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Last Updated: July 7, 2020

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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.
Summary for 212526
Tradename:PIQRAY
Applicant:Novartis
Ingredient:alpelisib
Patents:2
Generic Entry Opportunity 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:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 24, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:May 24, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Sep 28, 2030Product Flag?YSubstance Flag?YDelist Request?
Patented Use:IN COMBINATION WITH FULVESTRANT FOR TREATMENT OF POSTMENOPAUSAL WOMEN, AND MEN, WITH HR-POSITIVE, HER-2-NEGATIVE, PIK3CA-MUTATED, ADVANCED OR METASTATIC BREAST CANCER
Patent:  Start TrialPatent Expiration:Sep 10, 2029Product Flag?YSubstance Flag?YDelist Request?

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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.