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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PIQRAY
*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
| Sponsor | Phase |
|---|---|
| Columbia University | Phase 1 |
| Stemline Therapeutics, Inc. | Phase 1/Phase 2 |
| Celcuity, Inc. | Phase 3 |
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 | ||||
| >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 |
|---|---|---|---|
| China | 102149711 | Organic compounds | ⤷ Sign Up |
| Nicaragua | 201100049 | COMPUESTOS ORGÁNICOS. | ⤷ Sign Up |
| South Korea | 101290844 | ⤷ 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 | 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 | SPC/GB20/059 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 67359 20200324; UK EU/1/20/1455(FOR NI) 20200728; UK FURTHER MA ON IPSUM 20200728 |
| 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 |
| >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.
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