FDA Orange Book
Is there a generic for Jakafi XR?
Jakafi XR 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 Jakafi XR (ruxolitinib). The Orange Book shows its last listed patent expires July 17, 2034 and its last listed exclusivity ends March 22, 2029.
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Jakafi XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 11MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 22MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 33MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 44MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 55MG BASE | Marketed (Rx) | None | 0 | None |
NDA 217180, held by INCYTE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Jakafi XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9814722 | December 12, 2026 | Method of use | U-3226 | 217180 |
| 9814722 | December 12, 2026 | Method of use | U-3230 | 217180 |
| 9206187 | December 12, 2026 | Method of use | U-3227 | 217180 |
| 9206187 | December 12, 2026 | Method of use | U-3228 | 217180 |
| 9079912 | December 12, 2026 | Method of use | U-3227 | 217180 |
| 9079912 | December 12, 2026 | Method of use | U-3228 | 217180 |
| 9079912 | December 12, 2026 | Method of use | U-3230 | 217180 |
| 9079912 | December 12, 2026 | Method of use | U-3226 | 217180 |
| 11744832 | December 12, 2026 | Method of use | U-3226 | 217180 |
| 11744832 | December 12, 2026 | Method of use | U-3230 | 217180 |
| 8530485 | December 12, 2026 | Drug product | None | 217180 |
| 7598257 | December 24, 2027 | Drug substance, Drug product | U-3227 | 217180 |
| 7598257 | December 24, 2027 | Drug substance, Drug product | U-3228 | 217180 |
| 8415362 | December 24, 2027 | Drug substance, Drug product | None | 217180 |
| 8829013 | June 12, 2028 | Method of use | U-3227 | 217180 |
| 8829013 | June 12, 2028 | Method of use | U-3228 | 217180 |
| 10016429 | June 12, 2028 | Method of use | U-3226 | 217180 |
| 10016429 | June 12, 2028 | Method of use | U-3230 | 217180 |
| 8822481 | June 12, 2028 | Method of use | U-3227 | 217180 |
| 8822481 | June 12, 2028 | Method of use | U-3228 | 217180 |
| 8822481 | June 12, 2028 | Method of use | U-3230 | 217180 |
| 8822481 | June 12, 2028 | Method of use | U-3226 | 217180 |
| 8722693 | June 12, 2028 | Drug substance, Drug product | None | 217180 |
| 11213528 | June 12, 2028 | Drug product | None | 217180 |
| 8415362*PED | June 24, 2028 | Method of use | None | 217180 |
| 7598257*PED | June 24, 2028 | Method of use | None | 217180 |
| 8829013*PED | December 12, 2028 | Method of use | None | 217180 |
| 10016429*PED | December 12, 2028 | Method of use | None | 217180 |
| 8822481*PED | December 12, 2028 | Method of use | None | 217180 |
| 11213528*PED | December 12, 2028 | Method of use | None | 217180 |
| 8722693*PED | December 12, 2028 | Method of use | None | 217180 |
| 11576864 | November 14, 2033 | Method of use | U-3227 | 217180 |
| 11576864 | November 14, 2033 | Method of use | U-3228 | 217180 |
| 11576864 | November 14, 2033 | Method of use | U-3230 | 217180 |
| 11576864 | November 14, 2033 | Method of use | U-3226 | 217180 |
| 11896717 | November 14, 2033 | Drug product | U-3227 | 217180 |
| 11896717 | November 14, 2033 | Drug product | U-3228 | 217180 |
| 11896717 | November 14, 2033 | Drug product | U-3230 | 217180 |
| 11896717 | November 14, 2033 | Drug product | U-3226 | 217180 |
| 11576865 | November 14, 2033 | Drug product | U-3227 | 217180 |
| 11576865 | November 14, 2033 | Drug product | U-3228 | 217180 |
| 11576865 | November 14, 2033 | Drug product | U-3230 | 217180 |
| 11576865 | November 14, 2033 | Drug product | U-3226 | 217180 |
| 10874616 | November 14, 2033 | Drug product | None | 217180 |
| 11337927 | January 17, 2034 | Method of use | U-3227 | 217180 |
| 11337927 | January 17, 2034 | Method of use | U-3228 | 217180 |
| 11337927 | January 17, 2034 | Method of use | U-3230 | 217180 |
| 11337927 | January 17, 2034 | Method of use | U-3226 | 217180 |
| 10874616*PED | May 14, 2034 | Method of use | None | 217180 |
| 11576864*PED | May 14, 2034 | Method of use | None | 217180 |
| 11896717*PED | May 14, 2034 | Method of use | None | 217180 |
| 11576865*PED | May 14, 2034 | Method of use | None | 217180 |
| 11337927*PED | July 17, 2034 | Method of use | None | 217180 |
Jakafi XR exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE* | See the Orange Book exclusivity code list | September 22, 2028 | 217180 |
| PED | Pediatric exclusivity | March 22, 2029 | 217180 |
Jakafi XR NDC codes
Questions
Is there a generic for Jakafi XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Jakafi XR (ruxolitinib). The Orange Book shows its last listed patent expires July 17, 2034 and its last listed exclusivity ends March 22, 2029.
What is the generic name for Jakafi XR?
The active ingredient in Jakafi XR is ruxolitinib, per the FDA Orange Book.
When does the Jakafi XR patent expire?
The last patent listed for Jakafi XR in the Orange Book expires July 17, 2034. 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.