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Last Updated: October 1, 2022

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 seven patents protecting this drug.

This drug has ninety-nine patent family members in twenty-five 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:99
US Patents:7
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 54
Patent Applications: 140
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 Generic Entry Opportunity 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.

US Patents and Regulatory Information for KLISYRI

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KLISYRI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating and/or preventing actinic keratosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions for treating cell proliferation disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Composition and methods for modulating a kinase cascade
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP

Biaryl compositions and methods for modulating a kinase cascade
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and methods of treating cell proliferation disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting KLISYRI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 2020004419
Estimated Expiration: See Plans and Pricing

Canada

Patent: 74831
Estimated Expiration: See Plans and Pricing

China

Patent: 1278808
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 79016
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2992
Estimated Expiration: See Plans and Pricing

Japan

Patent: 20533412
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 20112539
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 202001868R
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 200081359
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1920160
Estimated Expiration: See Plans and Pricing

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
Israel 242374 תרכובות ביאריל ותכשירי רוקחות המכילים אותן (Biaryl compounds and pharmacetutical compositions containing the same) See Plans and Pricing
European Patent Office 1836169 COMPOSITIONS ET PROCÉDÉS DE TRAITEMENT DE TROUBLES IMPLIQUANT UNE PROLIFÉRATION CELLULAIRE (COMPOSITIONS AND METHODS OF TREATING CELL PROLIFERATION DISORDERS) See Plans and Pricing
South Korea 101328273 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2008127728 See Plans and Pricing
China 101184734 Compositions and methods of treating cell proliferation disorders See Plans and Pricing
China 103274961 Compositions and methods of treating cell proliferation disorders See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KLISYRI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1836169 301145 Netherlands See Plans and Pricing PRODUCT NAME: TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210719
1836169 C01836169/01 Switzerland See Plans and Pricing PRODUCT NAME: TIRBANIBULIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68322 03.02.2022
1836169 49/2021 Austria See Plans and Pricing PRODUCT NAME: TIRBANIBULIN ODER EIN SALZ, SOLVAT ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/21/1558 (MITTEILUNG) 20210719
1836169 LUC00235 Luxembourg See Plans and Pricing PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:
1836169 2021C/001 Belgium See Plans and Pricing PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE: EU/1/21/1558 20210719
1836169 122021000066 Germany See Plans and Pricing PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716
>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.