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Last Updated: May 29, 2024

Alpelisib - Generic Drug Details


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What are the generic drug 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 VIJOICE alpelisib TABLET;ORAL 215039-002 Apr 5, 2022 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis PIQRAY alpelisib TABLET;ORAL 212526-002 May 24, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis PIQRAY alpelisib TABLET;ORAL 212526-001 May 24, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis VIJOICE alpelisib TABLET;ORAL 215039-001 Apr 5, 2022 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis PIQRAY alpelisib TABLET;ORAL 212526-002 May 24, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

International Patents for alpelisib

Country Patent Number Title Estimated Expiration
Canada 2734819 COMPOSES ORGANIQUES (ORGANIC COMPOUNDS) ⤷  Sign Up
Nicaragua 201100049 COMPUESTOS ORGÁNICOS. ⤷  Sign Up
Tunisia 2011000053 ORGANIC COMPOUNDS ⤷  Sign Up
Ukraine 104147 ПРОИЗВОДНАЯ ПИРРОЛИДИНДИКАРБОНОВОЙ КИСЛОТЫ И ЕЕ ПРИМЕНЕНИЕ В ЛЕЧЕНИИ ПРОЛИФЕРАТИВНЫХ ЗАБОЛЕВАНИЙ;ПОХІДНА ПІРОЛІДИНДИКАРБОНОВОЇ КИСЛОТИ ТА ЇЇ ЗАСТОСУВАННЯ У ЛІКУВАННІ ПРОЛІФЕРАТИВНИХ ЗАХВОРЮВАНЬ (PYRROLIDINE DICARBOXYLIC ACID DERIVATIVE AND USE THEREOF IN THE TREATMENT OF PROLIFERATIVE DISEASES) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2010029082 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for alpelisib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331537 132020000000155 Italy ⤷  Sign Up PRODUCT NAME: ALPELISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE.(PIQRAY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1455, 20200728
2331537 CA 2020 00054 Denmark ⤷  Sign Up PRODUCT NAME: ALPELISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/20/1455 20200728
2331537 C20200034 00362 Estonia ⤷  Sign Up PRODUCT NAME: ALPELISIIB;REG NO/DATE: EU/1/20/1455 28.07.2020
2331537 122020000073 Germany ⤷  Sign Up PRODUCT NAME: ALPELISIB ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/20/1455 20200727; FIRST REGISTRATION: SCHWEIZ 67359 20200324
2331537 C02331537/01 Switzerland ⤷  Sign Up 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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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.