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Last Updated: March 28, 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 VIJOICE alpelisib TABLET;ORAL 215039-003 Apr 5, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis PIQRAY alpelisib TABLET;ORAL 212526-002 May 24, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis VIJOICE alpelisib TABLET;ORAL 215039-003 Apr 5, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis PIQRAY alpelisib TABLET;ORAL 212526-001 May 24, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

International Patents for alpelisib

Country Patent Number Title Estimated Expiration
Honduras 2011000699 EL COMPUESTO (S)-1-({4-METIL-5-[2-(2,2,2-TRIFLUORO-1,1-DIMETIL-ETIL)-PIRIDIN-4-IL]-TIAZOL-2-IL}-AMIDA) DE 2-AMIDA DEL ACIDO PIRROLIDIN-1,2-DICARBOXILICO EN FORMA LIBRE O DE SAL Y COMPOSICIONES Y COMPOSICION FARMACEUTICA QUE LO CONTIENE. ⤷  Try a Trial
Peru 20110796 (S)-1-({4-METIL-5-[2-(2,2,2-TRIFLUORO-1,1-DIMETIL-ETIL)-PIRIDIN-4-IL]-TIAZOL-2-IL}-AMIDA) DE 2-AMIDA DEL ACIDO PIRROLIDIN-1,2-DICARBOXILICO COMO INHIBIDOR DE LA CINASA DE FOSFATIDILINOSITOL (PI3K) ⤷  Try a Trial
Georgia, Republic of P20135991 2-CARBOXAMIDE-PYRROLIDINE-AMIDE UREA DERIVATIVES SUBSTITUTED WITH PYRIMIDINE-4-YL, AND USAGE THEREAT TREATMENT OF DISEASES CAUSED BY PHOSPHATIDYL INOSITOL 3-KINASE ⤷  Try a Trial
Denmark 2331537 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for alpelisib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331537 2020C/547 Belgium ⤷  Try a Trial PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728
2331537 LUC00186 Luxembourg ⤷  Try a Trial PRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728
2331537 301071 Netherlands ⤷  Try a Trial PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/20/1455 20200728
2331537 PA2020534 Lithuania ⤷  Try a Trial PRODUCT NAME: ALPELISIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727
>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.