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Last Updated: October 26, 2021

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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 one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Alpelisib has fifty-five patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for alpelisib
International Patents:55
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 60
Clinical Trials: 30
Patent Applications: 1,995
What excipients (inactive ingredients) are in alpelisib?alpelisib excipients list
DailyMed Link:alpelisib at DailyMed
Recent Clinical Trials for alpelisib

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

SponsorPhase
Kura Oncology, Inc.Phase 1/Phase 2
Saint Luke's Health SystemPhase 2
Peter MacCallum Cancer Centre, AustraliaN/A

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

International Patents for alpelisib

Country Patent Number Estimated Expiration
Israel 210976 ⤷  Free Forever Trial
Eurasian Patent Organization 018863 ⤷  Free Forever Trial
South Korea 20110038737 ⤷  Free Forever Trial
Ukraine 104147 ⤷  Free Forever Trial
Croatia P20160014 ⤷  Free Forever Trial
Hungary S2000044 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 2010029082 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for alpelisib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331537 301071 Netherlands ⤷  Free Forever Trial PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/20/1455 20200728
2331537 PA2020534 Lithuania ⤷  Free Forever Trial PRODUCT NAME: ALPELISIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727
2331537 2020C/547 Belgium ⤷  Free Forever Trial PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728
2331537 47/2020 Austria ⤷  Free Forever Trial PRODUCT NAME: ALPELISIB ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1455 (MITTEILUNG) 20200728
2331537 LUC00186 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728
2331537 132020000000155 Italy ⤷  Free Forever Trial PRODUCT NAME: ALPELISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE.(PIQRAY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1455, 20200728
2331537 C02331537/01 Switzerland ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt
Dow

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.