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Last Updated: April 22, 2024

Alpelisib - Generic Drug Details


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What are the generic sources for alpelisib and what is the scope of patent protection?

Alpelisib is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Alpelisib has fifty-eight patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for alpelisib
International Patents:58
US Patents:2
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 73
Clinical Trials: 63
Patent Applications: 2,670
What excipients (inactive ingredients) are in alpelisib?alpelisib excipients list
DailyMed Link:alpelisib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for alpelisib
Generic Entry Dates for alpelisib*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for alpelisib*:
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.

Recent Clinical Trials for alpelisib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of MiamiPhase 2
Columbia UniversityPhase 1
Breast Cancer Research FoundationPhase 2

See all alpelisib clinical trials

US Patents and Regulatory Information for alpelisib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis PIQRAY alpelisib TABLET;ORAL 212526-003 May 24, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis VIJOICE alpelisib TABLET;ORAL 215039-002 Apr 5, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis PIQRAY alpelisib TABLET;ORAL 212526-001 May 24, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for alpelisib

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Novartis Europharm Limited  Piqray alpelisib EMEA/H/C/004804
Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy (see section 5.1).
Authorised no no no 2020-07-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for alpelisib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331537 47/2020 Austria ⤷  Try a Trial PRODUCT NAME: ALPELISIB ODER SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/20/1455 (MITTEILUNG) 20200728; FIRST REGISTRATION: CH 67359 20200324
2331537 PA2020534,C2331537 Lithuania ⤷  Try a Trial PRODUCT NAME: ALPELISIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727
2331537 C02331537/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ALPELISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67359 24.03.2020
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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