Tirbanibulin Patent Expiration

Tirbanibulin is Used for treating actinic keratosis on the face or scalp. It was first introduced by Almirall Llc in its drug Klisyri on Dec 14, 2020.


Tirbanibulin Patents

Given below is the list of patents protecting Tirbanibulin, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Klisyri US10669236 Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide Sep 07, 2038 Almirall
Klisyri US10617693 Methods of treating and/or preventing actinic keratosis Mar 12, 2038 Almirall
Klisyri US11497750 Methods of treating and/or preventing actinic keratosis Mar 12, 2038 Almirall
Klisyri US12667576 Methods Of Treating And/Or Preventing Actinic Keratosis Mar 12, 2038 Almirall
Klisyri US7300931 Compositions for treating cell proliferation disorders Dec 28, 2030 Almirall
Klisyri US7851470 Composition and methods for modulating a kinase cascade Feb 02, 2029 Almirall
Klisyri US10323001 Compositions for modulating a kinase cascade and methods of use thereof Dec 28, 2027 Almirall
Klisyri US8236799 Biaryl compositions and methods for modulating a kinase cascade Dec 28, 2025

(Expired)

Almirall
Klisyri US8980890 Compositions and methods of treating cell proliferation disorders Dec 28, 2025

(Expired)

Almirall



Tirbanibulin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Tirbanibulin:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Efficacy and Safety of Cryotherapy Followed by Tirbanibulin Ointment for Actinic Keratosis on the Scalp and Forehead University Hospital, Lille NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis Almirall, S.A. NA COMPLETED
(Mar 1, 2026)
PHASE3


Tirbanibulin Generic API Manufacturers

Given below is the list of companies who have filed for Tirbanibulin generic, along with the locations of their manufacturing plants worldwide.