Tirbanibulin - Generic Drug Details

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What are the generic drug 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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tirbanibulin has ninety-nine patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for tirbanibulin

International Patents:	99
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	202
What excipients (inactive ingredients) are in tirbanibulin?	tirbanibulin excipients list
DailyMed Link:	tirbanibulin at DailyMed

Recent Clinical Trials for tirbanibulin

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Sponsor	Phase
Almirall, S.A.	Phase 4
Almirall, S.A.	Phase 3

See all tirbanibulin clinical trials

US Patents and Regulatory Information for tirbanibulin

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Glossary

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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	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 tirbanibulin

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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 tirbanibulin

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Country	Patent Number	Title	Estimated Expiration
Japan	5124285		See Plans and Pricing
European Patent Office	2114934	COMPOSITION ET MÉTHODE DE MODULATION D'UNE CASCADE DE KINASES. (COMPOSITION AND METHODS FOR MODULATING A KINASE CASCADE)	See Plans and Pricing
Australia	2007265373	Biaryl compositions and methods for modulating a kinase cascade	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tirbanibulin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1836169	CA 2021 00042	Denmark	See Plans and Pricing	PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719
1836169	LUC00235	Luxembourg	See Plans and Pricing	PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:
1836169	C01836169/01	Switzerland	See Plans and Pricing	PRODUCT NAME: TIRBANIBULIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68322 03.02.2022
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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