BEPOTASTINE BESILATE - Generic Drug Details

What are the generic sources for bepotastine besilate and what is the scope of freedom to operate?

Bepotastine besilate is the generic ingredient in two branded drugs marketed by Alembic, Apotex, Mylan, Somerset Theraps Llc, and Bausch And Lomb Inc, and is included in five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bepotastine besilate has eleven patent family members in eight countries.

There are seven drug master file entries for bepotastine besilate. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for BEPOTASTINE BESILATE

International Patents:	11
US Patents:	1
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	23
Patent Applications:	266
Drug Prices:	Drug price trends for BEPOTASTINE BESILATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BEPOTASTINE BESILATE
What excipients (inactive ingredients) are in BEPOTASTINE BESILATE?	BEPOTASTINE BESILATE excipients list
DailyMed Link:	BEPOTASTINE BESILATE at DailyMed

See drug prices for BEPOTASTINE BESILATE

Recent Clinical Trials for BEPOTASTINE BESILATE

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

Sponsor	Phase
Laboratorios Poen	Phase 4
Laboratorios Sophia S.A de C.V.	Phase 1
Dong-A ST Co., Ltd.	N/A

See all BEPOTASTINE BESILATE clinical trials

Generic filers with tentative approvals for BEPOTASTINE BESILATE

Applicant	Application No.	Strength	Dosage Form
		1.5%	SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BEPOTASTINE BESILATE

Drug Class

Histamine-1 Receptor Antagonist

Paragraph IV (Patent) Challenges for BEPOTASTINE BESILATE

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 BEPOTASTINE BESILATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Somerset Theraps Llc	BEPOTASTINE BESILATE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	217770-001	Aug 14, 2024	AT	RX	No	No
Alembic	BEPOTASTINE BESILATE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	214588-001	Apr 5, 2023	AT	RX	No	No
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009	AT	RX	Yes	Yes			Y
Mylan	BEPOTASTINE BESILATE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	206220-001	Mar 18, 2019	AT	RX	No	No
Apotex	BEPOTASTINE BESILATE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	206066-001	Mar 5, 2019	AT	RX	No	No

Expired US Patents for BEPOTASTINE BESILATE

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
Bausch And Lomb Inc	BEPREVE	bepotastine besilate	SOLUTION/DROPS;OPHTHALMIC	022288-001	Sep 8, 2009

International Patents for BEPOTASTINE BESILATE

Country	Patent Number	Title	Estimated Expiration
Japan	WO2004011001	水性液剤および光安定化された水性液剤
China	1612734	Aqueous liquid preparations and light-stabilized aqueous liquid preparations
Spain	2371340
South Korea	101016595
Austria	528003
Japan	3631748
European Patent Office	1525884	PREPARATIONS LIQUIDES AQUEUSES ET PREPARATIONS LIQUIDES AQUEUSES PHOTOSTABILISEES (AQUEOUS LIQUID PREPARATIONS AND LIGHT-STABILIZED AQUEOUS LIQUID PREPARATIONS)

BEPOTASTINE BESILATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Bepotastine Besilate

Introduction to Bepotastine Besilate

Bepotastine besilate is a non-sedating, selective antagonist of the histamine 1 (H1) receptor, primarily used to treat itching associated with allergic conjunctivitis. It is available in ophthalmic and oral forms, with the ophthalmic solution being FDA-approved since September 2009 under the brand name Bepreve[5].

Market Size and Growth Projections

The global Bepotastine Besilate market has been experiencing robust growth, driven by increasing demand for effective treatments for allergic conjunctivitis. As of 2023, the market size was significant, and it is projected to continue growing at a substantial compound annual growth rate (CAGR) from 2024 to 2031[4].

Segmentation of the Market

The Bepotastine Besilate market is segmented based on several key factors:

Type

• The market is categorized into segments based on the minimum purity of the product: less than 98%, 98%-99%, and more than 99%. The segment with a minimum purity of less than 98% accounted for a noticeable share of the global market in 2023 and is expected to experience significant growth in the near future[1][4].

Application

• The primary applications are in research and medical fields. The research segment is anticipated to expand at a significant CAGR, retaining its position throughout the forecast period[1][4].

Geography

• The market is analyzed across various geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its unique market dynamics, influenced by factors such as raw material availability, regulatory environments, and consumer behavior[1][4].

Market Drivers

Several factors are driving the growth of the Bepotastine Besilate market:

Increasing Prevalence of Allergic Conjunctivitis

The rising incidence of allergic conjunctivitis, particularly in urban areas due to increased exposure to allergens, is a major driver. This condition necessitates effective treatments, thereby boosting the demand for Bepotastine Besilate[4].

Advancements in Pharmaceutical Technology

Technological advancements in the production of high-quality chemicals and the development of more effective ophthalmic solutions are also driving market growth. Key manufacturers are focusing on improving product quality and expanding their product portfolios[4].

Regulatory Approvals

The FDA approval of Bepotastine Besilate ophthalmic solution in 2009 has been a significant milestone, enhancing market confidence and adoption rates. Similar approvals in other regions are expected to further boost the market[2][5].

Market Restraints

Despite the positive growth trajectory, there are several restraints to consider:

Competitive Landscape

The presence of other approved drugs for similar indications in the U.S. and other regions poses a competitive challenge. However, Bepotastine Besilate's unique mechanism of action and non-sedating properties help it maintain a competitive edge[2][4].

Regulatory Challenges

Navigating through stringent regulatory environments, especially in regions with strict drug approval processes, can be a barrier to market expansion. Companies must comply with various regulatory requirements, which can be time-consuming and costly[4].

Market Opportunities

The Bepotastine Besilate market presents several opportunities for growth:

Emerging Markets

Regions such as Asia-Pacific and South America offer significant growth opportunities due to their large populations and increasing healthcare expenditures. These markets are less saturated compared to North America and Europe, providing room for expansion[1][4].

Research and Development

Continued research and development in the field of ophthalmic solutions can lead to new applications and improved formulations of Bepotastine Besilate. This could expand the market beyond its current scope[4].

Financial Performance and Projections

The financial performance of the Bepotastine Besilate market is robust, with significant revenue growth anticipated:

Revenue Projections

The market is expected to grow substantially from 2024 to 2031, with revenue measured in USD million. The base year for calculations is 2023, and the forecast period extends to 2031[1][4].

Key Players and Their Strategies

Companies such as Merck, Cayman Chemical, and others are focusing on strategy building to strengthen their product portfolios and expand their business in the global market. These strategies include technological advancements, market expansion, and competitive pricing[1][4].

Regional Analysis

The market dynamics vary significantly across different regions:

North America

North America is a mature market with a high demand for ophthalmic solutions. The region is characterized by stringent regulatory environments and a competitive landscape. Despite these challenges, the market is expected to grow due to the increasing prevalence of allergic conjunctivitis[4].

Europe

Europe also presents a significant market for Bepotastine Besilate, driven by advanced healthcare systems and a high standard of living. The region is expected to see steady growth, influenced by regulatory approvals and consumer behavior[4].

Asia-Pacific

The Asia-Pacific region is one of the fastest-growing markets due to its large population and increasing healthcare expenditure. This region offers substantial opportunities for market expansion and is expected to contribute significantly to the global growth of Bepotastine Besilate[1][4].

Technological and Regulatory Trends

The market is influenced by various technological and regulatory trends:

Technological Advancements

Advancements in pharmaceutical technology are crucial for the production of high-quality Bepotastine Besilate. These advancements help in improving the efficacy and safety of the product, which in turn drives market growth[4].

Regulatory Environment

The regulatory environment plays a critical role in the approval and adoption of Bepotastine Besilate. Companies must comply with regional and national regulations, which can impact the market dynamics significantly[2][4].

Consumer Behavior and Market Attractiveness

Consumer behavior and market attractiveness are key factors influencing the growth of the Bepotastine Besilate market:

Consumer Preferences

Consumers are increasingly seeking effective and safe treatments for allergic conjunctivitis. Bepotastine Besilate's non-sedating properties and minimal systemic absorption make it an attractive option, driving consumer preference[5].

Market Attractiveness

The market attractiveness is high due to the growing demand for ophthalmic solutions and the potential for expansion into emerging markets. The market's attractiveness is further enhanced by the presence of key players and their strategic initiatives[4].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the Bepotastine Besilate market. While it disrupted supply chains and delayed some clinical trials, it also accelerated the adoption of telemedicine and online healthcare services, which could benefit the market in the long term[4].

Key Takeaways

• The Bepotastine Besilate market is expected to experience robust growth from 2024 to 2031.
• The market is segmented by type, application, and geography, with the research segment and high-purity products showing significant growth potential.
• Key drivers include the increasing prevalence of allergic conjunctivitis, technological advancements, and regulatory approvals.
• Market restraints include competitive challenges and regulatory hurdles.
• Emerging markets and continued R&D offer significant opportunities for growth.
• The financial performance is projected to be strong, with key players focusing on strategic expansions.

FAQs

What is Bepotastine Besilate used for?

Bepotastine Besilate is used to treat itching associated with allergic conjunctivitis. It is a non-sedating, selective antagonist of the histamine 1 (H1) receptor[5].

Who are the key players in the Bepotastine Besilate market?

Key players include Merck, Cayman Chemical, Santa Cruz Biotechnology, and others. These companies are focusing on strategy building to strengthen their product portfolios and expand their business in the global market[1][4].

What are the primary segments of the Bepotastine Besilate market?

The market is segmented by type (minimum purity), application (research and medical), and geography (North America, Europe, Asia-Pacific, South America, and Middle East and Africa)[1][4].

How does Bepotastine Besilate work?

Bepotastine Besilate works by three primary mechanisms: it is a non-sedating, selective antagonist of the histamine 1 (H1) receptor, a mast cell stabilizer, and it suppresses the migration of eosinophils into inflamed tissues[5].

What are the growth projections for the Bepotastine Besilate market?

The market is expected to grow substantially from 2024 to 2031, with a significant compound annual growth rate (CAGR). The revenue is projected to increase, measured in USD million[1][4].

Cited Sources:

1. Market Research Intellect - Bepotastine Besilate Market Size, Scope And Forecast Report[1].
2. FDA - Statistical Review and Evaluation Clinical Studies NDA/Serial Number 22,288[2].
3. Pharmaceuticals.gov.in - An Analysis on leveraging the patent cliff with drug sales worth USD 251 billion[3].
4. Cognitive Market Research - Global Bepotastine Besilate Market Report 2024 Edition[4].
5. DrugBank - Bepotastine: Uses, Interactions, Mechanism of Action[5].