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Last Updated: November 10, 2024

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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 eight 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:108
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 65
Patent Applications: 119
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 two FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods of treating and/or preventing actinic keratosis
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP

Compositions for treating cell proliferation disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Biaryl compositions and methods for modulating a kinase cascade
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions and methods of treating cell proliferation disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting KLISYRI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

EXPANSION OF THE TREATMENT FIELD ON THE FACE OR SCALP UP TO 100 CM^2
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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
Patent: Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide
Estimated Expiration: ⤷  Sign Up

Patent: 23201010
Patent: SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2020004419
Patent: formas sólidas de 2-(5-(4-(2-morfolinoetóxi)fenil)piridin-2-il)-n-benzilacetamida
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 74831
Patent: FORMES SOLIDES DE 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
Estimated Expiration: ⤷  Sign Up

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: ⤷  Sign Up

European Patent Office

Patent: 79016
Patent: FORMES SOLIDES DE 2-(5-(4-(2-MORPHOLINOÉTHOXY)PHÉNYL)PYRIDIN-2-YL)-N-BENZYLACÉTAMIDE (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2992
Patent: תצורות מוצקות של 2-(5-(4-(2-מורפולינואתוקסי)פניל)פירידין-2-איל)-n-בנזילאצטאמיד (Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-n-benzylacetamide)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 20533412
Patent: 2−(5−(4−(2−モルホリノエトキシ)フェニル)ピリジン−2−イル)−N−ベンジルアセトアミドの固体形態
Estimated Expiration: ⤷  Sign Up

Patent: 23157909
Patent: 2-(5-(4-(2-モルホリノエトキシ)フェニル)ピリジン-2-イル)-N-ベンジルアセトアミドの固体形態 (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 20002622
Patent: FORMAS SOLIDAS DE 2-(5-(4-(2-MORFOLINOETOXI)FENIL)PIRIDIN-2-IL)-N- BENCILACETAMIDA. (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N -BENZYLACETAMIDE.)
Estimated Expiration: ⤷  Sign Up

Patent: 23001805
Patent: FORMAS SOLIDAS DE 2-(5-(4-(2-MORFOLINOETOXI)FENIL)PIRIDIN-2-IL)-N- BENCILACETAMIDA. (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N -BENZYLACETAMIDE.)
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 20112539
Patent: ТВЕРДЫЕ ФОРМЫ 2-(5-(4-(2-МОРФОЛИНОЭТОКСИ)ФЕНИЛ)ПИРИДИН-2-ИЛ)-N-БЕНЗИЛАЦЕТАМИДА
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 202001868R
Patent: SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 200081359
Patent: 2--N-벤질아세트아미드의 고체 형태
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 15820
Estimated Expiration: ⤷  Sign Up

Patent: 1920160
Patent: Solid forms of 2-(5-(4-(2-morpholinoethoxy) phenyl) pyridin-2-yl)-N-benzylacetamide
Estimated Expiration: ⤷  Sign Up

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 2015232050 キナーゼカスケードを調節するための組成物および方法 (COMPOSITION AND METHOD FOR REGULATING KINASE CASCADE) ⤷  Sign Up
Australia 2008254500 Process for the preparation of compositions for modulating a kinase cascade and methods of use thereof ⤷  Sign Up
Canada 2656564 COMPOSITIONS DE BIARYLE ET PROCEDES DE MODULATION D'UNE CASCADE DE KINASES (BIARYL COMPOSITIONS AND METHODS FOR MODULATING A KINASE CASCADE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KLISYRI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1836169 C01836169/01 Switzerland ⤷  Sign Up FORMER OWNER: ATHENEX, INC., US
1836169 122021000066 Germany ⤷  Sign Up PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716
1836169 CR 2021 00042 Denmark ⤷  Sign Up PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719
>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.