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Generic Klisyri Availability

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

KLISYRI (tirbanibulin - ointment;topical)

  • Manufacturer: ALMIRALL
    Approval date: December 14, 2020
    Strength(s): 1% [RLD]

Has a generic version of Klisyri been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Klisyri. 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 FAQs.

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.

  • Compositions for modulating a kinase cascade and methods of use thereof
    Patent 10,323,001
    Issued: June 18, 2019
    Assignee(s): Athenex, Inc.

    The invention relates to compositions comprising 2-(5-(4-(2-morpholinoethoxy)phenyl) pyridin-2-yl)-N-benzylacetamide and its mesylate and dihydrochloride salts. The invention provides an efficient process for the synthesis of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide and its mesylate and dihydrochloride salts and methods for modulating one or more components of a kinase cascade using the compositions of the invention. The present invention also provides a novel polymorph of the mesylate salt of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide (Form A), characterized by a unique X-ray diffraction pattern and Differential Scanning Calorimetry profile, as well as a unique crystalline structure.

    Patent expiration dates:

    • December 28, 2027
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      Drug product
  • Patent 10,617,693

    Patent expiration dates:

    • March 12, 2038
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      Patent use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP
  • Patent 10,669,236

    Patent expiration dates:

    • September 7, 2038
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      Drug substance
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      Drug product
  • Compositions for treating cell proliferation disorders
    Patent 7,300,931
    Issued: November 27, 2007
    Inventor(s): Hangauer, Jr.; David G.
    Assignee(s): Kinex Pharmaceuticals, LLC

    The invention relates to compounds and methods for treating cell proliferation disorders.

    Patent expiration dates:

    • February 6, 2026
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      Drug substance
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      Drug product
  • Composition and methods for modulating a kinase cascade
    Patent 7,851,470
    Issued: December 14, 2010
    Inventor(s): Hangauer, Jr.; David G. & Coughlin; Daniel & Gale; Jonathan & Cody; Jeremy A. & Patra; Debasis
    Assignee(s): Kinex Pharmaceuticals, LLC

    The invention relates to compounds and methods for modulating one or more components of a kinase cascade.

    Patent expiration dates:

    • February 2, 2029
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      Patent use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP
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      Drug substance
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      Drug product
  • Biaryl compositions and methods for modulating a kinase cascade
    Patent 8,236,799
    Issued: August 7, 2012
    Inventor(s): Hangauer, Jr.; David G.
    Assignee(s): Kinex Pharmaceuticals, LLC

    The invention relates to compounds and methods for modulating one or more components of a kinase cascade. The invention relates to compounds of the formula I: or a pharmaceutically acceptable salt thereof. The compounds of the invention are useful for methods of protecting against or treating hearing loss, osteoporosis, cell proliferative disorders, obesity, diabetes, eye disease, stroke, atherosclerosis, neuropathic pain or hepatitis B.

    Patent expiration dates:

    • December 28, 2025
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      Drug substance
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      Drug product
  • Compositions and methods of treating cell proliferation disorders
    Patent 8,980,890
    Issued: March 17, 2015
    Assignee(s): Kinex Pharmaceuticals, LLC

    The invention relates to compounds and methods for treating cell proliferation disorders.

    Patent expiration dates:

    • December 28, 2025
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      Drug substance
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      Drug product

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:

    • December 14, 2025 - NEW CHEMICAL ENTITY

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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.