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:	66
Clinical Trials:	13
Patent Applications:	17
Drug Prices:	Drug price information 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

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.

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
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes				Y
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes			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
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009

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
Argentina	075926	CRISTALES MOLECULARES DE ACIDO CARBOXILICO DE FLUOROQUINOLONA
Australia	2008228941	Fluoroquinolones for treating, reducing, ameliorating, or preventing infections caused by antibacterial drug-resistant bacteria
European Patent Office	1588702
Japan	2004529199
Portugal	1165058
South Korea	20130010131	FLUOROQUINOLONES FOR TREATING, REDUCING, AMELIORATING, OR PREVENTING INFECTIONS CAUSED BY ANTIBACTERIAL DRUG-RESISTANT BACTERIA
Taiwan	201038536	Fluoroquinolone carboxylic acid molecular crystals

Market Dynamics and Financial Trajectory for BESIVANCE

Introduction to BESIVANCE

BESIVANCE, also known as besifloxacin ophthalmic suspension, is an antibiotic eye drop used to treat bacterial conjunctivitis. It is part of the broader ophthalmic drugs market, which is experiencing significant growth driven by various factors.

Ophthalmic Drugs Market Overview

The global ophthalmic drugs market is projected to grow substantially over the next few years. As of 2023, the market size was estimated at USD 37.82 billion and is expected to grow at a CAGR of 8.34% from 2024 to 2030, reaching USD 66.06 billion by 2030[4].

Key Drivers of Market Growth

Several factors are driving the growth of the ophthalmic drugs market, including:

• Rising Prevalence of Eye Diseases: The increasing prevalence of retinal disorders, such as age-related macular degeneration and diabetic macular edema, is a significant driver. Anti-VEGF agents, which are crucial in treating these conditions, accounted for 32.71% of the global revenue in 2023[4].
• Advancements in Drug Delivery: Innovations in drug delivery mechanisms, including gene therapies, are enhancing the effectiveness and appeal of ophthalmic drugs[4].
• Increasing Investment: Public and private organizations are investing heavily in research and development, further propelling market growth. For example, the National Eye Institute announced a funding of USD 2.5 million for glaucoma treatment research in July 2023[4].

Regional Market Dynamics

The ophthalmic drugs market is geographically diverse, with different regions contributing to its growth:

• North America: This region dominated the market with a share of 44.99% in 2023, driven by a high disease burden, consumer awareness, and proactive government measures[4].
• Asia-Pacific: Expected to grow at a CAGR of 5.65%, this region has the largest patient population but the lowest treatment rate, which is anticipated to drive market growth. Local businesses and strategic actions by market participants are also fostering regional expansion[1].

Market Segmentation

The ophthalmic drugs market is segmented based on drug class, disease, route of administration, and other factors:

• Anti-VEGF Agents: These agents are leading the market due to their effectiveness in treating retinal disorders. Bayer AG's submission for regulatory approval of aflibercept 8 mg in February 2023 is a recent example of innovation in this segment[4].
• Generic Drugs: The generic drugs segment is expected to witness the fastest growth rate due to cost-effectiveness and patent expiry of branded drugs. Government initiatives to promote generic drugs are also supporting this segment[4].

Financial Performance of Key Players

Major pharmaceutical companies are playing a significant role in the ophthalmic drugs market:

• Pfizer: While Pfizer's overall revenues declined in 2023 due to the decrease in Comirnaty and Paxlovid revenues, the company saw operational revenue growth of 7% excluding these contributions. New product launches and in-line product growth drove this increase[2].
• Bayer AG: Bayer's submission for aflibercept 8 mg and other initiatives indicate the company's commitment to the ophthalmic drugs market. Such moves are expected to contribute to the financial growth of these companies[4].

BESIVANCE Specifics

BESIVANCE, as a product within the ophthalmic antibiotics segment, benefits from the overall growth trends in the market:

• Market Position: As an antibiotic eye drop, BESIVANCE competes in a segment that is driven by the need for effective treatments for bacterial conjunctivitis.
• Sales Performance: While specific sales data for BESIVANCE is not provided in the sources, its performance would be influenced by the broader market trends. The increasing prevalence of eye infections and advancements in antibiotic treatments are likely to support its sales.

Challenges and Opportunities

Despite the positive growth trajectory, there are challenges and opportunities to consider:

• Competition: The ophthalmic drugs market is highly competitive, with multiple players including Bausch & Lomb, Novartis AG, and Regeneron Pharmaceuticals. BESIVANCE must compete effectively in this landscape[4].
• Regulatory Approvals: Securing and maintaining regulatory approvals is crucial. For instance, the approval of biosimilars like Byooviz (SB-11) by the U.S. FDA in September 2021 highlights the importance of regulatory support[4].

Innovation and Research

Continuous innovation and research are vital for the growth of ophthalmic drugs like BESIVANCE:

• Gene Therapies: The emergence of gene therapies as a potent drug-delivery mechanism is a significant driver of the market. Companies are investing in research to develop novel therapeutics, which could include new formulations or delivery methods for existing drugs like BESIVANCE[4].

End-User Concentration

The distribution and use of ophthalmic drugs are influenced by end-user preferences:

• Hospitals and Clinical Laboratories: Hospitals are preferred for care due to the availability of various services under one roof. The presence of a well-distributed network of clinical laboratories and hospitals enables better market penetration of ophthalmic drugs[4].

Key Takeaways

• The ophthalmic drugs market is growing rapidly, driven by rising prevalence of eye diseases, advancements in drug delivery, and increasing investment in research.
• BESIVANCE, as an antibiotic eye drop, benefits from these broader market trends.
• Regional dynamics, especially in North America and Asia-Pacific, play a significant role in market growth.
• Major pharmaceutical companies are driving innovation and financial growth in the market.

FAQs

1. What is the projected growth rate of the ophthalmic drugs market?

   • The ophthalmic drugs market is projected to grow at a CAGR of 8.34% from 2024 to 2030[4].

2. Which region dominates the ophthalmic drugs market?

   • North America dominated the market with a share of 44.99% in 2023[4].

3. What are the key drivers of the ophthalmic drugs market growth?

   • The key drivers include the rising prevalence of eye diseases, advancements in drug delivery, and increasing investment in research[4].

4. Which segment is expected to witness the fastest growth rate in the ophthalmic drugs market?

   • The generic drugs segment is expected to witness the fastest growth rate due to cost-effectiveness and patent expiry of branded drugs[4].

5. What role do hospitals and clinical laboratories play in the ophthalmic drugs market?

   • Hospitals and clinical laboratories are preferred for care due to the availability of various services under one roof, enabling better market penetration of ophthalmic drugs[4].

Cited Sources:

1. Straits Research: Ophthalmic Drugs Market Size to Grow at a CAGR of 7.4% by 2030[1].
2. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance[2].
3. NCBI: MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs[3].
4. Grand View Research: Ophthalmic Drugs Market Size & Share | Industry Report 2030[4].
5. GSK: Press release - Full-year and fourth quarter 2022[5].