AYVAKIT Drug Patent Profile
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Which patents cover Ayvakit, and when can generic versions of Ayvakit launch?
Ayvakit is a drug marketed by Blueprint Medicines and is included in one NDA. There are four 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 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
Summary for AYVAKIT
| International Patents: | 47 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 41 |
| 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
*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 ten US patents and seven FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of AYVAKIT is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Compositions useful for treating disorders related to KIT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Compositions useful for treating disorders related to KIT
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Compositions useful for treating disorders related to kit
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Compositions useful for treating disorders related to kit
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF ADULT PATIENTS WITH MAST CELL LEUKEMIA (MCL)
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM)
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608-002 | Jan 9, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608-003 | Jan 9, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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: ⤷ Sign Up
Australia
Patent: 14337314
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016008541
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 26999
Estimated Expiration: ⤷ Sign Up
China
Patent: 5658652
Estimated Expiration: ⤷ Sign Up
Patent: 0003217
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0181388
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 21182
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 57969
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 57969
Estimated Expiration: ⤷ Sign Up
Patent: 09674
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 21461
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 39687
Estimated Expiration: ⤷ Sign Up
Patent: 59041
Estimated Expiration: ⤷ Sign Up
Patent: 100006
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4677
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 46040
Estimated Expiration: ⤷ Sign Up
Patent: 82756
Estimated Expiration: ⤷ Sign Up
Patent: 16538257
Estimated Expiration: ⤷ Sign Up
Patent: 19048878
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 057969
Estimated Expiration: ⤷ Sign Up
Patent: 2021003
Estimated Expiration: ⤷ Sign Up
Patent: 57969
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 5614
Estimated Expiration: ⤷ Sign Up
Patent: 16004927
Estimated Expiration: ⤷ Sign Up
Netherlands
Patent: 1094
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8075
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 21012
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 016500611
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 57969
Estimated Expiration: ⤷ Sign Up
Patent: 09674
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 57969
Estimated Expiration: ⤷ Sign Up
Patent: 09674
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 06235
Estimated Expiration: ⤷ Sign Up
Patent: 16118768
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 542
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201602937U
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 57969
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1601970
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2378689
Estimated Expiration: ⤷ Sign Up
Patent: 160062173
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 83127
Estimated Expiration: ⤷ Sign Up
Patent: 23888
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 83814
Estimated Expiration: ⤷ Sign Up
Patent: 1546062
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 787
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Norway | 2021012 | ⤷ Sign Up | |
| Singapore | 11201602937U | COMPOSITIONS USEFUL FOR TREATING DISORDERS RELATED TO KIT | ⤷ Sign Up |
| Denmark | 3057969 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AYVAKIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3057969 | PA2021003,C3057969 | Lithuania | ⤷ Sign Up | PRODUCT NAME: AVAPRITINIBAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS; REGISTRATION NO/DATE: EU/1/20/1473 20200924 |
| 3057969 | CA 2021 00008 | Denmark | ⤷ Sign Up | PRODUCT NAME: AVAPRITINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/20/1473 20200925 |
| 3057969 | LUC00199 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AVAPRITINIB ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1473 20200925 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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