Generic Jakafi Availability

Last updated on Apr 10, 2025.

Jakafi is a brand name of ruxolitinib, approved by the FDA in the following formulation(s):

JAKAFI (ruxolitinib phosphate - tablet;oral)

Manufacturer: INCYTE CORP
Approval date: November 16, 2011
Strength(s): EQ 5MG BASE ^[RLD], EQ 10MG BASE ^[RLD], EQ 15MG BASE ^[RLD], EQ 20MG BASE ^[RLD], EQ 25MG BASE ^[RLD]

Is there a generic version of Jakafi available?

No. There is currently no therapeutically equivalent version of Jakafi available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Jakafi. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent 10,016,429
Issued: July 10, 2018
Inventor(s): Rodgers; James D. et al.
Assignee(s): INCYTE CORPORATION (Wilmington, DE); INCYTE HOLDINGS CORPORATION (Wilmington, DE)
The present invention provides salt forms of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile that are useful in the modulation of Janus kinase activity and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- June 12, 2028
  ✓
  Patent use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
- June 12, 2028
  ✓
  Patent use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent 10016429*PE
Issued: July 10, 2018
Inventor(s): Rodgers; James D. et al.
Assignee(s): INCYTE CORPORATION (Wilmington, DE); INCYTE HOLDINGS CORPORATION (Wilmington, DE)
The present invention provides salt forms of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile that are useful in the modulation of Janus kinase activity and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- December 12, 2028
Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Patent 7,598,257
Issued: October 6, 2009
Inventor(s): Rodgers; James D. et al.
Assignee(s): Incyte Corporation (Wilmington, DE)
The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines that modulate the activity of Janus kinases and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- December 24, 2027
  ✓
  Patent use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
  ✓
  Drug substance
  ✓
  Drug product
- December 24, 2027
  ✓
  Patent use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
  ✓
  Drug substance
  ✓
  Drug product
Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Patent 7598257*PED
Issued: October 6, 2009
Inventor(s): Rodgers; James D. et al.
Assignee(s): Incyte Corporation (Wilmington, DE)
The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines that modulate the activity of Janus kinases and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- June 24, 2028
  ✓
  Pediatric exclusivity
Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Patent 8,415,362
Issued: April 9, 2013
Inventor(s): Rodgers James D. & Shepard Stacey & Maduskuie Thomas P. & Wang Haisheng & Falahatpisheh Nikoo & Rafalski Maria & Arvanitis Argyrios G. & Storace Louis & Jalluri Ravi Kumar
Assignee(s): Incyte Corporation
The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines of Formula I:
Patent expiration dates:
- December 24, 2027
  ✓
  Drug substance
  ✓
  Drug product
Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Patent 8415362*PED
Issued: April 9, 2013
Inventor(s): Rodgers James D. & Shepard Stacey & Maduskuie Thomas P. & Wang Haisheng & Falahatpisheh Nikoo & Rafalski Maria & Arvanitis Argyrios G. & Storace Louis & Jalluri Ravi Kumar
Assignee(s): Incyte Corporation
The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines of Formula I:
Patent expiration dates:
- June 24, 2028
  ✓
  Pediatric exclusivity
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent 8,722,693
Issued: May 13, 2014
Inventor(s): Rodgers James D. & Li Hui-Yin
Assignee(s): Incyte Corporation
The present invention provides salt forms of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile that are useful in the modulation of Janus kinase activity and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- June 12, 2028
  ✓
  Drug substance
  ✓
  Drug product
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent 8722693*PED
Issued: May 13, 2014
Inventor(s): Rodgers James D. & Li Hui-Yin
Assignee(s): Incyte Corporation
The present invention provides salt forms of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile that are useful in the modulation of Janus kinase activity and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- December 12, 2028
  ✓
  Pediatric exclusivity
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent 8,822,481
Issued: September 2, 2014
Inventor(s): Rodgers James D. & Li Hui-Yin
Assignee(s): Incyte Corporation
The present invention provides salt forms of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile that are useful in the modulation of Janus kinase activity and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- June 12, 2028
  ✓
  Patent use: USE OF RUXOLITINIB (JAKAFI) FOR INHIBITING JANUS ASSOCIATED KINASES (JAKS) JAK1 AND/OR JAK2.
- June 12, 2028
  ✓
  Patent use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
- June 12, 2028
  ✓
  Patent use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
- June 12, 2028
  ✓
  Patent use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
- June 12, 2028
  ✓
  Patent use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent 8822481*PED
Issued: September 2, 2014
Inventor(s): Rodgers James D. & Li Hui-Yin
Assignee(s): Incyte Corporation
The present invention provides salt forms of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile that are useful in the modulation of Janus kinase activity and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- December 12, 2028
  ✓
  Pediatric exclusivity
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent 8,829,013
Issued: September 9, 2014
Inventor(s): Rodgers James D. & Li Hui-Yin
Assignee(s): Incyte Corporation
The present invention provides salt forms of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile that are useful in the modulation of Janus kinase activity and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- June 12, 2028
  ✓
  Patent use: FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS
- June 12, 2028
  ✓
  Patent use: FOR THE TREATMENT OF POLYCYTHEMIA VERA
- June 12, 2028
  ✓
  Patent use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
- June 12, 2028
  ✓
  Patent use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent 8829013*PED
Issued: September 9, 2014
Inventor(s): Rodgers James D. & Li Hui-Yin
Assignee(s): Incyte Corporation
The present invention provides salt forms of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile that are useful in the modulation of Janus kinase activity and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- December 12, 2028
  ✓
  Pediatric exclusivity
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent 9,079,912
Issued: July 14, 2015
Inventor(s): Rodgers James D. & Shepard Stacey
Assignee(s): Incyte Corporation
The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines that modulate the activity of Janus kinases and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- December 12, 2026
  ✓
  Patent use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
- December 12, 2026
  ✓
  Patent use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF
- December 12, 2026
  ✓
  Patent use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
- December 12, 2026
  ✓
  Patent use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent 9079912*PED
Issued: July 14, 2015
Inventor(s): Rodgers James D. & Shepard Stacey
Assignee(s): Incyte Corporation
The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines that modulate the activity of Janus kinases and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- June 12, 2027
  ✓
  Pediatric exclusivity
Heteroaryl substituted pyrrolo[2,3-b] pyridines and pyrrolo[2,3-b] pyrimidines as Janus kinase inhibitors
Patent 9,814,722
Issued: November 14, 2017
Inventor(s): Rodgers; James D. et al.
Assignee(s): Incyte Holdings Corporation (Wilmington, DE); Incyte Corporation (Wilmington, DE)
The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines that modulate the activity of Janus kinases and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- December 12, 2026
  ✓
  Patent use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY
- December 12, 2026
  ✓
  Patent use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)
Heteroaryl substituted pyrrolo[2,3-b] pyridines and pyrrolo[2,3-b] pyrimidines as Janus kinase inhibitors
Patent 9814722*PED
Issued: November 14, 2017
Inventor(s): Rodgers; James D. et al.
Assignee(s): Incyte Holdings Corporation (Wilmington, DE); Incyte Corporation (Wilmington, DE)
The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines that modulate the activity of Janus kinases and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.
Patent expiration dates:
- June 12, 2027
  ✓
  Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- September 22, 2024 - ADDITION OF THE INDICATION OF TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
- March 22, 2025 - PEDIATRIC EXCLUSIVITY
- December 19, 2025 - REVISIONS TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULTS OF STUDY INCB 18424-269
- May 24, 2026 - TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
- June 19, 2026 - PEDIATRIC EXCLUSIVITY
- November 24, 2026 - PEDIATRIC EXCLUSIVITY
- September 22, 2028 - TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
- March 22, 2029 - PEDIATRIC EXCLUSIVITY

More about Jakafi (ruxolitinib)

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Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

7.5 / 10

33 Reviews

Images

Pill INCY 10 is Jakafi 10 mg — Jakafi 10 mg (INCY 10)