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Generic Opzelura Availability

Last updated on Nov 8, 2022.

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

OPZELURA (ruxolitinib phosphate - cream;topical)

  • Manufacturer: INCYTE CORP
    Approval date: September 21, 2021
    Strength(s): EQ 1.5% BASE [RLD]

Has a generic version of Opzelura been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Opzelura. 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: Generic Drug FAQ.

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.

  • Patent 10,610,530

    Patent expiration dates:

    • June 12, 2028
      ✓ 
      Patent use: FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
    • June 12, 2028
      ✓ 
      Patent use: FOR TOPICAL SHORT-TERM, NON-CONTINUOUS CHRONIC TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN NON-IMMUNOCOMPROMISED PATIENTS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH TOPICAL PRESCRIPTION THERAPIES OR WHEN THOSE THERAPIES ARE NOT ADVISABLE
  • Patent 10,639,310

    Patent expiration dates:

    • December 12, 2026
      ✓ 
      Patent use: FOR TOPICAL SHORT-TERM, NON-CONTINUOUS CHRONIC TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN NON-IMMUNOCOMPROMISED PATIENTS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH TOPICAL PRESCRIPTION THERAPIES OR WHEN THOSE THERAPIES ARE NOT ADVISABLE
  • Patent 10,758,543

    Patent expiration dates:

    • May 20, 2031
      ✓ 
      Drug product
  • Patent 10,869,870

    Patent expiration dates:

    • May 20, 2031
      ✓ 
      Patent use: FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
    • May 20, 2031
      ✓ 
      Patent use: FOR TOPICAL SHORT-TERM, NON-CONTINUOUS CHRONIC TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN NON-IMMUNOCOMPROMISED PATIENTS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH TOPICAL PRESCRIPTION THERAPIES OR WHEN THOSE THERAPIES ARE NOT ADVISABLE
  • Patent 11,219,624

    Patent expiration dates:

    • May 20, 2031
      ✓ 
      Patent use: FOR TOPICAL SHORT-TERM, NON-CONTINUOUS CHRONIC TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN NON-IMMUNOCOMPROMISED PATIENTS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH TOPICAL PRESCRIPTION THERAPIES OR WHEN THOSE THERAPIES ARE NOT ADVISABLE
      ✓ 
      Drug product
  • 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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      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
      ✓ 
      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 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
      ✓ 
      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 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
      ✓ 
      Patent use: FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
    • June 12, 2028
      ✓ 
      Patent use: FOR TOPICAL SHORT-TERM, NON-CONTINUOUS CHRONIC TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN NON-IMMUNOCOMPROMISED PATIENTS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH TOPICAL PRESCRIPTION THERAPIES OR WHEN THOSE THERAPIES ARE NOT ADVISABLE
  • 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
      ✓ 
      Patent use: FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
    • December 12, 2026
      ✓ 
      Patent use: FOR TOPICAL SHORT-TERM, NON-CONTINUOUS CHRONIC TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN NON-IMMUNOCOMPROMISED PATIENTS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH TOPICAL PRESCRIPTION THERAPIES OR WHEN THOSE THERAPIES ARE NOT ADVISABLE
  • Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
    Patent 9,974,790
    Issued: May 22, 2018
    Assignee(s): Incyte Corporation Incyte Holdings 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 THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
    • December 12, 2026
      ✓ 
      Patent use: FOR TOPICAL SHORT-TERM, NON-CONTINUOUS CHRONIC TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS IN NON-IMMUNOCOMPROMISED PATIENTS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH TOPICAL PRESCRIPTION THERAPIES OR WHEN THOSE THERAPIES ARE NOT ADVISABLE

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 21, 2024 - NEW PRODUCT
    • July 18, 2025 - INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

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.