BEPREVE Drug Patent Profile

When do Bepreve patents expire, and what generic alternatives are available?

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:	80
Clinical Trials:	7
Patent Applications:	139
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

International Patents for BEPREVE

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

Country	Patent Number	Title	Estimated Expiration
South Korea	101016595
Japan	2016006059	光学活性ピペリジン誘導体の酸付加塩及びその製法 (OPTICALLY ACTIVE PIPERIDINE DERIVATIVE ACID-ADDITION SALT AND PREPARATION THEREOF)
Japan	2007145852	ACID ADDUCT SALT OF OPTICALLY ACTIVE PIPERIDINE DERIVATIVE AND METHOD FOR PRODUCING THE SAME
Japan	2000159762	OPTICAL RESOLUTION OF PIPERIDINE DERIVATIVE
China	1446812
Japan	2014012732	ACID ADDITION SALT OF OPTICALLY ACTIVE PIPERIDINE DERIVATIVE AND MANUFACTURING METHOD THEREOF
Japan	2012180360	ACID ADDITION SALT OF OPTICALLY ACTIVE PIPERIDINE DERIVATIVE, AND METHOD FOR PRODUCING THE SAME

BEPREVE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bepreve (Bepotastine Besilate Ophthalmic Solution)

Market Overview of Ocular Drugs

The global ocular drug delivery market is experiencing significant growth, driven primarily by the increasing prevalence of ophthalmic disorders. This market is projected to grow from USD 15 billion in 2022 to USD 25.2 billion by 2030, at a CAGR of 6.7% during the forecast period of 2023-2030[1].

Bepreve: A Key Player in the Ocular Drug Market

What is Bepreve?

Bepreve (bepotastine besilate ophthalmic solution) is an antihistamine used to treat allergic conjunctivitis, a common condition characterized by itchy, watery eyes due to allergies.

Market Segment Dominance

The prescription segment, which includes Bepreve, led the largest share of the ocular drug delivery market with a market share of around 62.3% in 2022. This dominance is attributed to the perceived efficacy and safety of prescription drugs over their over-the-counter counterparts[1].

Demand Drivers for Bepreve

Increasing Prevalence of Allergic Conjunctivitis

The rising incidence of allergic conjunctivitis, particularly in regions with high pollen counts and increasing environmental allergens, drives the demand for Bepreve. As public awareness of eye ailments grows, more patients are seeking effective treatments, contributing to the market's expansion[4].

Regulatory Support

New FDA guidelines under the Prescription Drug User Fee Act provide a structured approach to evaluating the risks and benefits of ophthalmic drugs, including Bepreve, in clinical trials. This regulatory framework supports the development and approval of new ophthalmic treatments, further boosting market growth[4].

Financial Performance and Projections

Revenue Contribution

Bepreve, as part of the broader prescription ophthalmic drugs market, contributes significantly to the revenue of pharmaceutical companies. For instance, Bausch Health, a major player in the ophthalmic drugs market, reported substantial revenues from its ophthalmic segment. While specific financial data for Bepreve alone is not detailed, the overall ophthalmic segment's performance indicates a strong financial trajectory[3].

Market Growth Projections

The anti-allergic segment, which includes Bepreve, is expected to grow in line with the overall ophthalmic drugs market. With a CAGR of 6.7% projected for the ocular drug delivery market, Bepreve is likely to see increased sales and revenue over the forecast period[1].

Competitive Landscape

Key Players

Bausch Health, the manufacturer of Bepreve, operates in a competitive landscape that includes other major players such as Pfizer Inc., Alcon, and Harrow Health Inc. The competitive environment is driven by innovation, with companies focusing on developing new treatments and expanding their product portfolios[4].

Strategic Initiatives

Companies like Bausch Health are investing heavily in research and development, direct-to-consumer advertising, and sales force capabilities to enhance their market position. These strategic initiatives are expected to drive growth for Bepreve and other ophthalmic drugs in the portfolio[3].

Regional Market Dynamics

North America

North America is the largest market for ophthalmic drugs, including Bepreve, and is expected to grow at a CAGR of 6.7% during the forecast period. The region's growth is fueled by a high prevalence of eye illnesses and increased public awareness of ocular health[4].

Asia-Pacific

The Asia-Pacific region, while having the largest patient population, has a lower treatment rate, presenting a significant growth opportunity for Bepreve and other ophthalmic drugs. Local companies and strategic partnerships are expected to drive market expansion in this region[4].

Europe

Europe is also expected to see significant growth, driven by increasing consumer awareness and regulatory support. The European Medicines Agency's initiatives to promote new pharmacological treatments for eye diseases further support the market's expansion[4].

Key Takeaways

• Market Growth: The ocular drug delivery market, including Bepreve, is expected to grow at a CAGR of 6.7% from 2022 to 2030.
• Prescription Segment Dominance: The prescription segment, which includes Bepreve, holds the largest market share.
• Demand Drivers: Increasing prevalence of allergic conjunctivitis and regulatory support drive demand for Bepreve.
• Financial Performance: Bepreve contributes to the strong financial performance of its parent company, Bausch Health, within the ophthalmic segment.
• Competitive Landscape: The market is competitive, with major players investing in R&D and marketing initiatives.
• Regional Dynamics: North America, Asia-Pacific, and Europe are key regions driving market growth.

FAQs

What is Bepreve used for?

Bepreve (bepotastine besilate ophthalmic solution) is used to treat allergic conjunctivitis, a condition characterized by itchy, watery eyes due to allergies.

Which segment of the ocular drug delivery market does Bepreve belong to?

Bepreve belongs to the prescription segment, which led the largest share of the ocular drug delivery market in 2022.

What is the projected growth rate of the ocular drug delivery market?

The ocular drug delivery market is expected to grow at a CAGR of 6.7% from 2022 to 2030.

Which region is the largest market for ophthalmic drugs like Bepreve?

North America is the largest market for ophthalmic drugs, including Bepreve.

What are the key drivers of demand for Bepreve?

The increasing prevalence of allergic conjunctivitis and regulatory support are key drivers of demand for Bepreve.

Who are the major players in the ophthalmic drugs market?

Major players include Bausch Health, Pfizer Inc., Alcon, and Harrow Health Inc.

Sources

1. GreyViews: Ocular Drug Delivery Market- Size| Growth| Market Analysis Till 2030
2. Bausch Health: 4Q & FY 2020 - Financial Results - Bausch Health Companies Inc.
3. Bausch Health: 2022 ANNUAL REPORT - Bausch Health Companies Inc.
4. StraitsResearch: Ophthalmic Drugs Market Size to Grow at a CAGR of 7.4% by 2030
5. Bausch Health: 4Q & FY 2021 - Financial Results - Bausch Health Companies Inc.