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