Avapritinib - Generic Drug Details

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

Sponsor	Phase
Theseus Pharmaceuticals	Phase 1/Phase 2
Blueprint Medicines Corporation	Phase 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
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-001	Jan 9, 2020		RX	Yes	No
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-003	Jan 9, 2020		RX	Yes	Yes			Y	Y
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-004	Jun 16, 2021		RX	Yes	No
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-004	Jun 16, 2021		RX	Yes	No
Blueprint Medicines	AYVAKIT	avapritinib	TABLET;ORAL	212608-005	Jun 16, 2021		RX	Yes	No

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

International Patents for avapritinib

Country	Patent Number	Title	Estimated Expiration
Lithuania	3057969
South Korea	20160062173	KIT에 관련된 장애를 치료하는데 유용한 조성물 (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Netherlands	301094
South Korea	102378689
Norway	2021012
World Intellectual Property Organization (WIPO)	2015057873

Supplementary Protection Certificates for avapritinib

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