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Last Updated: January 30, 2023

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

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

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

See all tirbanibulin clinical trials

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 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

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
Japan 5124285 See Plans and Pricing
European Patent Office 2114934 COMPOSITION ET M√ČTHODE 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

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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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Express Scripts
Boehringer Ingelheim
Harvard Business School
Johnson and Johnson

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.