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Last Updated: June 24, 2024

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PIQRAY Drug Patent Profile


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Which patents cover Piqray, and when can generic versions of Piqray launch?

Piqray is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-eight patent family members in forty-eight countries.

The generic ingredient in PIQRAY is alpelisib. One supplier is listed for this compound. Additional details are available on the alpelisib profile page.

DrugPatentWatch® Generic Entry Outlook for Piqray

Piqray was eligible for patent challenges on May 24, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 29, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for PIQRAY
International Patents:58
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 73
Clinical Trials: 16
Patent Applications: 830
Drug Prices: Drug price information for PIQRAY
What excipients (inactive ingredients) are in PIQRAY?PIQRAY excipients list
DailyMed Link:PIQRAY at DailyMed
Drug patent expirations by year for PIQRAY
Drug Prices for PIQRAY

See drug prices for PIQRAY

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PIQRAY
Generic Entry Date for PIQRAY*:
Constraining patent/regulatory exclusivity:
NDA:
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 PIQRAY

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

SponsorPhase
Columbia UniversityPhase 1
Stemline Therapeutics, Inc.Phase 1/Phase 2
Celcuity, Inc.Phase 3

See all PIQRAY clinical trials

US Patents and Regulatory Information for PIQRAY

PIQRAY is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PIQRAY is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PIQRAY

Pyrrolidine-1,2-dicarboxamide derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: IN COMBINATION WITH FULVESTRANT FOR TREATMENT OF ADULTS WITH HR-POSITIVE, HER-2-NEGATIVE, PIK3CA-MUTATED, ADVANCED OR METASTATIC BREAST CANCER

Pyrrolidine-1,2-dicarboxamide derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting PIQRAY

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

EXPANSION OF THE INDICATION TO INCLUDE PRE AND PERIMENOPAUSAL WOMEN
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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 PIQRAY alpelisib TABLET;ORAL 212526-003 May 24, 2019 RX Yes Yes ⤷  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 PIQRAY

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 PIQRAY

When does loss-of-exclusivity occur for PIQRAY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 3369
Patent: DERIVADOS DE 2-CARBOXAMIDA-CICLOAMINO-UREA COMO INHIBIDORES DE PI-3
Estimated Expiration: ⤷  Sign Up

Patent: 2074
Patent: DERIVADOS DE 2-CARBOXAMIDA-CICLOAMINO-UREA COMO INHIBIDORES DE PI-3
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09290904
Patent: Organic compounds
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0918750
Patent: compostos orgânicos
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 34819
Patent: COMPOSES ORGANIQUES (ORGANIC COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 11000504
Patent: Compuestos derivados de piridin-4-il-tiazol-2il-amida 2-amida-pirrolidin-1,2-dicarboxilico, inhibidores de quinasa de fosfatidil-inositol-3; composicion farmaceutica que comprende a uno de los compuestos; y uso de los compuestos en la preparacion de un medicamento para el tratamiento del cancer.
Estimated Expiration: ⤷  Sign Up

China

Patent: 2149711
Patent: Organic compounds
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 51738
Patent: COMPUESTOS ORGANICOS
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 110059
Patent: COMPUESTOS ORGANICOS
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0160014
Estimated Expiration: ⤷  Sign Up

Cuba

Patent: 000
Patent: UN DERIVADO 2-CARBOXAMIDA-CICLOAMINO-UREA-TIAZOL-PIRIDILO
Estimated Expiration: ⤷  Sign Up

Patent: 110052
Patent: COMPUESTOS ORGÁNICOS
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 17078
Estimated Expiration: ⤷  Sign Up

Patent: 20037
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 31537
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 011000070
Patent: COMPUESTOS ORGANICOS
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 11010880
Patent: COMPUESTOS ORGÁNICOS
Estimated Expiration: ⤷  Sign Up

El Salvador

Patent: 11003853
Patent: COMPUESTOS ORGANICOS
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8863
Patent: ОРГАНИЧЕСКИЕ СОЕДИНЕНИЯ (ORGANIC COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Patent: 1100447
Patent: ОРГАНИЧЕСКИЕ СОЕДИНЕНИЯ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 31537
Patent: DÉRIVÉS DE 1-((5-HÉTÉROARYLTHIAZOL-2-YL)AMINOCARBONYL)PYRROLIDINE-2-CARBOXAMIDE COMME INHIBITEURS DE PHOSPHATIDYLINOSITOL 3-KINASE (PI3K) UTILES DANS LE TRAITEMENT DE MALADIES PROLIFÉRATIVES (1-((5-HETEROARYLTHIAZOL-2-YL)AMINOCARBONYL)PYRROLIDINE-2-CARBOXAMIDE DERIVATIVES AS PHOSPHATIDYLINOSITOL 3-KINASE (PI3K) INHIBITORS USEFUL IN THE TREATMENT OF PROLIFERATIVE DISEASES)
Estimated Expiration: ⤷  Sign Up

Georgia, Republic of

Patent: 0135991
Patent: 2-CARBOXAMIDE-PYRROLIDINE-AMIDE UREA DERIVATIVES SUBSTITUTED WITH PYRIMIDINE-4-YL, AND USAGE THEREAT TREATMENT OF DISEASES CAUSED BY PHOSPHATIDYL INOSITOL 3-KINASE
Estimated Expiration: ⤷  Sign Up

Honduras

Patent: 11000699
Patent: 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.
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 56305
Patent: 作為磷脂醯肌醇- 肌酵素 抑制物而有用於治療增生性疾病之 -羧酸基- -雜芳基噻唑- -基 氨基羰基 吡咯烷衍生物 (1-((5-HETEROARYLTHIAZOL-2-YL)AMINOCARBONYL)PYRROLIDINE-2-CARBOXAMIDE DERIVATIVES AS PHOSPHATIDYLINOSITOL 3-KINASE (PI3K) INHIBITORS USEFUL IN THE TREATMENT OF PROLIFERATIVE DISEASES -3 (PI3K) 2--1-((5- -2-)))
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 25884
Estimated Expiration: ⤷  Sign Up

Patent: 000044
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0976
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 86601
Estimated Expiration: ⤷  Sign Up

Patent: 12502080
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 21
Patent: مشتقات 1 - ((5-هيتيرورلثيازول-2-يل) أمينوكاربونيل) بيروليدين-2-كربوكساميد كمثبات الفوسفاتديلينوسيتول 3-كيناس (PI3K) مفيدة في علاج الأمراض التصاعدية (1-((5-HETEROARYLTHIAZOL-2-YL)AMINOCARBONYL)PYRROLIDINE-2-CARBOXAMIDE DERIVATIVES AS PHOSPHATIDYLINOSITOL 3-KINASE (PI3K) INHIBITORS USEFUL IN THE TREATMENT OF PROLIFERATIVE DISEASES)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 331537
Estimated Expiration: ⤷  Sign Up

Patent: 2020534
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 1556
Patent: ORGANIC COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 11002597
Patent: COMPUESTOS ORGANICOS. (ORGANIC COMPOUNDS.)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 284
Patent: ORGANSKA JEDINJENJA (ORGANIC COMPOUNDS)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 604
Patent: مركبات عضوية
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 1071
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0754
Patent: Pyridin-4-yl substituted 2-carboxamide pyrrolidine-amide urea derivatives and their use in the treatment of phosphatidylinositol 3-kinase mediated diseases
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 1100049
Patent: COMPUESTOS ORGÁNICOS.
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 20037
Estimated Expiration: ⤷  Sign Up

Panama

Patent: 41901
Patent: COMPUESTOS ORGÁNICOS
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 110796
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 31537
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 31537
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 201100019
Patent: Composti organici.
Estimated Expiration: ⤷  Sign Up

Patent: 01100019
Patent: Composti organici
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 476
Patent: DERIVATI 1-((5-HETEROARILTIAZOL-2-IL)AMINOKARBONIL)PIROLIDIN-2-KARBOKSAMIDA KAO INHIBITORI FOSFATIDILINOZITOL 3-KINAZE (PI3K) KORISNI U TRETMANU PROLIFERATIVNIH OBOLJENJA (1-((5-HETEROARYLTHIAZOL-2-YL)AMINOCARBONYL)PYRROLIDINE-2-CARBOXAMIDE DERIVATIVES AS PHOSPHATIDYLINOSITOL 3-KINASE (PI3K) INHIBITORS USEFUL IN THE TREATMENT OF PROLIFERATIVE DISEASES)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 31537
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1100699
Patent: ORGANIC COMPOUNDS
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1290844
Estimated Expiration: ⤷  Sign Up

Patent: 110038737
Patent: ORGANIC COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 60673
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 53206
Estimated Expiration: ⤷  Sign Up

Patent: 1014851
Patent: Organic compounds
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 11000053
Patent: ORGANIC COMPOUNDS
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4147
Patent: 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)
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 096
Patent: DERIVADOS DE 2-CARBOXAMIDA - CICLOAMINO - UREA ESPECÌFICOS, SUS SALES FARMACÈUTICAMENTE ACEPTABLES, COMPOSICIONES CONTENIÈNDOLOS, PRO-FARMACOS DE LOS MISMOS, PROCESOS PARA SU PRODUCIÒN Y APLICACIONES
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PIQRAY around the world.

Country Patent Number Title Estimated Expiration
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
Netherlands 301071 ⤷  Sign Up
Cuba 24000 UN DERIVADO 2-CARBOXAMIDA-CICLOAMINO-UREA-TIAZOL-PIRIDILO ⤷  Sign Up
Lithuania C2331537 ⤷  Sign Up
Cyprus 2020037 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PIQRAY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331537 2020037 Norway ⤷  Sign Up PRODUCT NAME: ALPELISIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/20/1455 20200810
2331537 CR 2020 00054 Denmark ⤷  Sign Up PRODUCT NAME: ALPELISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; NAT. REG. NO/DATE: EU/1/20/1455 20200728; FIRST REG. NO/DATE: CH 67359 20200324
2331537 C202030063 Spain ⤷  Sign Up PRODUCT NAME: ALPELISIP O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1455; DATE OF AUTHORISATION: 20200727; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1455; DATE OF FIRST AUTHORISATION IN EEA: 20200727
2331537 47/2020 Austria ⤷  Sign Up PRODUCT NAME: ALPELISIB ODER SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/20/1455 (MITTEILUNG) 20200728; FIRST REGISTRATION: CH 67359 20200324
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
>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.