patent expiry date: 2031-05-20.
- Patent 11571425, product 001; listed patent expiry date: 2031-05-20.
- Patent 11590136, product 001; listed patent expiry date: 2031-05-20.
- Patent 11590136, product 001; listed patent expiry date: 2031-05-20.
- Patent 12226419, product 001; listed patent expiry date: 2031-05-20.
- Patent 12544381, product 001; listed patent expiry date: 2031-05-20.
- Patent 12564593, product 001; listed patent expiry date: 2031-05-20.
- Patent 10758543, product 001; listed patent expiry date: 2031-11-20.
- Patent 10869870, product 001; listed patent expiry date: 2031-11-20.
- Patent 11219624, product 001; listed patent expiry date: 2031-11-20.
- Patent 11590138, product 001; listed patent expiry date: 2040-06-10.
- Patent 12233067, product 001; listed patent expiry date: 2040-07-28.
- Patent 11510923, product 001; listed patent expiry date: 2040-09-04.
- Patent 11590137, product 001; listed patent expiry date: 2040-09-04.
- Patent 12589096, product 001; listed patent expiry date: 2040-09-04.
- Patent 11602536, product 001; listed patent expiry date: 2041-05-05.
- Exclusivity I-896, product 001; listed exclusivity date: 2025-07-18.
- Exclusivity PED, product 001; listed exclusivity date: 2026-01-18.
- Exclusivity NPP, product 001; listed exclusivity date: 2028-09-18.

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

- RUXOLITINIB PHOSPHATE · UNII 436LRU32H5 · [lmmol compound JFMWPOCYMYGEDM-XFULWGLBSA-N](https://lmmol.com/compound/JFMWPOCYMYGEDM-XFULWGLBSA-N)

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/INCY/)
- [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:NDA215309. FDA data retrieved 2026-08-07.

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