Generic Klisyri Availability
Last updated on May 7, 2025.
Klisyri is a brand name of tirbanibulin topical, approved by the FDA in the following formulation(s):
KLISYRI (tirbanibulin - ointment;topical)
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Manufacturer: ALMIRALL
Approval date: December 14, 2020
Strength(s): 1% [RLD]
Is there a generic version of Klisyri available?
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 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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Compositions for modulating a kinase cascade and methods of use thereof
Patent 10,323,001
Issued: June 18, 2019
Inventor(s): Hangauer & Jr. David G. & Patra Debasis & Cody Jeremy A. & Palmer Grant J. & Isbester Paul K. & Salsbury Jonathon
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✓
- December 28, 2027
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Methods of treating and/or preventing actinic keratosis
Patent 10,617,693
Issued: April 14, 2020
Inventor(s): Kwan Min-Fun Rudolf & Lau Johnson Yiu-Nam & Kramer E. Douglas & Cutler David Lawrence & Fang Jane
Assignee(s): Athenex, Inc.The application pertains to methods of treating and/or preventing actinic keratosis, comprising administering a therapeutically effective amount of KX-01,
Patent expiration dates:
- March 12, 2038✓
- March 12, 2038
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Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide
Patent 10,669,236
Issued: June 2, 2020
Inventor(s): Smolinski Michael P.
Assignee(s): Athenex HK Innovative LimitedThe present application provides solid Forms A, B, and C of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide, and methods of preparing and using same. The compounds disclosed herein may be used in the treatment or prevention of a disease or condition in which a tyrosine kinase plays a role.
Patent expiration dates:
- September 7, 2038✓✓
- September 7, 2038
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Methods of treating and/or preventing actinic keratosis
Patent 11,497,750
Issued: November 15, 2022
Inventor(s): Kwan; Min-Fun Rudolf et al.
Assignee(s): ATNX SPV, LLC (Buffalo, NY)The application pertains to methods of treating and/or preventing actinic keratosis, comprising administering a therapeutically effective amount of KX-01, ##STR00001##
to a subject in need thereof.Patent expiration dates:
- March 12, 2038✓
- March 12, 2038
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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 (Buffalo, NY)The invention relates to compounds and methods for treating cell proliferation disorders.
Patent expiration dates:
- February 6, 2026✓✓
- February 6, 2026
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Composition and methods for modulating a kinase cascade
Patent 7,851,470
Issued: December 14, 2010
Inventor(s): Hangauer, Jr.; David G. et al.
Assignee(s): Kinex Pharmaceuticals, LLC (Buffalo, NY)The invention relates to compounds and methods for modulating one or more components of a kinase cascade.
Patent expiration dates:
- February 2, 2029✓✓✓
- February 2, 2029
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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, LLCThe 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:
Patent expiration dates:
- December 28, 2025✓✓
- December 28, 2025
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Compositions and methods of treating cell proliferation disorders
Patent 8,980,890
Issued: March 17, 2015
Inventor(s): Hangauer & Jr. David G.
Assignee(s): Kinex Pharmaceuticals, LLCThe invention relates to compounds and methods for treating cell proliferation disorders.
Patent expiration dates:
- December 28, 2025✓✓
- December 28, 2025
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
- June 7, 2027 - EXPANSION OF THE TREATMENT FIELD ON THE FACE OR SCALP UP TO 100 CM^2
More about Klisyri (tirbanibulin topical)
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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.
