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Last Updated: February 7, 2023

Avapritinib - Generic Drug Details


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What are the generic sources for avapritinib and what is the scope of patent protection?

Avapritinib is the generic ingredient in one branded drug marketed by Blueprint Medicines and is included in one NDA. There are three 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.

Summary for avapritinib
International Patents:47
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 36
Clinical Trials: 12
Patent Applications: 121
What excipients (inactive ingredients) are in avapritinib?avapritinib excipients list
DailyMed Link:avapritinib at DailyMed
Recent Clinical Trials for avapritinib

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

SponsorPhase
Theseus PharmaceuticalsPhase 1/Phase 2
Blueprint Medicines CorporationPhase 4
National Cancer Institute (NCI)Phase 2

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-001 Jan 9, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-003 Jan 9, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-004 Jun 16, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-004 Jun 16, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-005 Jun 16, 2021 RX Yes No See Plans and Pricing See Plans and Pricing 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 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
Lithuania 3057969 See Plans and Pricing
South Korea 20160062173 KIT에 관련된 장애를 치료하는데 유용한 조성물 (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT) See Plans and Pricing
Netherlands 301094 See Plans and Pricing
South Korea 102378689 See Plans and Pricing
Norway 2021012 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2015057873 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for avapritinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3057969 C20210005 00320 Estonia See Plans and Pricing PRODUCT NAME: AVAPRITINIIB;REG NO/DATE: EU/1/20/1473 25.09.2020
3057969 CA 2021 00008 Denmark See Plans and Pricing PRODUCT NAME: AVAPRITINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/20/1473 20200925
3057969 PA2021003,C3057969 Lithuania See Plans and Pricing PRODUCT NAME: AVAPRITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924
3057969 2190008-9 Sweden See Plans and Pricing PRODUCT NAME: AVAPRITINIB OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/20/1473 20200925
3057969 LUC00199 Luxembourg See Plans and Pricing PRODUCT NAME: AVAPRITINIB ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1473 20200925
3057969 21C1013 France See Plans and Pricing 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
>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.