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Last Updated: March 29, 2024

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VIJOICE Drug Patent Profile


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Which patents cover Vijoice, and what generic alternatives are available?

Vijoice 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 VIJOICE is alpelisib. One supplier is listed for this compound. Additional details are available on the alpelisib profile page.

DrugPatentWatch® Generic Entry Outlook for Vijoice

Vijoice 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 VIJOICE
International Patents:58
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 74
Clinical Trials: 2
Patent Applications: 1,074
Drug Prices: Drug price information for VIJOICE
What excipients (inactive ingredients) are in VIJOICE?VIJOICE excipients list
DailyMed Link:VIJOICE at DailyMed
Drug patent expirations by year for VIJOICE
Drug Prices for VIJOICE

See drug prices for VIJOICE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VIJOICE
Generic Entry Date for VIJOICE*:
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 VIJOICE

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

SponsorPhase
Celcuity, Inc.Phase 3

See all VIJOICE clinical trials

US Patents and Regulatory Information for VIJOICE

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIJOICE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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 VIJOICE

Pyrrolidine-1,2-dicarboxamide derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pyrrolidine-1,2-dicarboxamide derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting VIJOICE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH SEVERE MANIFESTATIONS OF PIK3CA-RELATED OVERGROWTH SPECTRUM (PROS) WHO REQUIRE SYSTEMIC THERAPY
Exclusivity Expiration: ⤷  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
Novartis VIJOICE alpelisib TABLET;ORAL 215039-001 Apr 5, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis VIJOICE alpelisib TABLET;ORAL 215039-002 Apr 5, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis VIJOICE alpelisib TABLET;ORAL 215039-001 Apr 5, 2022 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 VIJOICE alpelisib TABLET;ORAL 215039-002 Apr 5, 2022 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 VIJOICE

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 VIJOICE

When does loss-of-exclusivity occur for VIJOICE?

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

Argentina

Patent: 3369
Estimated Expiration: ⤷  Try a Trial

Patent: 2074
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 09290904
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0918750
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 34819
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 11000504
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2149711
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 51738
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 110059
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0160014
Estimated Expiration: ⤷  Try a Trial

Cuba

Patent: 000
Estimated Expiration: ⤷  Try a Trial

Patent: 110052
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 17078
Estimated Expiration: ⤷  Try a Trial

Patent: 20037
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 31537
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 011000070
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 11010880
Estimated Expiration: ⤷  Try a Trial

El Salvador

Patent: 11003853
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 8863
Estimated Expiration: ⤷  Try a Trial

Patent: 1100447
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 31537
Estimated Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

Honduras

Patent: 11000699
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 56305
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 25884
Estimated Expiration: ⤷  Try a Trial

Patent: 000044
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0976
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 86601
Estimated Expiration: ⤷  Try a Trial

Patent: 12502080
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 21
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 331537
Estimated Expiration: ⤷  Try a Trial

Patent: 2020534
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 1556
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 11002597
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 284
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 604
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 1071
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0754
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 1100049
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 20037
Estimated Expiration: ⤷  Try a Trial

Panama

Patent: 41901
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 110796
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 31537
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 31537
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 201100019
Estimated Expiration: ⤷  Try a Trial

Patent: 01100019
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 476
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 31537
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1100699
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1290844
Estimated Expiration: ⤷  Try a Trial

Patent: 110038737
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 60673
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 53206
Estimated Expiration: ⤷  Try a Trial

Patent: 1014851
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 11000053
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 4147
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 096
Estimated Expiration: ⤷  Try a Trial

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 VIJOICE around the world.

Country Patent Number Title Estimated Expiration
Costa Rica 20110059 COMPUESTOS ORGANICOS ⤷  Try a Trial
Hungary S2000044 ⤷  Try a Trial
Spain 2560673 ⤷  Try a Trial
China 102149711 Organic compounds ⤷  Try a Trial
New Zealand 590754 Pyridin-4-yl substituted 2-carboxamide pyrrolidine-amide urea derivatives and their use in the treatment of phosphatidylinositol 3-kinase mediated diseases ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIJOICE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2331537 PA2020534,C2331537 Lithuania ⤷  Try a Trial PRODUCT NAME: ALPELISIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727
2331537 C202030063 Spain ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: ALPELISIB ODER SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/20/1455 (MITTEILUNG) 20200728; FIRST REGISTRATION: CH 67359 20200324
2331537 C02331537/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ALPELISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67359 24.03.2020
2331537 C20200034 00362 Estonia ⤷  Try a Trial PRODUCT NAME: ALPELISIIB;REG NO/DATE: EU/1/20/1455 28.07.2020
>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.