KLISYRI Drug Patent Profile
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When do Klisyri patents expire, and when can generic versions of Klisyri launch?
Klisyri is a drug marketed by Almirall and is included in one NDA. There are eight patents protecting this drug.
This drug has one hundred and fourteen patent family members in twenty-six countries.
The generic ingredient in KLISYRI is tirbanibulin. One supplier is listed for this compound. Additional details are available on the tirbanibulin profile page.
DrugPatentWatch® Generic Entry Outlook for Klisyri
Klisyri will be eligible for patent challenges on December 14, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 7, 2038. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for KLISYRI
| International Patents: | 114 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 65 |
| Patent Applications: | 119 |
| Drug Prices: | Drug price information for KLISYRI |
| What excipients (inactive ingredients) are in KLISYRI? | KLISYRI excipients list |
| DailyMed Link: | KLISYRI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KLISYRI
*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 KLISYRI
| Drug Class | Microtubule Inhibitor |
| Physiological Effect | Microtubule Inhibition |
US Patents and Regulatory Information for KLISYRI
KLISYRI is protected by eight US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KLISYRI is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting KLISYRI
Compositions for modulating a kinase cascade and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of treating and/or preventing actinic keratosis
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP
Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP
Compositions for treating cell proliferation disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Composition and methods for modulating a kinase cascade
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP
Biaryl compositions and methods for modulating a kinase cascade
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions and methods of treating cell proliferation disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting KLISYRI
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
EXPANSION OF THE TREATMENT FIELD ON THE FACE OR SCALP UP TO 100 CM^2
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Almirall | KLISYRI | tirbanibulin | OINTMENT;TOPICAL | 213189-001 | Dec 14, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Almirall | KLISYRI | tirbanibulin | OINTMENT;TOPICAL | 213189-001 | Dec 14, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Almirall | KLISYRI | tirbanibulin | OINTMENT;TOPICAL | 213189-001 | Dec 14, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 KLISYRI
| 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 KLISYRI
When does loss-of-exclusivity occur for KLISYRI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 18330163
Estimated Expiration: ⤷ Sign Up
Patent: 23201010
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2020004419
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 74831
Estimated Expiration: ⤷ Sign Up
China
Patent: 1278808
Estimated Expiration: ⤷ Sign Up
Patent: 8439992
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 79016
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 2992
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 20533412
Estimated Expiration: ⤷ Sign Up
Patent: 23157909
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 20002622
Estimated Expiration: ⤷ Sign Up
Patent: 23001805
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 20112539
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202001868R
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2691700
Estimated Expiration: ⤷ Sign Up
Patent: 200081359
Estimated Expiration: ⤷ Sign Up
Patent: 240119192
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 15820
Estimated Expiration: ⤷ Sign Up
Patent: 1920160
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering KLISYRI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2007265373 | Biaryl compositions and methods for modulating a kinase cascade | ⤷ Sign Up |
| South Korea | 20190141661 | 광선 각화증의 치료 및/또는 예방 방법 | ⤷ Sign Up |
| European Patent Office | 1836169 | COMPOSITIONS ET PROCÉDÉS DE TRAITEMENT DE TROUBLES IMPLIQUANT UNE PROLIFÉRATION CELLULAIRE (COMPOSITIONS AND METHODS OF TREATING CELL PROLIFERATION DISORDERS) | ⤷ Sign Up |
| Japan | 2009542680 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KLISYRI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1836169 | LUC00235 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE: |
| 1836169 | 21C1064 | France | ⤷ Sign Up | PRODUCT NAME: TIRBANIBULINE; REGISTRATION NO/DATE: EU/1/21/1558 20210719 |
| 1836169 | SPC/GB22/002 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TIRBANIBULIN; REGISTERED: UK EU/1/21/1558(FOR NI) 20210719; UK FURTHER MA ON IPSUM 20210719 |
| 1836169 | CA 2021 00042 | Denmark | ⤷ Sign Up | PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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. 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.
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