VIJOICE Drug Patent Profile

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

Summary for VIJOICE

International Patents:	58
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
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

See drug prices for VIJOICE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIJOICE

NDA:

215039

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

Sponsor	Phase
Celcuity, Inc.	Phase 3

See all VIJOICE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VIJOICE

L01EM	Phosphatidylinositol-3-kinase (Pi3K) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for VIJOICE

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

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

FDA Regulatory Exclusivity protecting VIJOICE

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			Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-002	Apr 5, 2022		RX	Yes	No
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	Apr 5, 2022		RX	Yes	No
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-003	Apr 5, 2022		RX	Yes	Yes
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-002	Apr 5, 2022		RX	Yes	No
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	Apr 5, 2022		RX	Yes	No			Y	Y

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

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Honduras

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Panama

Peru

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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
Argentina	112074	DERIVADOS DE 2-CARBOXAMIDA-CICLOAMINO-UREA COMO INHIBIDORES DE PI-3
Hungary	S2000044
China	102149711	Organic compounds
South Africa	201100699	ORGANIC COMPOUNDS
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
Hong Kong	1156305	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-)))

Supplementary Protection Certificates for VIJOICE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331537	301071	Netherlands		PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/20/1455 20200728
2331537	122020000073	Germany		PRODUCT NAME: ALPELISIB ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/20/1455 20200727; FIRST REGISTRATION: SCHWEIZ 67359 20200324
2331537	C202030063	Spain		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	2090050-2	Sweden		PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1455 20200728
2331537	2020C/547	Belgium		PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728
2331537	47/2020	Austria		PRODUCT NAME: ALPELISIB ODER SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/20/1455 (MITTEILUNG) 20200728; FIRST REGISTRATION: CH 67359 20200324