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Last Updated: March 1, 2024

KLISYRI Drug Patent Profile


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When do Klisyri patents expire, and when can generic versions of Klisyri launch?

Klisyri is a drug marketed by Almirall and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and six patent family members in twenty-six countries.

The generic ingredient in KLISYRI is tirbanibulin. One supplier is listed for this compound. Additional details are available on the tirbanibulin profile page.

DrugPatentWatch® Generic Entry Outlook for Klisyri

Klisyri will be eligible for patent challenges on December 14, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 7, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for KLISYRI
International Patents:106
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 65
Patent Applications: 133
Drug Prices: Drug price information for KLISYRI
What excipients (inactive ingredients) are in KLISYRI?KLISYRI excipients list
DailyMed Link:KLISYRI at DailyMed
Drug patent expirations by year for KLISYRI
Drug Prices for KLISYRI

See drug prices for KLISYRI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KLISYRI
Generic Entry Date for KLISYRI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
OINTMENT;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for KLISYRI
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition

US Patents and Regulatory Information for KLISYRI

KLISYRI is protected by eight US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KLISYRI is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting KLISYRI

Compositions for modulating a kinase cascade and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods of treating and/or preventing actinic keratosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP

Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP

Compositions for treating cell proliferation disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Composition and methods for modulating a kinase cascade
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP

Biaryl compositions and methods for modulating a kinase cascade
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods of treating cell proliferation disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting KLISYRI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for KLISYRI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Almirall, S.A. Klisyri tirbanibulin EMEA/H/C/005183
Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.
Authorised no no no 2021-07-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for KLISYRI

When does loss-of-exclusivity occur for KLISYRI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 18330163
Estimated Expiration: ⤷  Try a Trial

Patent: 23201010
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2020004419
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 74831
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1278808
Patent: 2-(5-(4-(2-吗啉代乙氧基)苯基)吡啶-2-基)-N-苄基乙酰胺的固体形式 (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 79016
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2992
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 20533412
Estimated Expiration: ⤷  Try a Trial

Patent: 23157909
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 20002622
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 20112539
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 202001868R
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 200081359
Patent: 2--N-벤질아세트아미드의 고체 형태
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 15820
Estimated Expiration: ⤷  Try a Trial

Patent: 1920160
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KLISYRI around the world.

Country Patent Number Title Estimated Expiration
Japan 2010527361 ⤷  Try a Trial
Japan 2017193587 キナーゼカスケードを調節するための組成物の調製のための方法ならびにその使用方法 (METHOD FOR PREPARING COMPOSITIONS FOR MODULATING KINASE CASCADE, AND METHOD OF USING THE SAME) ⤷  Try a Trial
Russian Federation 2019131757 СПОСОБЫ ЛЕЧЕНИЯ И/ИЛИ ПРЕДОТВРАЩЕНИЯ АКТИНИЧЕСКОГО КЕРАТОЗА ⤷  Try a Trial
Taiwan I457336 ⤷  Try a Trial
Australia 2018330163 Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KLISYRI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1836169 122021000066 Germany ⤷  Try a Trial PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716
1836169 C01836169/01 Switzerland ⤷  Try a Trial FORMER OWNER: ATHENEX, INC., US
1836169 LUC00235 Luxembourg ⤷  Try a Trial PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:
1836169 C202130061 Spain ⤷  Try a Trial PRODUCT NAME: TIRBANIBULINA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1558; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1558; DATE OF FIRST AUTHORISATION IN EEA: 20210716
1836169 2021C/001 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.