FDA Orange Book
Is there a generic for Opzelura?
Opzelura contains ruxolitinib. 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 Opzelura (ruxolitinib). The Orange Book shows its last listed patent expires May 5, 2041 and its last listed exclusivity ends September 18, 2028.
Run it in Rivvi
Map Opzelura and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Opzelura products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | EQ 1.5% BASE | Marketed (Rx) | None | 0 | None |
NDA 215309, held by INCYTE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Opzelura patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9079912 | December 12, 2026 | Method of use | U-3404 | 215309 |
| 9974790 | December 12, 2026 | Method of use | U-3404 | 215309 |
| 9079912 | December 12, 2026 | Method of use | U-3229 | 215309 |
| 9974790 | December 12, 2026 | Method of use | U-3229 | 215309 |
| 10639310 | December 12, 2026 | Method of use | U-3229 | 215309 |
| 9079912*PED | June 12, 2027 | Method of use | None | 215309 |
| 9974790*PED | June 12, 2027 | Method of use | None | 215309 |
| 10639310*PED | June 12, 2027 | Method of use | None | 215309 |
| 7598257 | December 24, 2027 | Drug substance, Drug product | None | 215309 |
| 8415362 | December 24, 2027 | Drug substance, Drug product | None | 215309 |
| 8822481 | June 12, 2028 | Method of use | U-3404 | 215309 |
| 10610530 | June 12, 2028 | Method of use | U-3404 | 215309 |
| 10610530 | June 12, 2028 | Method of use | U-3229 | 215309 |
| 8822481 | June 12, 2028 | Method of use | U-3229 | 215309 |
| 8722693 | June 12, 2028 | Drug substance, Drug product | None | 215309 |
| 7598257*PED | June 24, 2028 | Method of use | None | 215309 |
| 8415362*PED | June 24, 2028 | Method of use | None | 215309 |
| 8722693*PED | December 12, 2028 | Method of use | None | 215309 |
| 8822481*PED | December 12, 2028 | Method of use | None | 215309 |
| 10610530*PED | December 12, 2028 | Method of use | None | 215309 |
| 10869870 | May 20, 2031 | Method of use | U-3404 | 215309 |
| 11219624 | May 20, 2031 | Drug product | U-3229 | 215309 |
| 10869870 | May 20, 2031 | Method of use | U-3229 | 215309 |
| 11590136 | May 20, 2031 | Method of use | U-3229 | 215309 |
| 11590136 | May 20, 2031 | Method of use | U-3404 | 215309 |
| 12544381 | May 20, 2031 | Drug product | None | 215309 |
| 12564593 | May 20, 2031 | Drug product | None | 215309 |
| 10758543 | May 20, 2031 | Drug product | None | 215309 |
| 12226419 | May 20, 2031 | Drug product | None | 215309 |
| 11571425 | May 20, 2031 | Drug product | None | 215309 |
| 11219624*PED | November 20, 2031 | Method of use | None | 215309 |
| 10758543*PED | November 20, 2031 | Method of use | None | 215309 |
| 10869870*PED | November 20, 2031 | Method of use | None | 215309 |
| 11590138 | June 10, 2040 | Method of use | U-3551 | 215309 |
| 12233067 | July 28, 2040 | Method of use | U-4151 | 215309 |
| 11510923 | September 4, 2040 | Method of use | U-3505 | 215309 |
| 11590137 | September 4, 2040 | Method of use | U-3505 | 215309 |
| 12589096 | September 4, 2040 | Method of use | U-3505 | 215309 |
| 11602536 | May 5, 2041 | Method of use | U-3550 | 215309 |
Opzelura exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-896 | New indication | July 18, 2025 | 215309 |
| PED | Pediatric exclusivity | January 18, 2026 | 215309 |
| NPP | New patient population | September 18, 2028 | 215309 |
Opzelura NDC codes
Questions
Is there a generic for Opzelura?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Opzelura (ruxolitinib). The Orange Book shows its last listed patent expires May 5, 2041 and its last listed exclusivity ends September 18, 2028.
What is the generic name for Opzelura?
The active ingredient in Opzelura is ruxolitinib, per the FDA Orange Book.
When does the Opzelura patent expire?
The last patent listed for Opzelura in the Orange Book expires May 5, 2041. 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.
More on Opzelura and Ruxolitinib
- What is Opzelura used for?FDA label uses
- Is Opzelura a controlled substance?Federal schedule
- Generic for Jakafi XRFDA Orange Book
- Generic for JakafiFDA Orange Book
- Janus Kinase Inhibitors listFDA drug class
- Kinase Inhibitors listFDA drug class
- Opzelura Medicare Part D coverageBy plan and state
- NDC 50881-007Opzelura NDC record