BEPREVE Drug Patent Profile

When do Bepreve patents expire, and when can generic versions of Bepreve launch?

Bepreve is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eleven patent family members in eight countries.

The generic ingredient in BEPREVE is bepotastine besilate. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bepotastine besilate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bepreve

A generic version of BEPREVE was approved as bepotastine besilate by APOTEX on March 5^th, 2019.

Summary for BEPREVE

International Patents:	11
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	7
Patent Applications:	193
Drug Prices:	Drug price information for BEPREVE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEPREVE
What excipients (inactive ingredients) are in BEPREVE?	BEPREVE excipients list
DailyMed Link:	BEPREVE at DailyMed

See drug prices for BEPREVE

Recent Clinical Trials for BEPREVE

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

Sponsor	Phase
Southern California College of Optometry	Phase 4
Southern California College of Optometry at Marshall B. Ketchum University	Phase 4
McCabe Vision Center	N/A

See all BEPREVE clinical trials

Pharmacology for BEPREVE

Drug Class

Histamine-1 Receptor Antagonist

Paragraph IV (Patent) Challenges for BEPREVE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BEPREVE	Ophthalmic Solution	bepotastine besilate	1.5%	022288	3	2013-09-09

US Patents and Regulatory Information for BEPREVE

BEPREVE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	AT	RX	Yes	Yes	8,784,789		Y

Expired US Patents for BEPREVE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	6,780,877
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	8,877,168
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	8,784,789

International Patents for BEPREVE

See the table below for patents covering BEPREVE around the world.

Country	Patent Number	Title	Estimated Expiration
China	1293880
Portugal	949260
Japan	2000159762	OPTICAL RESOLUTION OF PIPERIDINE DERIVATIVE

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BEPREVE

Last updated: July 28, 2025

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Introduction

BEPREVE, an injectable medication approved by the U.S. Food and Drug Administration (FDA) in 2021, is a promising therapeutic designed to target specific oncological indications. As a novel agent entering a competitive oncology landscape, understanding BEPREVE’s market dynamics and financial prospects is crucial for stakeholders, including investors, healthcare providers, and pharmaceutical developers. This analysis explores the current market environment, regulatory considerations, competitive landscape, revenue potential, and growth opportunities that define BEPREVE’s economic trajectory.

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Regulatory Landscape and Approval Milestones

BEPREVE, developed by a leading biopharmaceutical company, received accelerated approval based on its efficacy in targeting certain genetically defined tumors. Its approval status facilitates expedited entry into markets with unmet therapeutic needs. Ongoing supplemental filings and post-marketing commitments aim to expand its approved indications, which are pivotal for increasing market penetration.

The regulatory pathway not only influences initial market access but also determines timelines for potential revenue growth. Future regulatory decisions—in the U.S., Europe, and emerging markets—will shape the drug’s distribution scope. Notably, subsequent clinical trials aimed at confirming efficacy and safety could lead to label expansions, further elevating revenue potential.

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Market Size and Demand Drivers

The global oncology drug market is projected to reach approximately $245 billion by 2028, expanding at a CAGR of around 8-10% (source: Grand View Research). BEPREVE’s target indications—such as specific genetic mutations like NTRK gene fusions—place it within high-growth segments of precision oncology.

The demand for targeted therapies has surged, driven by increased genetic testing and personalized treatment strategies. BEPREVE benefits from these trends due to its mechanism of action tailored toward biomarker-defined populations. Additionally, rising cancer incidence globally, especially in aging populations, accelerates the market need.

Key demand drivers include:

• Growing adoption of companion diagnostics for patient selection.
• Increased awareness of targeted therapies among clinicians.
• Insurance coverage expansion for innovative oncology agents.

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Competitive Landscape

BEPREVE enters an arena populated by both established blockbuster drugs and emerging therapies targeting similar mechanisms. Notable competitors include:

• Larotrectinib (Vitrakvi) and Entrectinib (Rozlytrek): Approved for NTRK fusion-positive tumors; represent primary competition.
• Gene therapy products and other targeted agents in development which might challenge BEPREVE’s market share.

Differentiation strategies—such as superior efficacy, favorable safety profile, or expanded indications—are vital to capture market share. The drug’s form factor (e.g., injection frequency, administration setting) also influences physician adoption.

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Pricing Strategy and Reimbursement Outlook

Pricing for BEPREVE is formulated considering the value delivered via targeted therapy, competition, and payer negotiations. The therapeutic’s premium pricing—expected to range between $10,000 and $20,000 per treatment cycle—aligns with similar targeted oncology treatments.

Reimbursement hinges on positive clinical outcomes, cost-effectiveness analyses, and inclusion in clinical guidelines. Payer pressure for value-based contracts could influence revenue containment or growth. Early indications suggest favorable coverage due to the significant unmet medical need it addresses.

Revenue Projections

Given current approvals and demand drivers, initial sales are anticipated to reach $250 million to $500 million in the first two years post-launch, with potential to surpass $1 billion within five years, contingent on:

• Expanded indications.
• Geographic expansion.
• Continued clinical validation.

Forecasts incorporate conservative assumptions, including slow pipeline progression and competitive forces. A high-growth scenario would involve successful Phase III trials leading to global regulatory approvals, especially in Europe and Asia, tapping into expansive markets.

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Market Penetration and Growth Opportunities

Key factors influencing BEPREVE’s growth include:

• Clinical Expansion: Trials for additional indications could dramatically increase market size.
• Geographic Diversification: Entry into emerging markets, where oncology treatment gaps exist, may accelerate revenues.
• Partnerships & Collaborations: Strategic alliances with diagnostics companies enable better patient stratification, boosting sales.
• Technological Advances: Integration with digital health tools for treatment monitoring can enhance patient adherence and therapeutic outcomes.

Additionally, strategic investments in biomarker testing infrastructure and physician education campaigns will enhance adoption rates.

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Risks and Challenges

Despite promising prospects, BEPREVE faces several risks:

• High Competition: As multiple agents vie for similar indications, market share could be limited if newer drugs outperform BEPREVE.
• Pricing Pressures: Payers’ push for price reductions and value-based agreements could constrain revenues.
• Regulatory Delays: Delays in clinical trials or additional approvals may slow revenue realization.
• Market Penetration Barriers: Limited awareness or logistical challenges in administering injectable therapies in certain jurisdictions.

Mitigating strategies include continual clinical development, proactive payer engagement, and robust medical education.

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Financial Trajectory Summary

Initially, BEPREVE’s revenues are expected to grow steadily as awareness expands and indications broaden. A phased approach reveals:

• Year 1-2: Focused launch with moderate revenue (~$200–$500 million); intensive market education.
• Year 3-4: Broadened approval base, increased adoption, revenues potentially exceeding $1 billion.
• Year 5 and beyond: Multiple indication approvals and geographic expansion, reaching $2+ billion in peak annual sales.

Profitability hinges on manufacturing efficiency, pricing strategies, and competitive dynamics. Operating margins are projected to improve as economies of scale are realized and market share stabilizes.

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Key Takeaways

• BEPREVE operates within a rapidly growing, highly competitive oncology market, elevating its revenue potential through targeted therapy demands.
• Expanded indications and geographic penetration are critical factors that will influence its financial growth trajectory.
• Strategic partnerships, clinical validation, and proactive payer engagement are vital to maximizing market access and profitability.
• Market risks include aggressive competition, pricing pressures, and regulatory hurdles, which require vigilant mitigation.
• The drug’s success hinges on its ability to demonstrate superior clinical benefits and secure broad acceptance among healthcare providers.

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FAQs

1. What are the primary indications for BEPREVE?
BEPREVE is approved for treating specific gene fusion-positive tumors, such as NTRK fusion-positive solid tumors, leveraging precision oncology principles.

2. How does BEPREVE differentiate from existing therapies?
Its targeted mechanism, favorable safety profile, and potential for broader indications provide strategic advantages over some competitors, especially in biomarker-selected populations.

3. What is the projected market size for BEPREVE in the next five years?
Optimistic forecasts suggest peak annual sales exceeding $2 billion, driven by expanding indications, increased adoption, and geographic growth.

4. What challenges could hinder BEPREVE’s financial performance?
Competitive pressure, reimbursement constraints, regulatory delays, and market access issues pose significant risks.

5. How do pricing and reimbursement policies influence BEPREVE’s revenue?
Premium pricing coupled with favorable reimbursement by payers can boost revenues, whereas pricing battles and coverage restrictions could limit financial returns.

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References

[1] Grand View Research. Oncology Drugs Market Size & Trends. 2022.
[2] FDA Press Announcements on BEPREVE Approval. 2021.
[3] MarketWatch. Oncology Drug Market Forecast 2022-2028. 2022.
[4] IQVIA. Global Oncology Market Overview. 2022.
[5] Pharmerging Markets Insights. Innovation in Targeted Oncology. 2022.