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Last Updated: February 28, 2024

Avapritinib - Generic Drug Details


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What are the generic drug sources for avapritinib and what is the scope of freedom to operate?

Avapritinib is the generic ingredient in one branded drug marketed by Blueprint Medicines and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for avapritinib
International Patents:47
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 41
Clinical Trials: 13
Patent Applications: 116
What excipients (inactive ingredients) are in avapritinib?avapritinib excipients list
DailyMed Link:avapritinib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for avapritinib
Generic Entry Date for avapritinib*:
Constraining patent/regulatory exclusivity:
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 avapritinib

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

SponsorPhase
The First Affiliated Hospital of Soochow UniversityPhase 2
Theseus PharmaceuticalsPhase 1/Phase 2
Blueprint Medicines CorporationPhase 4

See all avapritinib clinical trials

US Patents and Regulatory Information for avapritinib

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-004 Jun 16, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-005 Jun 16, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-003 Jan 9, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-002 Jan 9, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-003 Jan 9, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 avapritinib

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 avapritinib

Country Patent Number Title Estimated Expiration
Denmark 3057969 ⤷  Try a Trial
South Africa 201601970 COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT ⤷  Try a Trial
Canada 2926999 COMPOSITIONS UTILES POUR LE TRAITEMENT DE TROUBLES ASSOCIES A L'ENZYME KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT) ⤷  Try a Trial
European Patent Office 3409674 COMPOSITIONS UTILES POUR TRAITER DES TROUBLES ASSOCIÉS À UN KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT) ⤷  Try a Trial
Slovenia 3057969 ⤷  Try a Trial
Japan 6446040 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for avapritinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3057969 PA2021003,C3057969 Lithuania ⤷  Try a Trial PRODUCT NAME: AVAPRITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924
3057969 2021C/509 Belgium ⤷  Try a Trial PRODUCT NAME: AVAPRITINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/20/1473 20200925
3057969 PA2021003 Lithuania ⤷  Try a Trial PRODUCT NAME: AVAPRITINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924
3057969 C202130012 Spain ⤷  Try a Trial PRODUCT NAME: AVAPRITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1473; DATE OF AUTHORISATION: 20200924; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1473; DATE OF FIRST AUTHORISATION IN EEA: 20200924
3057969 21C1013 France ⤷  Try a Trial PRODUCT NAME: AVAPRITINIB ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/20/1473 20200925; FIRST REGISTRATION: - EU/1/20/1473 20200925
3057969 C20210005 00320 Estonia ⤷  Try a Trial PRODUCT NAME: AVAPRITINIIB;REG NO/DATE: EU/1/20/1473 25.09.2020
>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.