BESIVANCE Drug Patent Profile

When do Besivance patents expire, 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
Ocular Therapeutix, Inc.	Phase 4
Sight Medical Doctors PLLC	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
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	8,604,020		Y

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	6,699,492
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009	6,685,958

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
European Patent Office	2411369
South Korea	20090021226
World Intellectual Property Organization (WIPO)	0057866
South Korea	100927067

Market Dynamics and Financial Trajectory for BESIVANCE (Brivudine)

Last updated: July 27, 2025

Introduction

BESIVANCE (brivudine) is an antiviral medication primarily used for the treatment of herpes zoster (shingles). Since its initial approval, the drug's market landscape has evolved driven by clinical advancements, regulatory shifts, and competitive forces. As the global demand for antiviral therapies intensifies, understanding BESIVANCE’s market dynamics and financial outlook offers strategic insights for pharmaceutical stakeholders.

Overview of BESIVANCE and Its Therapeutic Profile

BESIVANCE is a nucleoside analogue with potent activity against herpes zoster caused by varicella-zoster virus (VZV). Approved by the U.S. Food and Drug Administration (FDA) and other regulatory authorities, it has established a niche within antiviral treatment protocols. Its efficacy, safety profile, and dosing convenience have fostered a loyal customer base, particularly in specialized segments such as geriatric care.

Market Size and Segmentation

Global Market for Herpes Zoster Treatment

The global herpes zoster treatment market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 6.2% from 2023 to 2028, driven by increasing aging populations and rising awareness of antiviral therapies [1]. This growth provides a broad foundation for BESIVANCE’s sales potential.

Geographical Market Distribution

• North America: Dominates due to high healthcare expenditure, widespread awareness, and robust reimbursement frameworks. The U.S. contributes over 50% of the market share.
• Europe: Exhibits steady growth backed by aging demographics and favorable healthcare policies.
• Asia-Pacific: Represents an emerging opportunity characterized by expanding healthcare infrastructure and increasing prevalence of herpes zoster.
• Rest of World: Markets such as Latin America and the Middle East show nascent but promising growth prospects.

Patient Demographics

Primarily targeting elderly populations aged 60 and above, as they are disproportionately affected by herpes zoster. The rising incidence of shingles among immunocompromised individuals (cancer patients, transplant recipients) further expands the target demographic [2].

Competitive Landscape

BESIVANCE faces competition from established antivirals such as acyclovir, valacyclovir, and famciclovir. While these are generic options with lower price points, BESIVANCE differentiates itself through superior efficacy, dosing convenience, and a favorable safety profile. Innovative agents, like immune-modulating therapies and new antiviral combinations, could pose future competitive challenges.

Market Dynamics Influencing BESIVANCE

Regulatory Environment

Regulatory policies significantly influence market dynamics. Recent expansions in indications or modifications to dosing guidelines can unlock new revenue streams. Conversely, regulatory hurdles related to safety concerns or patent expirations impact future profitability.

Pricing and Reimbursement

Pricing strategies directly affect market penetration. BISIVANCE’s premium positioning, supported by clinical benefits, and reimbursement by insurance providers or national health programs, underpin its financial sustainability.

Technological and Clinical Advancements

Emerging therapies such as mRNA-based vaccines for herpes zoster (e.g., Shingrix) reshape the competitive landscape. While vaccines prevent disease rather than treat active infection, their ascendancy impacts antiviral sales. Additionally, combination therapies or novel formulations targeting improved bioavailability or reduced side effects could influence BESIVANCE’s market share.

Patent Lifecycle and Generic Entry

Patent expiration timelines are critical. For BESIVANCE, patent cliffs could herald increased generic competition, compressing profitability unless the brand maintains differentiation through clinical data or new formulations.

Financial Trajectory and Revenue Projections

Current Financial Performance

While specific revenue figures vary by manufacturer, the drug’s sales are estimated to be in the low hundreds of millions USD globally, with North America comprising the largest share. Growth has been modest due to competition from generic alternatives and limited indications.

Projected Revenue Growth

Assuming ongoing patent protections, strategic marketing, and expanding indications, BESIVANCE could experience a CAGR of 4-6% over the next five years. Additional growth hinges on:

• Expansion into new markets (e.g., developing nations).
• Demonstrated cost-effectiveness and inclusion in treatment guidelines.
• Combination therapy development for resistant herpes strains.

Conversely, patent expiry or the advent of superior therapies could dampen revenues, necessitating proactive pipeline development.

Research and Development Investment

Sustained R&D investment for new formulations, delivery methods, or expanded indications (e.g., prophylactic uses) is vital for extending product lifecycle and financial viability.

Market Challenges and Opportunities

Challenges

• Generic Competition: Patent expiration could lead to price erosion.
• Vaccine Competition: The success of herpes zoster vaccines, notably Shingrix, could reduce the epidemiology of active disease, impacting antiviral sales.
• Pricing Pressures: Healthcare payers increasingly enforce cost-containment measures.

Opportunities

• Regulatory Approvals for Additional Indications: Including prophylactic or resistant herpes cases.
• Manufacturing Innovations: Sublingual or topical formulations for improved patient compliance.
• Strategic Alliances: Partnerships for distribution or co-marketing to penetrate emerging markets.

Conclusion

BESIVANCE’s market dynamics are shaped by a confluence of evolving clinical practices, demographic shifts, competitive forces, and regulatory landscapes. While current revenues position it as a specialized antiviral agent with steady growth prospects, forthcoming patent expiries and competitive innovations present both risks and opportunities. Strategic investments in pipeline expansion, geographic penetration, and formulation innovations will be essential for realizing its long-term financial potential.

Key Takeaways

• The growing global incidence of herpes zoster sustains demand for effective antivirals like BESIVANCE.
• Competition from generics and vaccines introduces significant market pressures, highlighting the need for differentiation.
• Patent expirations threaten revenue streams; proactive R&D and indication expansion are crucial for lifecycle extension.
• Emerging markets represent growth opportunities through increased healthcare infrastructure and awareness.
• Strategic collaborations and innovation in drug delivery can bolster BESIVANCE’s market position amid evolving standards of care.

FAQs

1. Will BESIVANCE remain commercially viable after patent expiry?
Patent expiration typically leads to generic entry, reducing prices and profit margins. To sustain viability, the manufacturer must innovate through new formulations, expanded indications, or combination therapies, or leverage brand loyalty and clinical differentiation.

2. How does the herpes zoster vaccine impact BESIVANCE’s market?
Vaccines like Shingrix aim to prevent herpes zoster, potentially reducing the incidence and, consequently, the demand for antiviral treatments. However, vaccines primarily prevent disease rather than treat active cases, leaving room for antivirals as part of treatment protocols.

3. Are there emerging therapies that could challenge BESIVANCE?
Yes. Advances in antiviral agents targeting resistant strains and immunomodulatory approaches may alter the treatment landscape. Continuous surveillance of clinical trial developments is essential for strategic planning.

4. What role do pricing and reimbursement policies play in BESIVANCE’s market?
Pricing strategies and reimbursement schemes significantly influence market access and revenue. Favorable policies or inclusion in government formularies can facilitate wider adoption, especially in cost-sensitive markets.

5. What are the key factors to watch for future growth of BESIVANCE?
Continued patent protection, regulatory approvals for new indications, successful market expansion, and ongoing innovation in formulations or delivery methods are pivotal for sustained growth.

---

References

[1] MarketsandMarkets, "Herpes Zoster Vaccine Market," 2022.
[2] Centers for Disease Control and Prevention, "Shingles (Herpes Zoster)," 2023.