FDA Orange Book
Is there a generic for Jakafi?
Jakafi 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 (ruxolitinib). The Orange Book shows its last listed patent expires December 12, 2028 and its last listed exclusivity ends March 22, 2029.
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Jakafi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 15MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 202192, 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 patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9079912 | December 12, 2026 | Method of use | U-3226 | 202192 |
| 9079912 | December 12, 2026 | Method of use | U-3228 | 202192 |
| 9079912 | December 12, 2026 | Method of use | U-3227 | 202192 |
| 9814722 | December 12, 2026 | Method of use | U-3226 | 202192 |
| 9079912 | December 12, 2026 | Method of use | U-3230 | 202192 |
| 9814722 | December 12, 2026 | Method of use | U-3230 | 202192 |
| 9079912*PED | June 12, 2027 | Method of use | None | 202192 |
| 9814722*PED | June 12, 2027 | Method of use | None | 202192 |
| 7598257 | December 24, 2027 | Drug substance, Drug product | U-3228 | 202192 |
| 7598257 | December 24, 2027 | Drug substance, Drug product | U-3227 | 202192 |
| 8415362 | December 24, 2027 | Drug substance, Drug product | None | 202192 |
| 8822481 | June 12, 2028 | Method of use | U-1573 | 202192 |
| 8829013 | June 12, 2028 | Method of use | U-1622 | 202192 |
| 8829013 | June 12, 2028 | Method of use | U-1201 | 202192 |
| 8822481 | June 12, 2028 | Method of use | U-3226 | 202192 |
| 8822481 | June 12, 2028 | Method of use | U-3228 | 202192 |
| 8822481 | June 12, 2028 | Method of use | U-3227 | 202192 |
| 10016429 | June 12, 2028 | Method of use | U-3226 | 202192 |
| 8829013 | June 12, 2028 | Method of use | U-3227 | 202192 |
| 8829013 | June 12, 2028 | Method of use | U-3228 | 202192 |
| 10016429 | June 12, 2028 | Method of use | U-3230 | 202192 |
| 8822481 | June 12, 2028 | Method of use | U-3230 | 202192 |
| 8722693 | June 12, 2028 | Drug substance, Drug product | None | 202192 |
| 7598257*PED | June 24, 2028 | Method of use | None | 202192 |
| 8415362*PED | June 24, 2028 | Method of use | None | 202192 |
| 8722693*PED | December 12, 2028 | Method of use | None | 202192 |
| 8822481*PED | December 12, 2028 | Method of use | None | 202192 |
| 8829013*PED | December 12, 2028 | Method of use | None | 202192 |
| 10016429*PED | December 12, 2028 | Method of use | None | 202192 |
Jakafi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-285 | Miscellaneous | December 19, 2025 | 202192 |
| ODE-238 | Orphan drug exclusivity | May 24, 2026 | 202192 |
| PED | Pediatric exclusivity | June 19, 2026 | 202192 |
| PED | Pediatric exclusivity | November 24, 2026 | 202192 |
| ODE-373 | Orphan drug exclusivity | September 22, 2028 | 202192 |
| PED | Pediatric exclusivity | March 22, 2029 | 202192 |
Jakafi NDC codes
Questions
Is there a generic for Jakafi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Jakafi (ruxolitinib). The Orange Book shows its last listed patent expires December 12, 2028 and its last listed exclusivity ends March 22, 2029.
What is the generic name for Jakafi?
The active ingredient in Jakafi is ruxolitinib, per the FDA Orange Book.
When does the Jakafi patent expire?
The last patent listed for Jakafi in the Orange Book expires December 12, 2028. 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 Jakafi and Ruxolitinib
- What is Jakafi used for?FDA label uses
- Is Jakafi a controlled substance?Federal schedule
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- Janus Kinase Inhibitors listFDA drug class
- Kinase Inhibitors listFDA drug class
- Jakafi Medicare Part D coverageBy plan and state
- NDC 50881-005Jakafi NDC record
- NDC 50881-010Jakafi NDC record
- NDC 50881-015Jakafi NDC record