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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212608


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NDA 212608 describes AYVAKIT, which is a drug marketed by Blueprint Medicines and is included in one NDA. There are three patents protecting this drug. Additional details are available on the AYVAKIT profile page.

The generic ingredient in AYVAKIT is avapritinib. Additional details are available on the avapritinib profile page.
Summary for 212608
Tradename:AYVAKIT
Applicant:Blueprint Medicines
Ingredient:avapritinib
Patents:3
Generic Entry Opportunity Date for 212608
Generic Entry Date for 212608*:
Constraining patent/regulatory exclusivity:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 9, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 9, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Oct 15, 2034Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION
Patent:  Start TrialPatent Expiration:Oct 15, 2034Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF UNRESECTABLE OR METASTATIC GASTROINTESTINAL STROMAL TUMOR (GIST) HARBORING A PLATELET-DERIVED GROWTH FACTOR RECEPTOR ALPHA (PDGFRA) EXON 18 MUTATION

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