Details for New Drug Application (NDA): 212526
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NDA 212526 describes PIQRAY, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the PIQRAY profile page.
The generic ingredient in PIQRAY is alpelisib. One supplier is listed for this compound. Additional details are available on the alpelisib profile page.
The generic ingredient in PIQRAY is alpelisib. One supplier is listed for this compound. Additional details are available on the alpelisib profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212526
Generic Entry Date for 212526*:
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.
Suppliers and Packaging for NDA: 212526
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIQRAY | alpelisib | TABLET;ORAL | 212526 | NDA | Novartis Pharmaceuticals Corporation | 0078-0701 | 0078-0701-84 | 1 BLISTER PACK in 1 CARTON (0078-0701-84) / 28 TABLET in 1 BLISTER PACK (0078-0701-51) |
| PIQRAY | alpelisib | TABLET;ORAL | 212526 | NDA | Novartis Pharmaceuticals Corporation | 0078-0708 | 0078-0708-02 | 2 BLISTER PACK in 1 CARTON (0078-0708-02) / 28 TABLET in 1 BLISTER PACK (0078-0708-51) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | May 24, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 18, 2027 | ||||||||
| Regulatory Exclusivity Use: | EXPANSION OF THE INDICATION TO INCLUDE PRE AND PERIMENOPAUSAL WOMEN | ||||||||
| Regulatory Exclusivity Expiration: | May 24, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 8,227,462 | Patent Expiration: | Apr 29, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | IN COMBINATION WITH FULVESTRANT FOR TREATMENT OF ADULTS WITH HR-POSITIVE, HER-2-NEGATIVE, PIK3CA-MUTATED, ADVANCED OR METASTATIC BREAST CANCER | ||||||||
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