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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 two NDAs. 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:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	2
Patent Applications:	868
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

Constraining patent/regulatory exclusivity:

8,227,462

NDA:

215039

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

8,227,462

NDA:

218466

Dosage:

GRANULES;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

US Patents and Regulatory Information for VIJOICE

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

This potential generic entry date is based on patent 8,227,462.

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

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	GRANULES;ORAL	218466-001	Apr 24, 2024		RX	Yes	Yes	8,476,268		Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-002	Apr 5, 2022		RX	Yes	No	8,476,268		Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	Apr 5, 2022		RX	Yes	No	8,476,268		Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-003	Apr 5, 2022		RX	Yes	Yes	8,227,462		Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-002	Apr 5, 2022		RX	Yes	No	8,227,462		Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-003	Apr 5, 2022		RX	Yes	Yes

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
Cuba	20110052	COMPUESTOS ORGÁNICOS
World Intellectual Property Organization (WIPO)	2010029082
Costa Rica	20110059	COMPUESTOS ORGANICOS
Dominican Republic	P2011000070	COMPUESTOS ORGANICOS
Colombia	6351738	COMPUESTOS ORGANICOS
Morocco	32604	مركبات عضوية

Supplementary Protection Certificates for VIJOICE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331537	C20200034 00362	Estonia		PRODUCT NAME: ALPELISIIB;REG NO/DATE: EU/1/20/1455 28.07.2020
2331537	PA2020534,C2331537	Lithuania		PRODUCT NAME: ALPELISIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727
2331537	CA 2020 00054	Denmark		PRODUCT NAME: ALPELISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/20/1455 20200728
2331537	20C1055	France		EPRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, REGISTRATION NO/DATE: EU/1/20/1455 20200728
2331537	CR 2020 00054	Denmark		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	PA2020534	Lithuania		PRODUCT NAME: ALPELISIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727

VIJOICE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vijoice (Alpelisib)

Introduction to Vijoice

Vijoice, or alpelisib, is a groundbreaking medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of PIK3CA-Related Overgrowth Spectrum (PROS), a rare genetic condition characterized by atypical overgrowths and blood vessel anomalies. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

FDA Approval and Clinical Significance

Vijoice was granted accelerated approval by the FDA in April 2022, marking a significant milestone for patients with PROS who previously lacked an approved treatment specifically addressing their condition[1][5].

Clinical Efficacy

The approval was based on real-world data from the EPIK-P1 study, which demonstrated that patients treated with Vijoice experienced a reduction in the size of PROS lesions and an improvement in PROS-related signs and symptoms. Specifically, 27% of patients achieved a confirmed response to treatment, defined as a 20% or greater reduction in the sum of PROS target lesion volume[1].

Market Demand and Patient Population

Rare Disease Market

PROS is a rare condition affecting an estimated 14 people per million, making it a niche but critical market for those affected. The lack of previous treatments created a significant unmet need, which Vijoice now addresses[1].

Patient Support Programs

Novartis has implemented robust patient support programs to facilitate access to Vijoice, including financial resources for eligible patients and continued education. This support is crucial for ensuring that patients can benefit from the treatment despite its specialized nature[1].

Financial Performance and Growth

Initial Market Impact

The approval of Vijoice has driven significant interest and adoption. While specific financial figures for Vijoice alone are not detailed in the available sources, the overall performance of Novartis's innovative medicines portfolio, which includes Vijoice, has shown strong growth. For instance, Novartis reported demand-driven growth across various geographies, with the US market seeing a notable increase in sales for their innovative medicines[3].

Long-Term Treatment and Revenue Potential

The clinical evidence for Vijoice has been established over a median of 3.5 years and up to 6 years of treatment. This extended treatment duration indicates a potential for sustained revenue generation. The median duration of treatment with Vijoice was 42 months, with 22.8% of patients treated for more than 60 months. This long-term treatment profile suggests a stable and predictable revenue stream[2].

Competitive Landscape

Unique Market Position

Vijoice holds a unique position as the first and only FDA-approved treatment for PROS. This exclusivity gives Novartis a competitive edge in the rare disease market, particularly for conditions related to PIK3CA mutations[1][5].

European Market Status

Although the application for marketing authorization in the European Union was withdrawn in October 2023 due to unresolved questions from the European Medicines Agency, the FDA approval in the US remains a significant market opportunity for Vijoice[4].

Patient Outcomes and Market Impact

Reduction in Surgeries and Symptom Improvement

The treatment with Vijoice has led to a reduction in the number of surgeries required for most pediatric and adult patients. Additionally, patients experienced improvements in various PROS-related symptoms such as fatigue, limb asymmetry, vascular malformations, and pain. These outcomes not only improve patient quality of life but also reduce the overall healthcare burden associated with managing PROS[2].

Economic Impact

The reduction in surgeries and improvement in symptoms can lead to significant economic benefits, including lower healthcare costs and reduced need for hospitalizations and other medical interventions. This economic impact can further drive the adoption and reimbursement of Vijoice in various healthcare systems.

Challenges and Future Outlook

Regulatory Challenges

The withdrawal of the marketing authorization application in the EU highlights the regulatory challenges that Vijoice may face. However, the FDA approval and ongoing studies to advance the scientific understanding of PROS conditions are positive indicators for the drug's future[4].

Continued Research and Development

Novartis is continuing to invest in studies to understand the full potential of Vijoice and to advance the treatment of PROS conditions. This ongoing research is crucial for maintaining and expanding the market presence of Vijoice[1].

Key Takeaways

• First FDA-Approved Treatment: Vijoice is the first and only FDA-approved treatment for PROS, addressing a significant unmet need in the rare disease market.
• Clinical Efficacy: The drug has shown efficacy in reducing PROS lesions and improving related symptoms, based on real-world data from the EPIK-P1 study.
• Long-Term Treatment: The median treatment duration is 42 months, indicating a potential for sustained revenue generation.
• Unique Market Position: Vijoice holds a unique market position due to its exclusivity in treating PROS.
• Regulatory Challenges: Despite the EU application withdrawal, the FDA approval remains a strong market opportunity.
• Ongoing Research: Continued investment in research to understand the full potential of Vijoice is crucial for its future market trajectory.

FAQs

Q: What is Vijoice, and what is it used for?

A: Vijoice, or alpelisib, is a medication approved by the FDA for the treatment of PIK3CA-Related Overgrowth Spectrum (PROS), a rare genetic condition characterized by atypical overgrowths and blood vessel anomalies.

Q: What was the basis for the FDA approval of Vijoice?

A: The FDA approval was based on real-world data from the EPIK-P1 study, which showed patients treated with Vijoice experienced a reduction in PROS lesions and improvement in related symptoms.

Q: How long do patients typically receive treatment with Vijoice?

A: The median duration of treatment with Vijoice is 42 months, with some patients treated for more than 60 months.

Q: What are the common adverse events associated with Vijoice?

A: The most common adverse events include diarrhea, stomatitis, and hyperglycemia, with cellulitis being the most common grade 3/4 adverse event.

Q: Why was the marketing authorization application for Vijoice withdrawn in the EU?

A: The application was withdrawn due to unresolved questions from the European Medicines Agency, although the FDA approval in the US remains in place.

Sources

1. Novartis Press Release: FDA approves Novartis Vijoice® (alpelisib) as first and only treatment for select patients with PIK3CA-related overgrowth spectrum (PROS)[1].
2. Vijoice-HCP: Efficacy | VIJOICE® (alpelisib) tablets | HCP[2].
3. Novartis Investor Presentation: Q2 2024 Investor Presentation[3].
4. European Medicines Agency: Vijoice | European Medicines Agency (EMA)[4].
5. Pharmacy Practice News: FDA Approves Vijoice as First Treatment for PIK3CA-Related Overgrowth Spectrum[5].