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AYVAKIT Drug 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 thirty-six patent family members in twenty-eight 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: | 36 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 25 |
| Clinical Trials: | 1 |
| Patent Applications: | 10 |
| 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 |
US Patents and Regulatory Information for AYVAKIT
| 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 | 212608-001 | Jan 9, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608-002 | Jan 9, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608-001 | Jan 9, 2020 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608-003 | Jan 9, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Blueprint Medicines | AYVAKIT | avapritinib | TABLET;ORAL | 212608-002 | Jan 9, 2020 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3057969 | Start Trial |
| Hungary | E039687 | Start Trial |
| Taiwan | I683814 | Start Trial |
| Croatia | P20181388 | Start Trial |
| Canada | 2926999 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
