AYVAKIT Drug Patent Profile
✉ Email this page to a colleague
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 eight patents protecting this drug.
This drug has seventy patent family members in thirty-four 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 was eligible for patent challenges on January 9, 2024.
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
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for AYVAKIT?
- What are the global sales for AYVAKIT?
- What is Average Wholesale Price for AYVAKIT?
Summary for AYVAKIT
International Patents: | 70 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 41 |
Clinical Trials: | 1 |
Patent Applications: | 298 |
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 |
---|---|
M.D. Anderson Cancer Center | Phase 2 |
National Cancer Institute (NCI) | Phase 2 |
Pharmacology for AYVAKIT
US Patents and Regulatory Information for AYVAKIT
AYVAKIT is protected by fifteen US patents and five FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AYVAKIT is ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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
Patent: COMPUESTOS ÚTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT
Estimated Expiration: ⤷ Try for Free
Australia
Patent: 14337314
Patent: Compositions useful for treating disorders related to KIT
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2016008541
Patent: composições úteis para tratar distúrbios relacionados a kit
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 26999
Patent: COMPOSITIONS UTILES POUR LE TRAITEMENT DE TROUBLES ASSOCIES A L'ENZYME KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷ Try for Free
China
Patent: 5658652
Patent: 可用于治疗与KIT相关的病症的组合物 (Compositions useful for treating disorders related to kit)
Estimated Expiration: ⤷ Try for Free
Patent: 0003217
Patent: 可用于治疗与KIT相关的病症的组合物 (Compositions useful for treating disorders related to KIT)
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0181388
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 21182
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 57969
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 57969
Patent: COMPOSITIONS UTILES POUR LE TRAITEMENT DE TROUBLES ASSOCIÉS À L'ENZYME KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷ Try for Free
Patent: 09674
Patent: COMPOSITIONS UTILES POUR TRAITER DES TROUBLES ASSOCIÉS À UN KIT (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 21461
Patent: 可用於治療與 相關的病症的組合物 (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT KIT)
Estimated Expiration: ⤷ Try for Free
Hungary
Patent: 39687
Estimated Expiration: ⤷ Try for Free
Patent: 59041
Estimated Expiration: ⤷ Try for Free
Patent: 100006
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 4677
Patent: תכשירים יעילים לטיפול בהפרעות הקשורות ל- kit (Compositions useful for treating disorders related to kit)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 46040
Estimated Expiration: ⤷ Try for Free
Patent: 82756
Estimated Expiration: ⤷ Try for Free
Patent: 16538257
Patent: KITに関連する疾患を治療するために有用な組成物
Estimated Expiration: ⤷ Try for Free
Patent: 19048878
Patent: 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)
Estimated Expiration: ⤷ Try for Free
Lithuania
Patent: 057969
Estimated Expiration: ⤷ Try for Free
Patent: 2021003
Estimated Expiration: ⤷ Try for Free
Patent: 57969
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 5614
Patent: COMPOSICIONES UTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT. (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT.)
Estimated Expiration: ⤷ Try for Free
Patent: 16004927
Patent: COMPOSICIONES UTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT. (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT.)
Estimated Expiration: ⤷ Try for Free
Netherlands
Patent: 1094
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 8075
Patent: Compositions useful for treating disorders related to kit
Estimated Expiration: ⤷ Try for Free
Norway
Patent: 21012
Estimated Expiration: ⤷ Try for Free
Philippines
Patent: 016500611
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 57969
Estimated Expiration: ⤷ Try for Free
Patent: 09674
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 57969
Estimated Expiration: ⤷ Try for Free
Patent: 09674
Estimated Expiration: ⤷ Try for Free
Russian Federation
Patent: 06235
Patent: КОМПОЗИЦИИ, ПРИГОДНЫЕ ДЛЯ ЛЕЧЕНИЯ РАССТРОЙСТВ, СВЯЗАННЫХ С KIT (COMPOSITIONS SUITABLE FOR TREATING DISORDERS ASSOCIATED WITH KIT)
Estimated Expiration: ⤷ Try for Free
Patent: 16118768
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 542
Patent: KOMPOZICIJE KORISNE ZA LEČENJE POREMEĆAJA POVEZANIH SA KIT-OM (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷ Try for Free
Singapore
Patent: 201602937U
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 57969
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1601970
Patent: COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 2378689
Estimated Expiration: ⤷ Try for Free
Patent: 160062173
Patent: KIT에 관련된 장애를 치료하는데 유용한 조성물 (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT)
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 83127
Estimated Expiration: ⤷ Try for Free
Patent: 23888
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 83814
Estimated Expiration: ⤷ Try for Free
Patent: 1546062
Patent: Compositions useful for treating disorders related to KIT
Estimated Expiration: ⤷ Try for Free
Uruguay
Patent: 787
Patent: COMPOSICIONES ÚTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Taiwan | 202104232 | Crystalline forms of (s)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-F][1,2,4]triazin- 4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making | ⤷ Try for Free |
Canada | 3136707 | ⤷ Try for Free | |
Mexico | 365614 | COMPOSICIONES UTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT. (COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT.) | ⤷ Try for Free |
Norway | 2021012 | ⤷ Try for Free | |
Poland | 3409674 | ⤷ Try for Free | |
Argentina | 098054 | COMPUESTOS ÚTILES PARA TRATAR TRASTORNOS RELACIONADOS CON KIT | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AYVAKIT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3057969 | C202130012 | Spain | ⤷ Try for Free | PRODUCT NAME: AVAPRITINIB Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1473; DATE OF AUTHORISATION: 20200924; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1473; DATE OF FIRST AUTHORISATION IN EEA: 20200924 |
3057969 | 21C1013 | France | ⤷ Try for Free | 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 | LUC00199 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: AVAPRITINIB ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1473 20200925 |
3057969 | PA2021003 | Lithuania | ⤷ Try for Free | PRODUCT NAME: AVAPRITINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924 |
3057969 | SPC/GB21/020 | United Kingdom | ⤷ Try for Free | PRODUCT NAME: AVAPRITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK PLGB52115/0001-0003 20200925; UK EU/1/20/1473(NI) 20200925 |
3057969 | 2021/009 | Ireland | ⤷ Try for Free | PRODUCT NAME: AVAPRITINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/20/1473 20200925 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for AYVAKIT
More… ↓