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. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the AYVAKIT profile page.
The generic ingredient in AYVAKIT is avapritinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the avapritinib profile page.
The generic ingredient in AYVAKIT is avapritinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the avapritinib profile page.
Summary for 212608
| Tradename: | AYVAKIT |
| Applicant: | Blueprint Medicines |
| Ingredient: | avapritinib |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212608
Generic Entry Date for 212608*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM) 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.
Pharmacology for NDA: 212608
Suppliers and Packaging for NDA: 212608
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AYVAKIT | avapritinib | TABLET;ORAL | 212608 | NDA | Blueprint Medicines Corporation | 72064-110 | 72064-110-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-110-30) |
| AYVAKIT | avapritinib | TABLET;ORAL | 212608 | NDA | Blueprint Medicines Corporation | 72064-120 | 72064-120-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72064-120-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jan 9, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | 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) | ||||||||
| Regulatory Exclusivity Expiration: | Jan 9, 2027 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Regulatory Exclusivity Expiration: | May 22, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH INDOLENT SYSTEMIC MASTOCYTOSIS (ISM) | ||||||||
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