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Last Updated: May 24, 2022

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 three patents protecting this drug.

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

The generic ingredient in AYVAKIT is avapritinib. 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

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Summary for AYVAKIT
International Patents:42
US Patents:3
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 33
Clinical Trials: 1
Patent Applications: 27
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 Generic Entry Opportunity 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
M.D. Anderson Cancer CenterPhase 2
National Cancer Institute (NCI)Phase 2

See all AYVAKIT clinical trials

US Patents and Regulatory Information for AYVAKIT

AYVAKIT is protected by six US patents and five FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AYVAKIT is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Compositions useful for treating disorders related to KIT
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH MAST CELL LEUKEMIA (MCL)
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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: 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
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 212608-002 Jan 9, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Blueprint Medicines AYVAKIT avapritinib TABLET;ORAL 212608-002 Jan 9, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y Y 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

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
Estimated Expiration: See Plans and Pricing

Australia

Patent: 14337314
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2016008541
Estimated Expiration: See Plans and Pricing

Canada

Patent: 26999
Estimated Expiration: See Plans and Pricing

China

Patent: 5658652
Estimated Expiration: See Plans and Pricing

Patent: 0003217
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0181388
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 21182
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 57969
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 57969
Estimated Expiration: See Plans and Pricing

Patent: 09674
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 21461
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 39687
Estimated Expiration: See Plans and Pricing

Patent: 100006
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4677
Estimated Expiration: See Plans and Pricing

Japan

Patent: 46040
Estimated Expiration: See Plans and Pricing

Patent: 82756
Estimated Expiration: See Plans and Pricing

Patent: 16538257
Estimated Expiration: See Plans and Pricing

Patent: 19048878
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 2021003
Estimated Expiration: See Plans and Pricing

Patent: 57969
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 5614
Estimated Expiration: See Plans and Pricing

Patent: 16004927
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 1094
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8075
Estimated Expiration: See Plans and Pricing

Norway

Patent: 21012
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 016500611
Estimated Expiration: See Plans and Pricing

Poland

Patent: 57969
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 57969
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 06235
Estimated Expiration: See Plans and Pricing

Patent: 16118768
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 542
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201602937U
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 57969
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1601970
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 160062173
Estimated Expiration: See Plans and Pricing

Spain

Patent: 83127
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 83814
Estimated Expiration: See Plans and Pricing

Patent: 1546062
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 787
Estimated Expiration: See Plans and Pricing

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 2019048878 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) See Plans and Pricing
Taiwan 201546062 Compositions useful for treating disorders related to KIT See Plans and Pricing
South Korea 102378689 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AYVAKIT

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 2021C/509 Belgium See Plans and Pricing PRODUCT NAME: AVAPRITINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; 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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Serving leading biopharmaceutical companies globally:

Dow
Merck
Baxter
Johnson and Johnson
McKesson
Moodys

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.