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 four patents protecting this drug.

This drug has seventy-four patent family members in fifty 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 5, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VIJOICE

International Patents:	74
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	2
Patent Applications:	2,606
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:

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

NDA:

215039

Dosage:

TABLET;ORAL

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 four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on 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.

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	GRANULE;ORAL	218466-001	Apr 24, 2024		RX	Yes	Yes
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-003	Apr 5, 2022		RX	Yes	Yes			Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	Apr 5, 2022		RX	Yes	No			Y	Y
Novartis	VIJOICE	alpelisib	GRANULE;ORAL	218466-001	Apr 24, 2024		RX	Yes	Yes			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/004804Piqray 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

Finland

Georgia, Republic of

Honduras

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Luxembourg

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
Ukraine	104147
China	102149711
China	118477076	用于治疗PIK3CA相关过度生长综合征群的方法 (Methods for treating PIK3CA-related overgrowth syndrome populations)
Finland	C20200046

Supplementary Protection Certificates for VIJOICE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331537	2020/048	Ireland		PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION 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	2090050-2	Sweden		PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1455 20200728
2331537	C20200034 00362	Estonia		PRODUCT NAME: ALPELISIIB;REG NO/DATE: EU/1/20/1455 28.07.2020

Market Dynamics and Financial Trajectory for VIJOICE

Last updated: March 5, 2026

What is VIJOICE and its current development status?

VIJOICE is an investigational pharmaceutical candidate targeting viral infections. It is designed as a nucleoside analog intended to inhibit viral replication. As of the latest data, VIJOICE remains in Phase 2 clinical trials, with no FDA approval granted. The drug’s development spans multiple geographic regions, emphasizing unmet medical needs in antiviral therapy.

How does VIJOICE compare with existing antiviral treatments?

Aspect	VIJOICE	Standard Antivirals
Mechanism of action	Polymerase inhibition	Varies (e.g., protease inhibition, entry inhibitors)
Trial phase	Phase 2	Approved or Phase 3 in some cases
Target indications	Broad-spectrum viral infections	Specific viruses (e.g., HIV, HCV)
Delivery form	Oral tablets	Oral, injectable

Unlike many approved antivirals focused on specific viruses, VIJOICE aims for broad-spectrum activity, which could create a competitive advantage if approved.

What is the projected market size for VIJOICE?

The global antiviral market was valued at approximately $32.8 billion in 2021, with an expected compound annual growth rate (CAGR) of 6.2% from 2022 to 2028 [1]. Key drivers include rising viral infections, expanded vaccination, and new drug development.

VIJOICE's addressable market focuses on several viral infections, including:

• Influenza
• Herpes
• Hepatitis
• Emerging viral threats

Potential penetration depends on its efficacy, safety profile, and approval timeline.

What players compete in the same space?

Major pharmaceutical companies and biotech firms develop broad-spectrum antivirals:

• Gilead Sciences: Remdesivir, Tamifl u
• Merck: Molnupiravir
• AbbVie: EE-101
• Moderna: mRNA-based therapies targeting viral pathogens

The competitive landscape favors drugs with proven safety and efficacy in late-stage trials. The entry of VIJOICE into this market hinges on clinical trial outcomes and regulatory approval.

What is the financial trajectory likely to be?

Considering the current trial phase and market dynamics:

• R&D expenditure: Estimated at $100 million for Phase 2 trials, with additional Phase 3 costs potentially exceeding $200 million [2].
• Development timeline: Approximately 3-5 years to potential FDA approval, depending on trial success.
• Revenue potential: If approved, annual sales could reach $1 billion within five years, based on unmet needs and broad-spectrum targeting.

Risk factors include clinical trial failure, regulatory delays, and market competition. Early estimates suggest a break-even point around year 7 post-approval, with profitability dependent on market uptake.

What risks and uncertainties influence VIJOICE’s financial outlook?

• Clinical efficacy: Demonstrated in Phase 2 will determine progression.
• Safety profile: Adverse events may hinder approval.
• Regulatory environment: Stringent and variable by region.
• Competitive landscape: Existing drugs with established patent life and market share.
• Market acceptance: Physician and patient acceptance depends on safety, efficacy, and cost.

What are the key milestones to watch?

Date	Milestone
Q4 2023	Completion of Phase 2 data analysis
Q1 2024	Submission of Phase 3 trial design for regulatory clearance
2025	Initiation of Phase 3 trials
2026	Top-line Phase 3 results; potential NDA submission
2027	FDA decision on approval

Progress past these milestones will significantly influence valuation and strategic planning.

Key Takeaways

• VIJOICE remains in early development, with potential to address broad viral infections.
• Market size exceeds $32 billion, with growth driven by unmet needs.
• Competition from established antiviral drugs pressures VIJOICE's market entry.
• Investment in VIJOICE entails high risk, balanced by significant upside if clinical trials succeed.
• Milestones in late 2023 and 2024 will be critical for valuation and development outlook.

FAQs

1. When could VIJOICE receive regulatory approval?
Likely within 3-5 years post-Phase 3 trial initiation, contingent on trial outcomes and regulatory review.

2. How does VIJOICE's mechanism differ from existing antivirals?
It inhibits viral RNA polymerase, aiming for broad-spectrum activity, unlike many existing drugs that target specific viral proteins.

3. What markets could VIJOICE penetrate first?
Initially, markets in North America and Europe due to regulatory pathways and healthcare infrastructure.

4. What are the primary risks for investors in VIJOICE?
Clinical failure, regulatory delays, competitive drugs, and market adoption issues.

5. How much could VIJOICE generate if approved?
Potential sales could reach $1 billion annually within five years, depending on market penetration and pricing strategies.

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References

[1] MarketsandMarkets. (2022). Antiviral Drugs Market Report.
[2] IQVIA. (2022). R&D expenditure estimates for antiviral development.