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
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 |
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
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for AYVAKIT
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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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.
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