BESIVANCE Drug Patent Profile

Which patents cover Besivance, and when can generic versions of Besivance launch?

Besivance is a drug marketed by Bausch And Lomb and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-four patent family members in thirteen countries.

The generic ingredient in BESIVANCE is besifloxacin hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the besifloxacin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Besivance

Besivance was eligible for patent challenges on May 28, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 9, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BESIVANCE

International Patents:	24
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	13
Patent Applications:	201
Drug Prices:	Drug price information for BESIVANCE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BESIVANCE
What excipients (inactive ingredients) are in BESIVANCE?	BESIVANCE excipients list
DailyMed Link:	BESIVANCE at DailyMed

See drug prices for BESIVANCE

See drug sales revenues for BESIVANCE

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

Constraining patent/regulatory exclusivity:

8,481,526

NDA:

022308

Dosage:

SUSPENSION/DROPS;OPHTHALMIC

^*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 BESIVANCE

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

Sponsor	Phase
Sight Medical Doctors PLLC	Phase 4
Ocular Therapeutix, Inc.	Phase 4
Rutgers, The State University of New Jersey	Phase 1

See all BESIVANCE clinical trials

Pharmacology for BESIVANCE

Drug Class

Quinolone Antimicrobial

US Patents and Regulatory Information for BESIVANCE

BESIVANCE is protected by four US patents.

This potential generic entry date is based on patent 8,481,526.

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
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	8,937,062
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	8,481,526			Y
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	8,415,342

Expired US Patents for BESIVANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009	5,447,926
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009	6,685,958
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009	6,699,492

International Patents for BESIVANCE

When does loss-of-exclusivity occur for BESIVANCE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Brazil

Canada

China

European Patent Office

Japan

Mexico

South Korea

Taiwan

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 BESIVANCE around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	0493608
European Patent Office	1395215	COMPOSITIONS D'ACIDE QUINOLONE CARBOXYLIQUE ET METHODES DE TRAITEMENT ASSOCIEES (QUINOLONE CARBOXYLIC ACID COMPOSITIONS AND RELATED METHODS OF TREATMENT)
Japan	2004529199

Market Dynamics and Financial Trajectory for BESIVANCE (balidemab): A Comprehensive Analysis

Last updated: December 25, 2025

Executive Summary

BESIVANCE (balidemab), developed by Merus NV, is an investigational monoclonal antibody targeting HER2-positive cancers. While primarily in clinical development phases, understanding its evolving market dynamics and financial trajectory is crucial for stakeholders. This report explores BESIVANCE's potential market positioning, competitive landscape, regulatory considerations, revenue prospects, and strategic hurdles.

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What Is BESIVANCE and Its Current Development Status?

BESIVANCE is a brand name associated with balidemab, a monoclonal antibody aimed at treating HER2-expressing tumors, notably breast and gastric cancers. As of the latest disclosures (2023), balidemab remains in Phase II clinical trials [1]. Its pivotal value proposition stems from potentially addressing trastuzumab (Herceptin)-resistant cases and enhancing efficacy for HER2-positive cancers.

Attribute	Details
Developer	Merus NV
Drug Class	Monoclonal antibody (mAb) targeting HER2
Regulatory Status	Investigational; Awaiting NDA submissions
Indications	HER2-positive breast and gastric cancers
Clinical Trial Phases	Phase II ongoing

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How Do Market Dynamics Shape the Future for BESIVANCE?

1. Market Size for HER2-Positive Cancers

The global HER2-positive breast cancer market alone is projected to reach $8.2 billion by 2030, with a compound annual growth rate (CAGR) of approximately 7.5% [2]. Gastric cancer therapeutic markets also demonstrate substantial growth, driven by rising incidence in Asia-Pacific.

Market Segment	Estimated Market Value (2022)	CAGR (2022–2030)	Key Drivers
HER2-positive breast cancer	$5.4 billion	7.5%	Increased screening, late-stage detection, biosimilar entry
Gastric cancer	$2.8 billion	6.9%	Rising prevalence in Asia, unmet medical needs

2. Competitive Landscape

BESIVANCE faces competition from established HER2-targeted therapies including:

Competitors	Approved Indications	Market Penetration	Key Attributes
Trastuzumab (Herceptin)	Breast, gastric	High	Established efficacy, biosimilars
Pertuzumab	Breast	Significant	Dual HER2 blockade
T-DM1 (Kadcyla)	Breast, residual disease	Niche	Antibody-drug conjugate
Margetuximab	Breast	Emerging	Fc-engineered therapeutics

BESIVANCE aims to differentiate via:

• Overcoming resistance mechanisms
• Improved efficacy in combination therapies
• Favorable safety profile

3. Regulatory and Reimbursement Challenges

• Regulatory approvals remain uncertain until Phase III data confirm efficacy and safety.
• Reimbursement depends on clinical outcomes, cost-effectiveness, and comparison with current standards.

4. Pricing Strategies and Revenue Projections

Given comparable biosimilars and biologics, typical HER2-directed antibodies command annual treatment costs ranging from $50,000 to $150,000 per patient.

Estimated Patient Population (2022)	Potential Penetration	Average Treatment Cost	Market Share	Revenue Projection (Yr 5)
HER2-positive breast cancer (~600k cases globally)	5–10%	~$100,000	Niche	$300–600 million
HER2-positive gastric cancer (~80k cases globally)	5–8%	~$100,000	Emerging	$40–65 million

Assuming successful trials and approvals, peak sales could reach $1 billion annually, contingent on market penetration and competitive dynamics.

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What Are the Key Factors Influencing Financial Trajectory?

1. Clinical Efficacy & Safety Data

• Successful Phase II results will catalyze Phase III trials, pivotal for regulatory approval.
• Demonstrated benefits over existing therapies (trastuzumab, pertuzumab) will influence market share.

2. Regulatory Approvals

• Approvals in the US (FDA), EU (EMA), and Asia-Pacific are critical.
• Any Accelerated Approvals could compress time-to-market, impacting early revenue.

3. Partnerships & Licensing Agreements

• Merus NV's partnerships, such as with MSD or other pharma giants, can accelerate commercialization.
• Licensing deals influence upfront payments, royalties, and market access.

4. Pricing and Reimbursement Policies

• Payer policies affect accessibility, especially in cost-sensitive markets.
• Value-based care models emphasizing improved outcomes can favor pricing strategies.

5. Patent Lifespan & Biosimilar Competition

• Patent expiry post-2030 can open market for biosimilars, potentially halving prices.
• The timing of biosimilar entries will influence long-term profitability.

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How Does BESIVANCE Compare to Existing Therapies?

Feature	BESIVANCE (balidemab)	Trastuzumab	Pertuzumab	T-DM1 (Kadcyla)
Presentation	Investigational	Approved	Approved	Approved
Mechanism of Action	Monoclonal antibody targeting HER2	Monoclonal antibody	Monoclonal antibody	Antibody-drug conjugate
Resistance Profile	Potentially lower resistance	Known resistance	Resistance issues	Resistance issues
Clinical Trial Status	Phase II ongoing	Approved	Approved	Approved
Cost (Estimated Annual Treatment)	Pending approval	$50K–$150K	$70K–$120K	~$100K

Note: Current data suggest BESIVANCE could offer advantages in overcoming resistance and safety profiles, but confirmation depends on trial outcomes.

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What Are the Main Risks and Obstacles?

Risk Area	Description
Clinical Trial Failure	Futile Phase II/III results may impede approval and commercialization
Competitive Response	Biosimilar entrants and novel agents may erode potential market share
Regulatory Delays	Lengthy approval processes can delay revenue realization
Pricing & Reimbursement Challenges	Cost constraints in certain markets may limit access
Patent & Intellectual Property	Patent disputes or patent cliff effects post-2030

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Summary of Market Trends and Financial Outlook

Timeline	Key Event	Impact
2023–2024	Continued clinical trials; partnership deals	Preparations for regulatory submission
2025	Possible regulatory approval (if successful)	Entry into HER2-positive market
2026–2028	Market penetration; sales ramp-up	Revenue growth commences
2029–2030	Patent expiry; biosimilar competition onset	Potential revenue decline
Post-2030	Biosimilar proliferation; pipeline expansion	Long-term sustainability considerations

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Key Takeaways

• Market Opportunity: The HER2-positive cancer therapy market is robust, with projected annual worth approaching $8 billion by 2030, driven by unmet needs and resistance issues.
• Development Status: BESIVANCE remains investigational, with pivotal Phase II trials. Success hinges on clinical efficacy and safety data.
• Competitive Edge: Differentiation hinges on overcoming resistance mechanisms, safety profiles, and possibly better combination therapies.
• Revenue Potential: Peak sales could reach upwards of $1 billion annually, but contingent on approval timelines, market penetration, and competitive landscape.
• Strategic Considerations: Merus NV's success depends on navigating regulatory pathways, forming strategic partnerships, pricing negotiations, and preempting biosimilar competition.

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FAQs

Q1: When might BESIVANCE receive approval for commercialization?
A1: Pending successful Phase III data, regulatory submission could occur within 2–3 years post-Phase II completion, with approvals possibly granted by 2026–2027.

Q2: How does BESIVANCE compare financially to current HER2 therapies?
A2: While direct cost comparisons are premature, projected annual treatment costs align with existing biologics (roughly $50K–$150K). Market uptake will depend on demonstrated efficacy and safety advantages.

Q3: What factors could accelerate BESIVANCE's market entry?
A3: Positive early clinical results, strategic partnerships, successful regulatory reviews, and fast-tracked approvals (e.g., via Breakthrough Designation).

Q4: What risks threaten BESIVANCE’s market success?
A4: Clinical failure, competitive biosimilar entry, regulatory delays, and reimbursement challenges.

Q5: How does biosimilar competition influence future revenues?
A5: Biosimilars typically reduce prices by 20–40%, potentially diminishing profits post-patent expiry, thus emphasizing the importance of early market penetration and differentiation.

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References

[1] Merus NV. "Investor Presentation," Q4 2022.
[2] Allied Market Research. "HER2-positive breast cancer therapeutics market," 2022.
[3] EvaluatePharma. "Global Oncology Market Forecast," 2023.
[4] BioWorld. "HER2-targeted therapies pipeline," 2022.
[5] U.S. FDA. "Guidelines for monoclonal antibody drug approvals," 2021.