Klisyri Patent Expiration

Klisyri is a drug owned by Almirall Llc. It is protected by 8 US drug patents filed from 2021 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 07, 2038. Details of Klisyri's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8236799 Biaryl compositions and methods for modulating a kinase cascade
Dec, 2025

(1 year, 5 months from now)

Active
US8980890 Compositions and methods of treating cell proliferation disorders
Dec, 2025

(1 year, 5 months from now)

Active
US7300931 Compositions for treating cell proliferation disorders
Feb, 2026

(1 year, 6 months from now)

Active
US7851470 Composition and methods for modulating a kinase cascade
Feb, 2029

(4 years from now)

Active
US10669236 Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide
Sep, 2038

(14 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10323001 Compositions for modulating a kinase cascade and methods of use thereof
Dec, 2027

(3 years from now)

Active
US10617693 Methods of treating and/or preventing actinic keratosis
Mar, 2038

(13 years from now)

Active
US11497750 Methods of treating and/or preventing actinic keratosis
Mar, 2038

(13 years from now)

Active


FDA has granted several exclusivities to Klisyri. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Klisyri, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Klisyri.

Exclusivity Information

Klisyri holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Klisyri's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 14, 2025

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US patents provide insights into the exclusivity only within the United States, but Klisyri is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Klisyri's family patents as well as insights into ongoing legal events on those patents.

Klisyri's family patents

Klisyri has patent protection in a total of 25 countries. It's US patent count contributes only to 39.1% of its total global patent coverage. Click below to unlock the full patent family tree for Klisyri.

Family Patents

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Generic Launch

Generic Release Date:

Klisyri's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 07, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Klisyri Generics:

There are no approved generic versions for Klisyri as of now.





About Klisyri

Klisyri is a drug owned by Almirall Llc. It is used for treating actinic keratosis on the face or scalp. Klisyri uses Tirbanibulin as an active ingredient. Klisyri was launched by Almirall in 2020.

Market Authorisation Date:

Klisyri was approved by FDA for market use on 14 December, 2020.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Klisyri is 14 December, 2020, its NCE-1 date is estimated to be 14 December, 2024

Active Ingredient:

Klisyri uses Tirbanibulin as the active ingredient. Check out other Drugs and Companies using Tirbanibulin ingredient

Treatment:

Klisyri is used for treating actinic keratosis on the face or scalp.

Dosage:

Klisyri is available in ointment form for topical use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
1% OINTMENT Prescription TOPICAL