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 eight 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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Questions you can ask:
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Summary for KLISYRI
International Patents: | 108 |
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
Generic Entry Date for KLISYRI*:
Constraining patent/regulatory exclusivity:
NDA:
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 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 | ||
>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
Patent: Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-N-benzylacetamide
Estimated Expiration: ⤷ Sign Up
Patent: 23201010
Patent: SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2020004419
Patent: formas sólidas de 2-(5-(4-(2-morfolinoetóxi)fenil)piridin-2-il)-n-benzilacetamida
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 74831
Patent: FORMES SOLIDES DE 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1278808
Patent: 2-(5-(4-(2-吗啉代乙氧基)苯基)吡啶-2-基)-N-苄基乙酰胺的固体形式 (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 79016
Patent: FORMES SOLIDES DE 2-(5-(4-(2-MORPHOLINOÉTHOXY)PHÉNYL)PYRIDIN-2-YL)-N-BENZYLACÉTAMIDE (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 2992
Patent: תצורות מוצקות של 2-(5-(4-(2-מורפולינואתוקסי)פניל)פירידין-2-איל)-n-בנזילאצטאמיד (Solid forms of 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-n-benzylacetamide)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 20533412
Patent: 2−(5−(4−(2−モルホリノエトキシ)フェニル)ピリジン−2−イル)−N−ベンジルアセトアミドの固体形態
Estimated Expiration: ⤷ Sign Up
Patent: 23157909
Patent: 2-(5-(4-(2-モルホリノエトキシ)フェニル)ピリジン-2-イル)-N-ベンジルアセトアミドの固体形態 (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 20002622
Patent: 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.)
Estimated Expiration: ⤷ Sign Up
Patent: 23001805
Patent: 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.)
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 20112539
Patent: ТВЕРДЫЕ ФОРМЫ 2-(5-(4-(2-МОРФОЛИНОЭТОКСИ)ФЕНИЛ)ПИРИДИН-2-ИЛ)-N-БЕНЗИЛАЦЕТАМИДА
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202001868R
Patent: SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 200081359
Patent: 2--N-벤질아세트아미드의 고체 형태
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 15820
Estimated Expiration: ⤷ Sign Up
Patent: 1920160
Patent: Solid forms of 2-(5-(4-(2-morpholinoethoxy) phenyl) pyridin-2-yl)-N-benzylacetamide
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 |
---|---|---|---|
Japan | 2015232050 | キナーゼカスケードを調節するための組成物および方法 (COMPOSITION AND METHOD FOR REGULATING KINASE CASCADE) | ⤷ Sign Up |
Australia | 2008254500 | Process for the preparation of compositions for modulating a kinase cascade and methods of use thereof | ⤷ Sign Up |
Canada | 2656564 | COMPOSITIONS DE BIARYLE ET PROCEDES DE MODULATION D'UNE CASCADE DE KINASES (BIARYL COMPOSITIONS AND METHODS FOR MODULATING A KINASE CASCADE) | ⤷ 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 | C01836169/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: ATHENEX, INC., US |
1836169 | 122021000066 | Germany | ⤷ Sign Up | PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716 |
1836169 | CR 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 |