Last Updated: September 27, 2026

Details for New Drug Application (NDA): 213189

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NDA 213189 describes KLISYRI, which is a drug marketed by Almirall and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the KLISYRI profile page.

The generic ingredient in KLISYRI is tirbanibulin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tirbanibulin profile page.

Summary for 213189

Tradename:	KLISYRI
Applicant:	Almirall
Ingredient:	tirbanibulin
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213189

Generic Entry Date for 213189^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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 NDA: 213189

Physiological Effect	Microtubule Inhibition

Suppliers and Packaging for NDA: 213189

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189	NDA	Almirall, LLC	16110-391	16110-391-05	5 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKET
KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189	NDA	Almirall, LLC	16110-391	16110-391-55	5 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	1%
Approval Date:	Dec 14, 2020	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 7, 2027
Regulatory Exclusivity Use:	EXPANSION OF THE TREATMENT FIELD ON THE FACE OR SCALP UP TO 100 CM^2
Patent:	⤷ Start Trial	Patent Expiration:	Dec 28, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Mar 12, 2038	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP

Expired US Patents for NDA 213189

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020	⤷ Start Trial	⤷ Start Trial
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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