Tirbanibulin - Generic Drug Details

What are the generic sources for tirbanibulin and what is the scope of freedom to operate?

Tirbanibulin is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for tirbanibulin

International Patents:	106
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	5
Patent Applications:	189
What excipients (inactive ingredients) are in tirbanibulin?	tirbanibulin excipients list
DailyMed Link:	tirbanibulin at DailyMed

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

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.

Recent Clinical Trials for tirbanibulin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Medical University of Graz	Phase 4
Austin Institute for Clinical Research	Phase 2
Almirall, S.A.	Phase 4

See all tirbanibulin clinical trials

Pharmacology for tirbanibulin

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Anatomical Therapeutic Chemical (ATC) Classes for tirbanibulin

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

US Patents and Regulatory Information for tirbanibulin

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			Y	Y

EU/EMA Drug Approvals for tirbanibulin

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 tirbanibulin

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2018165647
Brazil	112019018687	métodos de tratamento e/ou prevenção da ceratose actínica
Canada	3074831	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)
Japan	2015028068	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 PREPARATION OF COMPOSITION FOR MODULATING KINASE CASCADE, AND METHOD FOR USING THE SAME)
Hong Kong	1188985	治療細胞增殖紊亂的化合物和方法 (COMPOSITIONS AND METHODS OF TREATING CELL PROLIFERATION DISORDERS)
Spain	2382068

Supplementary Protection Certificates for tirbanibulin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1836169	LUC00235	Luxembourg		PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:
1836169	49/2021	Austria		PRODUCT NAME: TIRBANIBULIN ODER EIN SALZ, SOLVAT ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/21/1558 (MITTEILUNG) 20210719
1836169	2021C/001	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
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	C202130061	Spain		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	CR 2021 00042	Denmark		PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719