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-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 |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
---|---|
National Cancer Institute (NCI) | Phase 2 |
M.D. Anderson Cancer Center | Phase 2 |
Pharmacology for AYVAKIT
Anatomical Therapeutic Chemical (ATC) Classes for AYVAKIT
US Patents and Regulatory Information for AYVAKIT
AYVAKIT is protected by nine US patents and seven FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AYVAKIT is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Compositions useful for treating disorders related to KIT
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Compositions useful for treating disorders related to kit
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Compositions useful for treating disorders related to kit
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH MAST CELL LEUKEMIA (MCL)
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608-001 | Jan 9, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608-003 | Jan 9, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608-002 | Jan 9, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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: ⤷ Try a Trial
Australia
Patent: 14337314
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2016008541
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 26999
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5658652
Estimated Expiration: ⤷ Try a Trial
Patent: 0003217
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0181388
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 21182
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 57969
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 57969
Estimated Expiration: ⤷ Try a Trial
Patent: 09674
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 21461
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 39687
Estimated Expiration: ⤷ Try a Trial
Patent: 59041
Estimated Expiration: ⤷ Try a Trial
Patent: 100006
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 4677
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 46040
Estimated Expiration: ⤷ Try a Trial
Patent: 82756
Estimated Expiration: ⤷ Try a Trial
Patent: 16538257
Estimated Expiration: ⤷ Try a Trial
Patent: 19048878
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 057969
Estimated Expiration: ⤷ Try a Trial
Patent: 2021003
Estimated Expiration: ⤷ Try a Trial
Patent: 57969
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 5614
Estimated Expiration: ⤷ Try a Trial
Patent: 16004927
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 1094
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8075
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 21012
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 016500611
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 57969
Estimated Expiration: ⤷ Try a Trial
Patent: 09674
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 57969
Estimated Expiration: ⤷ Try a Trial
Patent: 09674
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 06235
Estimated Expiration: ⤷ Try a Trial
Patent: 16118768
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 542
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201602937U
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 57969
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1601970
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2378689
Estimated Expiration: ⤷ Try a Trial
Patent: 160062173
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 83127
Estimated Expiration: ⤷ Try a Trial
Patent: 23888
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 83814
Estimated Expiration: ⤷ Try a Trial
Patent: 1546062
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 787
Estimated Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
South Korea | 20160062173 | KIT에 관련된 장애를 치료하는데 유용한 조성물 (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT) | ⤷ Try a Trial |
Hungary | E059041 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AYVAKIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3057969 | 21C1013 | France | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: AVAPRITINIIB;REG NO/DATE: EU/1/20/1473 25.09.2020 |
3057969 | 132021000000035 | Italy | ⤷ Try a Trial | PRODUCT NAME: AVAPRITINIB E SUOI SALI FARMACEUTICAMENTE ACCETTABILI(AYVAKYT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1473, 20200925 |
3057969 | 301094 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: AVAPRITINIB EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1473 20200925 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |