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Generic Jakafi Availability

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, EQ 10MG BASE, EQ 15MG BASE, EQ 20MG BASE, EQ 25MG BASE [RLD]

Has a generic version of Jakafi been approved?

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.

See also: About generic drugs.

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.

  • 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. & 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 24, 2027
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      Patent use: FOR THE TREATMENT OF POLYCYTHEMIA VERA
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      Drug substance
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      Drug product
    • December 24, 2027
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      Patent use: FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS
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      Drug substance
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      Drug product
  • Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
    Patent 8,415,362
    Issued: April 9, 2013
    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: 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
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      Drug substance
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      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 8,722,693
    Issued: May 13, 2014
    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
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      Drug substance
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      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 8,822,481
    Issued: September 2, 2014
    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
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      Patent use: USE OF RUXOLITINIB (JAKAFI) FOR INHIBITING JANUS ASSOCIATED KINASES (JAKS) JAK1 AND/OR JAK2.
  • 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
    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 POLYCYTHEMIA VERA
    • June 12, 2028
      ✓ 
      Patent use: FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS
  • 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
    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
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      Patent use: USE OF RUXOLITINIB (JAKAFI) FOR INHIBITING JANUS ASSOCIATED KINASES (JAKS) JAK1 AND/OR JAK2.
    • December 12, 2026
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      Patent use: USE OF RUXOLITINIB (JAKAFI) FOR BLOCKING SIGNAL TRANSDUCTION OF JANUS ASSOCIATED KINASES (JAKS) JAK1 AND/OR JAK2

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:
    • November 16, 2016 - NEW CHEMICAL ENTITY
    • December 4, 2017 - FOR TREATMENT OF PATIENTS WITH POLYCYTHEMIA VERA WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
    • November 16, 2018 - ORPHAN DRUG EXCLUSIVITY
    • December 4, 2021 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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