AYVAKIT Drug Patent Profile

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 three 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 will be eligible for patent challenges on January 9, 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 October 15, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for AYVAKIT

International Patents:	47
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	1
Patent Applications:	38
Drug Prices:	Drug price information for AYVAKIT
What excipients (inactive ingredients) are in AYVAKIT?	AYVAKIT excipients list
DailyMed Link:	AYVAKIT at DailyMed

See drug prices for AYVAKIT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AYVAKIT

NDA:

212608

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
M.D. Anderson Cancer Center	Phase 2

See all AYVAKIT clinical trials

Pharmacology for AYVAKIT

Drug Class	Kinase Inhibitor
Mechanism of Action	Bile Salt Export Pump Inhibitors Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C9 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors P-Glycoprotein Inhibitors Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AYVAKIT

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for AYVAKIT

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

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

FDA Regulatory Exclusivity protecting AYVAKIT

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	212608-002	Jan 9, 2020		RX	Yes	No

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

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

Netherlands

New Zealand

Norway

Philippines

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Uruguay

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
Japan	2016538257	ＫＩＴに関連する疾患を治療するために有用な組成物
China	105658652	可用于治疗与KIT相关的病症的组合物 (Compositions useful for treating disorders related to kit)
South Korea	20160062173	KIT에 관련된 장애를 치료하는데 유용한 조성물 (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Hungary	E059041

Supplementary Protection Certificates for AYVAKIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
3057969	C20210005 00320	Estonia		PRODUCT NAME: AVAPRITINIIB;REG NO/DATE: EU/1/20/1473 25.09.2020
3057969	132021000000035	Italy		PRODUCT NAME: AVAPRITINIB E SUOI SALI FARMACEUTICAMENTE ACCETTABILI(AYVAKYT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1473, 20200925
3057969	301094	Netherlands		PRODUCT NAME: AVAPRITINIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1473 20200925