Generic Opzelura Availability
Last updated on Nov 6, 2024.
Opzelura is a brand name of ruxolitinib topical, approved by the FDA in the following formulation(s):
OPZELURA (ruxolitinib phosphate - cream;topical)
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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.
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Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent 10,610,530
Issued: April 7, 2020
Inventor(s): Li Hui-Yin & Rodgers James D.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✓
- June 12, 2028✓
- June 12, 2028
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Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent 10610530*PE
Issued: April 7, 2020
Inventor(s): Li Hui-Yin & Rodgers James D.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
- December 12, 2028
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Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Patent 10,639,310
Issued: May 5, 2020
Inventor(s): Rodgers James D. & Shepard Stacey
Assignee(s): Incyte CorporationThe 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✓
- December 12, 2026
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Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Patent 10639310*PE
Issued: May 5, 2020
Inventor(s): Rodgers James D. & Shepard Stacey
Assignee(s): Incyte CorporationThe 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
- June 12, 2027
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Topical formulation for a JAK inhibitor
Patent 10,758,543
Issued: September 1, 2020
Inventor(s): Parikh Bhavnish & Shah Bhavesh & Yeleswaram Krishnaswamy
Assignee(s): INCYTE CORPORATIONThis invention relates to pharmaceutical formulations for topical skin application comprising (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt thereof, and use in the treatment of skin disorders.
Patent expiration dates:
- May 20, 2031✓
- May 20, 2031
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Topical formulation for a JAK inhibitor
Patent 10758543*PE
Issued: September 1, 2020
Inventor(s): Parikh Bhavnish & Shah Bhavesh & Yeleswaram Krishnaswamy
Assignee(s): INCYTE CORPORATIONThis invention relates to pharmaceutical formulations for topical skin application comprising (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt thereof, and use in the treatment of skin disorders.
Patent expiration dates:
- November 20, 2031
- November 20, 2031
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Topical formulation for a JAK inhibitor
Patent 10,869,870
Issued: December 22, 2020
Inventor(s): Parikh Bhavnish & Shah Bhavesh & Yeleswaram Krishnaswamy
Assignee(s): Incyte CorporationThis invention relates to pharmaceutical formulations for topical skin application comprising (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt thereof, and use in the treatment of skin disorders.
Patent expiration dates:
- May 20, 2031✓
- May 20, 2031✓
- May 20, 2031
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Topical formulation for a JAK inhibitor
Patent 10869870*PE
Issued: December 22, 2020
Inventor(s): Parikh Bhavnish & Shah Bhavesh & Yeleswaram Krishnaswamy
Assignee(s): Incyte CorporationThis invention relates to pharmaceutical formulations for topical skin application comprising (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt thereof, and use in the treatment of skin disorders.
Patent expiration dates:
- November 20, 2031
- November 20, 2031
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Topical formulation for a JAK inhibitor
Patent 11,219,624
Issued: January 11, 2022
Inventor(s): Parikh Bhavnish & Shah Bhavesh & Yeleswaram Krishnaswamy
Assignee(s): INCYTE HOLDINGS CORPORATIONThis invention relates to pharmaceutical formulations for topical skin application comprising (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt thereof, and use in the treatment of skin disorders.
Patent expiration dates:
- May 20, 2031✓✓
- May 20, 2031
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Topical formulation for a JAK inhibitor
Patent 11219624*PE
Issued: January 11, 2022
Inventor(s): Parikh Bhavnish & Shah Bhavesh & Yeleswaram Krishnaswamy
Assignee(s): INCYTE HOLDINGS CORPORATIONThis invention relates to pharmaceutical formulations for topical skin application comprising (R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile, or a pharmaceutically acceptable salt thereof, and use in the treatment of skin disorders.
Patent expiration dates:
- November 20, 2031
- November 20, 2031
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Ruxolitinib formulation for reduction of itch in atopic dermatitis
Patent 11,510,923
Issued: November 29, 2022
Inventor(s): Kuligowski Michael & Sun Kang & Howell Michael & Venturanza May Grace E. & Lee Jim
Assignee(s): Incyte CorporationThis disclosure relates to methods of reducing itch in patients with atopic dermatitis and treating patients with atopic dermatitis by administering a topical 0.75% or 1.5% ruxolitinib cream two times per day.
Patent expiration dates:
- September 4, 2040✓
- September 4, 2040
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Patent 11,571,425
Patent expiration dates:
- May 20, 2031✓
- May 20, 2031
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Patent 11,590,136
Patent expiration dates:
- May 20, 2031✓
- May 20, 2031✓
- May 20, 2031
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Patent 11,590,137
Patent expiration dates:
- September 4, 2040✓
- September 4, 2040
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Patent 11,590,138
Patent expiration dates:
- June 10, 2040✓
- June 10, 2040
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Patent 11,602,536
Patent expiration dates:
- May 5, 2041✓
- May 5, 2041
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Patent 7,598,257
Patent expiration dates:
- December 24, 2027✓✓
- December 24, 2027
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Patent 7598257*PED
Patent expiration dates:
- June 24, 2028✓
- June 24, 2028
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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 CorporationThe 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✓✓
- December 24, 2027
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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 CorporationThe 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✓
- June 24, 2028
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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 CorporationThe 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✓✓
- June 12, 2028
-
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 CorporationThe 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✓
- December 12, 2028
-
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 CorporationThe 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✓
- June 12, 2028✓
- June 12, 2028
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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 CorporationThe 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✓
- December 12, 2028
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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 CorporationThe 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✓
- December 12, 2026✓
- December 12, 2026
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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 CorporationThe 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✓
- June 12, 2027
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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
Inventor(s): Rodgers James D. & Shepard StaceyThe 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✓
- December 12, 2026✓
- December 12, 2026
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Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Patent 9974790*PED
Issued: May 22, 2018
Inventor(s): Rodgers James D. & Shepard StaceyThe 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✓
- June 12, 2027
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
- March 21, 2025 - PEDIATRIC EXCLUSIVITY
- July 18, 2025 - INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
- January 18, 2026 - PEDIATRIC EXCLUSIVITY
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Glossary
Term | Definition |
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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
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