Generic Zoryve Availability
Last updated on May 9, 2024.
Zoryve is a brand name of roflumilast topical, approved by the FDA in the following formulation(s):
ZORYVE (roflumilast - cream;topical)
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Manufacturer: ARCUTIS
Approval date: July 29, 2022
Strength(s): 0.3% [RLD]
ZORYVE (roflumilast - foam;topical)
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Manufacturer: ARCUTIS
Approval date: December 15, 2023
Strength(s): 0.3% [RLD]
Has a generic version of Zoryve been approved?
No. There is currently no therapeutically equivalent version of Zoryve available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zoryve. 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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Patent 10,940,142
Patent expiration dates:
- June 7, 2037✓
- June 7, 2037
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Topical roflumilast formulation having improved delivery and plasma half life
Patent 11,129,818
Issued: September 28, 2021
Inventor(s): Osborne David W. & Chaudhuri Bhaskar & Thurston & Jr. Archie W.
Assignee(s): Arcutis Biotherapeutics, Inc.The present invention is directed to methods for improving the therapeutic outcome of treatment with roflumilast. The therapeutic outcome is improved by consistent delivery and/or a longer plasma half-life of a topically administered roflumilast composition. The roflumilast composition preferably includes dicetyl phosphate, ceteth-10 phosphate, diethylene glycol monoethyl ether, and/or hexylene glycol.
Patent expiration dates:
- August 25, 2037✓
- August 25, 2037✓
- August 25, 2037✓
- August 25, 2037
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Patent 11,707,454
Patent expiration dates:
- December 3, 2041✓
- December 3, 2041
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Patent 11,793,796
Patent expiration dates:
- June 7, 2037✓
- June 7, 2037
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Patent 11,819,496
Patent expiration dates:
- June 7, 2037✓
- June 7, 2037✓
- June 7, 2037
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Inhibition of crystal growth of roflumilast
Patent 9,884,050
Issued: February 6, 2018
Inventor(s): Osborne David W.
Assignee(s): Arcutis, Inc.Roflumilast crystals have been shown to increase in size during storage. The size of the roflumilast crystals can affect the bioavailability and efficacy of a pharmaceutical composition. The growth of roflumilast crystals can be inhibited during storage by including hexylene glycol in the composition. The resulting composition has improved bioavailability and efficacy and can be used to inhibit phosphodiesterase 4 in a patient in need of such treatment.
Patent expiration dates:
- June 7, 2037✓
- June 7, 2037
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Inhibition of crystal growth of roflumilast
Patent 9,907,788
Issued: March 6, 2018
Inventor(s): Osborne David W.
Assignee(s): Arcutis Inc.Roflumilast crystals have been shown to increase in size during storage. The size of the roflumilast crystals can affect the bioavailability and efficacy of a pharmaceutical composition. The growth of roflumilast crystals can be inhibited during storage by including hexylene glycol in the composition. The resulting composition has improved bioavailability and efficacy and can be used to inhibit phosphodiesterase 4 in a patient in need of such treatment.
Patent expiration dates:
- June 7, 2037✓
- June 7, 2037✓
- June 7, 2037✓
- June 7, 2037
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:
- July 29, 2025 - NEW PRODUCT
- October 5, 2026 - NEW PATIENT POPULATION
- December 15, 2026 - NEW PRODUCT
More about Zoryve (roflumilast topical)
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- Drug class: selective phosphodiesterase-4 inhibitors
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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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.