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Last Updated: July 20, 2024

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AYVAKIT Drug Patent Profile


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Which patents cover Ayvakit, and what generic alternatives are available?

Ayvakit is a drug marketed by Blueprint Medicines and is included in one NDA. There are five patents protecting this drug.

This drug has forty-seven patent family members in thirty-one countries.

The generic ingredient in AYVAKIT is avapritinib. One supplier is listed for this compound. Additional details are available on the avapritinib profile page.

DrugPatentWatch® Generic Entry Outlook for Ayvakit

Ayvakit was eligible for patent challenges on January 9, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 15, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for AYVAKIT
International Patents:47
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 41
Clinical Trials: 1
Patent Applications: 28
Drug Prices: Drug price information for AYVAKIT
What excipients (inactive ingredients) are in AYVAKIT?AYVAKIT excipients list
DailyMed Link:AYVAKIT at DailyMed
Drug patent expirations by year for AYVAKIT
Drug Prices for AYVAKIT

See drug prices for AYVAKIT

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AYVAKIT
Generic Entry Date for AYVAKIT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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 AYVAKIT

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
M.D. Anderson Cancer CenterPhase 2

See all AYVAKIT clinical trials

US Patents and Regulatory Information for AYVAKIT

AYVAKIT is protected by eleven US patents and seven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AYVAKIT 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 AYVAKIT


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions useful for treating disorders related to KIT
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADVANCED SYSTEMIC MASTOCYTOSIS, INCLUDING PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL)

Compositions useful for treating disorders related to KIT
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)

Compositions useful for treating disorders related to KIT
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION

Compositions useful for treating disorders related to kit
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADVANCED SYSTEMIC MASTOCYTOSIS, INCLUDING PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL)

Compositions useful for treating disorders related to kit
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)

Compositions useful for treating disorders related to kit
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION

Compositions useful for treating disorders related to kit
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADVANCED SYSTEMIC MASTOCYTOSIS, INCLUDING PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL)

Compositions useful for treating disorders related to kit
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)

Compositions useful for treating disorders related to kit
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION

FDA Regulatory Exclusivity protecting AYVAKIT

TREATMENT OF ADULT PATIENTS WITH ADVANCED SYSTEMIC MASTOCYTOSIS (ADVSM), INCLUDING PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM) AND SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN)
Exclusivity Expiration: ⤷  Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH MAST CELL LEUKEMIA (MCL)
Exclusivity Expiration: ⤷  Sign Up

FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED SYSTEMIC MASTOCYTOSIS (ADVSM). ADVSM INCLUDES PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH AN ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), AND MAST CELL LEUKEMIA (MCL)
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Exclusivity Expiration: ⤷  Sign Up

INDICATED FOR THE TREATMENT OF ADULTS WITH UNRESECTABLE OR METASTATIC GIST HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION, INCLUDING PDGFRA D842V MUTATIONS
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
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-002 Jan 9, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-001 Jan 9, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-002 Jan 9, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-002 Jan 9, 2020 RX Yes No ⤷  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 AYVAKIT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Blueprint Medicines (Netherlands) B.V. Ayvakyt avapritinib EMEA/H/C/005208
Ayvakyt is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) harbouring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation.
Authorised no no yes 2020-09-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for AYVAKIT

When does loss-of-exclusivity occur for AYVAKIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8054
Patent: COMPUESTOS ÚTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 14337314
Patent: Compositions useful for treating disorders related to KIT
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2016008541
Patent: composições úteis para tratar distúrbios relacionados a kit
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 26999
Patent: COMPOSITIONS UTILES POUR LE TRAITEMENT DE TROUBLES ASSOCIES A L'ENZYME KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷  Sign Up

China

Patent: 5658652
Patent: 可用于治疗与KIT相关的病症的组合物 (Compositions useful for treating disorders related to kit)
Estimated Expiration: ⤷  Sign Up

Patent: 0003217
Patent: 可用于治疗与KIT相关的病症的组合物 (Compositions useful for treating disorders related to KIT)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0181388
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 21182
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 57969
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 57969
Patent: COMPOSITIONS UTILES POUR LE TRAITEMENT DE TROUBLES ASSOCIÉS À L'ENZYME KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷  Sign Up

Patent: 09674
Patent: COMPOSITIONS UTILES POUR TRAITER DES TROUBLES ASSOCIÉS À UN KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 21461
Patent: 可用於治療與 相關的病症的組合物 (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT KIT)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 39687
Estimated Expiration: ⤷  Sign Up

Patent: 59041
Estimated Expiration: ⤷  Sign Up

Patent: 100006
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 4677
Patent: תכשירים יעילים לטיפול בהפרעות הקשורות ל- kit (Compositions useful for treating disorders related to kit)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 46040
Estimated Expiration: ⤷  Sign Up

Patent: 82756
Estimated Expiration: ⤷  Sign Up

Patent: 16538257
Patent: KITに関連する疾患を治療するために有用な組成物
Estimated Expiration: ⤷  Sign Up

Patent: 19048878
Patent: KITに関連する疾患を治療するために有用な組成物 (COMPOSITION USEFUL FOR TREATMENT OF DISEASED RELATED TO KIT)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 057969
Estimated Expiration: ⤷  Sign Up

Patent: 2021003
Estimated Expiration: ⤷  Sign Up

Patent: 57969
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 5614
Patent: COMPOSICIONES UTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT. (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT.)
Estimated Expiration: ⤷  Sign Up

Patent: 16004927
Patent: COMPOSICIONES UTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT. (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT.)
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 1094
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8075
Patent: Compositions useful for treating disorders related to kit
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 21012
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 016500611
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 57969
Estimated Expiration: ⤷  Sign Up

Patent: 09674
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 57969
Estimated Expiration: ⤷  Sign Up

Patent: 09674
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 06235
Patent: КОМПОЗИЦИИ, ПРИГОДНЫЕ ДЛЯ ЛЕЧЕНИЯ РАССТРОЙСТВ, СВЯЗАННЫХ С KIT (COMPOSITIONS SUITABLE FOR TREATING DISORDERS ASSOCIATED WITH KIT)
Estimated Expiration: ⤷  Sign Up

Patent: 16118768
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 542
Patent: KOMPOZICIJE KORISNE ZA LEČENJE POREMEĆAJA POVEZANIH SA KIT-OM (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201602937U
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 57969
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1601970
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2378689
Estimated Expiration: ⤷  Sign Up

Patent: 160062173
Patent: KIT에 관련된 장애를 치료하는데 유용한 조성물 (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 83127
Estimated Expiration: ⤷  Sign Up

Patent: 23888
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 83814
Estimated Expiration: ⤷  Sign Up

Patent: 1546062
Patent: Compositions useful for treating disorders related to KIT
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 787
Patent: COMPOSICIONES ÚTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT
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 AYVAKIT around the world.

Country Patent Number Title Estimated Expiration
Lithuania PA2021003 ⤷  Sign Up
Australia 2014337314 Compositions useful for treating disorders related to KIT ⤷  Sign Up
Spain 2683127 ⤷  Sign Up
Mexico 2016004927 COMPOSICIONES UTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT. (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AYVAKIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3057969 PA2021003 Lithuania ⤷  Sign Up PRODUCT NAME: AVAPRITINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924
3057969 2190008-9 Sweden ⤷  Sign Up PRODUCT NAME: AVAPRITINIB OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/20/1473 20200925
3057969 C20210005 00320 Estonia ⤷  Sign Up PRODUCT NAME: AVAPRITINIIB;REG NO/DATE: EU/1/20/1473 25.09.2020
3057969 PA2021003,C3057969 Lithuania ⤷  Sign Up PRODUCT NAME: AVAPRITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924
>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.