You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 19, 2026

Details for New Drug Application (NDA): 213189

✉ Email this page to a colleague

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 six patents protecting this drug. Additional details are available on the KLISYRI profile page.

The generic ingredient in KLISYRI is tirbanibulin. 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:	6

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

Generic Entry Date for 213189^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: ⤷ Get Started Free 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:	⤷ Get Started Free	Patent Expiration:	Dec 28, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	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

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020	⤷ Get Started Free	⤷ Get Started Free
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.