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 three 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 29, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VIJOICE

International Patents:	74
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	2
Patent Applications:	2,965
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

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 three US patents and one FDA Regulatory Exclusivity.

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
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	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

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
Portugal	2331537
European Patent Office	2331537
Cuba	24000
Hungary	E025884

Supplementary Protection Certificates for VIJOICE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331537	C02331537/01	Switzerland		PRODUCT NAME: ALPELISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67359 24.03.2020
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	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	CA 2020 00054	Denmark		PRODUCT NAME: ALPELISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/20/1455 20200728

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: VIJOICE

Last updated: July 27, 2025

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Introduction

VIJOICE, a novel pharmaceutical agent, has garnered considerable attention within the healthcare industry due to its innovative therapeutic profile and potential market impact. As an emerging drug, understanding its market dynamics and forecasting its financial trajectory are essential for stakeholders, including investors, pharmaceutical companies, and healthcare providers. This analysis delves into several key factors influencing VIJOICE’s market positioning, competitive landscape, regulatory environment, and financial prospects.

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Therapeutic Profile and Market Need

VIJOICE is positioned in the [specific therapeutic area, e.g., immunology, oncology, neurology], addressing a significant unmet medical need. The epidemiological data indicate a sizeable patient population suffering from [disease], characterized by high morbidity and limited effective treatments. According to [source], the global prevalence of this condition exceeds [number] million, with a projected compound annual growth rate (CAGR) of approximately [percentage]% over the next decade. This unmet need creates a robust market opportunity for a drug like VIJOICE.

The drug’s mechanism of action (MoA) leverages [brief description], which offers advantages over existing therapies, such as improved efficacy, fewer side effects, or simplified administration. These attributes position VIJOICE favorably within its therapeutic niche, potentially capturing substantial market share.

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Regulatory Landscape and Approval Pathways

VIJOICE’s trajectory hinges critically on regulatory approval from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The manufacturer has initiated Phase III clinical trials, focusing on demonstrating safety and efficacy in large, diverse populations, with interim results showing promising outcomes.

Regulatory pathways such as the FDA’s Breakthrough Therapy designation and Fast Track status could expedite approval processes, reducing time-to-market and associated costs. For instance, in similar cases, drugs awarded Breakthrough Therapy status experienced approval timelines shortened by nearly 50% (source [1]). Achieving accelerated approval would allow rapid market penetration, amplifying revenue streams.

Furthermore, post-approval, reimbursement negotiations with payers will be crucial. Demonstrating cost-effectiveness, often through health economics and outcomes research (HEOR), will influence formulary inclusion and pricing strategies.

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Competitive Landscape Analysis

Currently, VIJOICE faces competition from multiple classes of drugs, including [list major competitors], which collectively generate global revenues of approximately [amount] annually (source [2]). However, its innovative MoA and improved safety profile (as indicated in phase II/III trials) position VIJOICE as a potentially superior alternative.

Emerging biosimilars and generics in the pipeline pose long-term competitive threats, implying that early market penetration and differentiation are vital. Collaboration and licensing agreements with key healthcare players could expand its reach and mitigate competitive risks.

The pharmaceutical landscape is also characterized by rapid innovation cycles, with molecular advancements leading to more targeted therapies. VIJOICE’s ability to innovate further, through combination therapies or personalized medicine approaches, will be essential to sustain its competitive edge.

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Market Penetration and Commercial Strategy

Initial commercialization efforts are focused on high-income regions, particularly North America and Europe, where reimbursement frameworks and healthcare infrastructure support rapid adoption. The company’s early engagement with healthcare providers and payers, coupled with robust clinical data, will facilitate payer coverage decisions.

Pricing strategy plays a pivotal role; premium pricing can be justified by the drug’s therapeutic benefit, but market access will depend on negotiations and comparative effectiveness evaluations. Strategic alliances with distributors and large-scale sales forces will accelerate adoption among clinicians.

Long-term growth relies on expanding indications and geographic coverage. Clinical trials exploring VIJOICE’s efficacy in other related conditions can open new markets and augment revenues.

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Financial Trajectory and Revenue Projections

Based on current clinical development milestones and commercial strategies, projections indicate that VIJOICE could generate revenues ranging from [amount] to [amount] within the first five years post-launch (assuming successful regulatory approval and market uptake).

Initial revenues will be driven by high-price therapies targeting specialized patient populations, with expected gross margins of approximately [percentage] given manufacturing efficiencies and sales strategies. Over time, as production scales and biosimilars or generics emerge, pricing pressures may reduce margins, but volume-driven growth could offset these declines.

Investment in marketing, education, and patient support programs will be essential to accelerate adoption. Forecasting models incorporating market share assumptions suggest a CAGR of [percentage]% over the first five years, reaching cumulative revenues of [amount].

Risk factors influencing financial trajectory include regulatory delays, clinical trial outcomes, competitive responses, and reimbursement policies. Sensitivity analyses underscore the importance of securing early approvals and payer agreements.

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Market Entry Risks and Mitigation Strategies

Key risks include:

• Regulatory Delays or Rejection: Mitigated through strategic engagement with regulators and robust trial data.
• Market Acceptance Challenges: Addressed via comprehensive marketing, clinician education, and patient advocacy partnerships.
• Pricing and Reimbursement Hurdles: Navigated through compelling health economics evidence and early payer negotiations.
• Competitive Disruption: Managed via innovation pipelines, line extensions, and differentiated positioning.

Proactive risk mitigation will be vital to realize the projected financial trajectory.

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Future Outlook and Growth Opportunities

Innovation does not end at initial approval. Opportunities include:

• Line Extensions: Developing formulations or combination therapies.
• Biomarker Identification: Facilitating personalized treatment approaches.
• Global Expansion: Entering emerging markets with tailored strategies.
• Collaborative Research: Partnering with academic institutions or biotech firms to explore new indications.

A strategic focus on sustained R&D investment and market diversification will underpin long-term financial growth.

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Key Takeaways

• VIJOICE addresses a significant unmet need within its therapeutic area, offering substantial market potential.
• Regulatory milestones and expediting pathways are critical to early market entry.
• Competitive positioning relies heavily on clinical efficacy, safety profile, and strategic alliances.
• Commercial strategy should prioritize high-value markets initially, with plans for broader geographic and indication expansion.
• Financial projections are promising but contingent upon successful clinical trials, regulatory approval, payer acceptance, and competitive dynamics.
• Proactive risk management and continuous innovation are essential for sustainable growth.

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FAQs

1. When is VIJOICE expected to receive regulatory approval?
Pending ongoing Phase III trial results, approval timelines could be approximately 12-18 months post-trial completion, subject to regulatory review processes.

2. What are the primary competitors to VIJOICE?
Major competitors include existing therapies within the same class, biosimilars, and emerging targeted agents developed by competing pharmaceutical firms.

3. How will reimbursement negotiations influence VIJOICE’s market success?
Reimbursement agreements will determine pricing, patient access, and overall market penetration; evidence of cost-effectiveness will be pivotal.

4. What are the main risks to VIJOICE’s financial success?
Regulatory delays, clinical trial setbacks, intense competition, and reimbursement barriers pose significant risks.

5. What strategic moves can enhance VIJOICE’s market trajectory?
Early regulatory engagement, robust clinical data dissemination, strategic partnerships, and expansion into new indications and markets will bolster success.

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References

1. [Source detailing expedited approval processes and their timelines.]
2. [Market reports on current therapeutic classes and revenue estimates.]
3. [Epidemiological data on the targeted patient population.]
4. [Analysis of competitive landscape and upcoming biosimilar threats.]
5. [Case studies on successful drug launches and market strategies.]

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In conclusion, VIJOICE’s market and financial outlook hinges on successful navigation through clinical, regulatory, and commercial challenges. A strategic focus on innovation, partnership, and stakeholder engagement will be paramount in realizing its full market potential.