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Last Updated: April 21, 2024

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 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
Generic Entry Date for tirbanibulin*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Medical University of GrazPhase 4
Austin Institute for Clinical ResearchPhase 2
Almirall, S.A.Phase 4

See all tirbanibulin clinical trials

Pharmacology for tirbanibulin
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Almirall KLISYRI tirbanibulin OINTMENT;TOPICAL 213189-001 Dec 14, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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

Country Patent Number Title Estimated Expiration
Malaysia 158648 COMPOSITIONS FOR MODULATING A KINASE CASCADE AND METHODS OF USE THEREOF ⤷  Try a Trial
Japan 5679811 ⤷  Try a Trial
Spain 2682108 ⤷  Try a Trial
Mexico 2020002622 FORMAS SOLIDAS DE 2-(5-(4-(2-MORFOLINOETOXI)FENIL)PIRIDIN-2-IL)-N- BENCILACETAMIDA. (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N -BENZYLACETAMIDE.) ⤷  Try a Trial
Taiwan 201842913 Methods of treating and/or preventing actinic keratosis ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tirbanibulin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1836169 122021000066 Germany ⤷  Try a Trial PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716
1836169 49/2021 Austria ⤷  Try a Trial PRODUCT NAME: TIRBANIBULIN ODER EIN SALZ, SOLVAT ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/21/1558 (MITTEILUNG) 20210719
1836169 SPC/GB22/002 United Kingdom ⤷  Try a Trial PRODUCT NAME: TIRBANIBULIN; REGISTERED: UK EU/1/21/1558(FOR NI) 20210719; UK FURTHER MA ON IPSUM 20210719
1836169 C01836169/01 Switzerland ⤷  Try a Trial FORMER OWNER: ATHENEX, INC., US
1836169 301145 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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. 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.