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KLISYRI Drug Patent Profile

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

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

See drug prices for KLISYRI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KLISYRI

NDA:

213189

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 Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Anatomical Therapeutic Chemical (ATC) Classes for KLISYRI

D06BX	Other chemotherapeutics
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for KLISYRI

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

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

FDA Regulatory Exclusivity protecting KLISYRI

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			Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes

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

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

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

Russian Federation

Singapore

South Korea

Taiwan

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	2023015269	光線角化症を治療および／または予防する方法
Hong Kong	1108695	COMPOSITIONS AND METHODS OF TREATING CELL PROLIFERATION DISORDERS
South Korea	20130079661	COMPOSITIONS AND METHODS OF TREATING CELL PROLIFERATION DISORDERS
Singapore	176161	COMPOSITIONS FOR MODULATING A KINASE CASCADE AND METHODS OF USE THEREOF
South Korea	101328273
European Patent Office	2041071	COMPOSITIONS DE BIARYLE ET PROCÉDÉS DE MODULATION D'UNE CASCADE DE KINASES (BIARYL COMPOSITIONS AND METHODS FOR MODULATING A KINASE CASCADE)

Supplementary Protection Certificates for KLISYRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1836169	SPC/GB22/002	United Kingdom		PRODUCT NAME: TIRBANIBULIN; REGISTERED: UK EU/1/21/1558(FOR NI) 20210719; UK FURTHER MA ON IPSUM 20210719
1836169	2021C/001	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1836169	LUC00235	Luxembourg		PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:
1836169	CA 2021 00042	Denmark		PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719
1836169	21C1064	France		PRODUCT NAME: TIRBANIBULINE; REGISTRATION NO/DATE: EU/1/21/1558 20210719
1836169	122021000066	Germany		PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716