BETOPTIC Drug Patent Profile

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

Betoptic is a drug marketed by Sandoz, Alcon, and Novartis. and is included in three NDAs.

The generic ingredient in BETOPTIC is betaxolol hydrochloride; pilocarpine hydrochloride. There are eleven drug master file entries for this compound. Additional details are available on the betaxolol hydrochloride; pilocarpine hydrochloride profile page.

Summary for BETOPTIC

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	210
Clinical Trials:	1
Patent Applications:	4,206
Drug Prices:	Drug price information for BETOPTIC
DailyMed Link:	BETOPTIC at DailyMed

See drug prices for BETOPTIC

Recent Clinical Trials for BETOPTIC

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

Sponsor	Phase
Alcon Research	Phase 3

See all BETOPTIC clinical trials

US Patents and Regulatory Information for BETOPTIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	AT	RX	Yes	Yes
Alcon	BETOPTIC PILO	betaxolol hydrochloride; pilocarpine hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	020619-001	Apr 17, 1997		DISCN	No	No
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845-001	Dec 29, 1989		RX	Yes	Yes

Expired US Patents for BETOPTIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985

International Patents for BETOPTIC

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

Country	Patent Number	Title	Estimated Expiration
Belgium	847801
France	2330383
Norway	142034

BETOPTIC Market Analysis and Financial Projection Experimental

Betoptic (Betaxolol): Market Dynamics and Financial Trajectory

Introduction

Betoptic, also known as betaxolol, is a beta-adrenergic receptor blocker used primarily in the treatment of glaucoma and other ocular hypertension conditions. This article delves into the market dynamics and financial trajectory of Betoptic, highlighting key factors influencing its market performance.

Market Drivers

Increasing Prevalence of Glaucoma

The global prevalence of glaucoma is a significant driver for the Betoptic market. According to the Glaucoma Research Foundation, glaucoma is the leading cause of irreversible blindness worldwide, affecting approximately 64.3 million people globally as of 2013[1].

Diabetic Retinopathy and Hypertension

Patients with diabetic retinopathy are more prone to glaucoma due to abnormal blood vessel growth, which can block the natural drainage of the eye. Additionally, the increasing prevalence of hypertension, particularly pulmonary arterial hypertension, contributes to the demand for betaxolol[1].

Market Restraints

Stringent Regulatory Approvals

The stringent regulatory approvals required to ensure the safety of drugs pose a significant challenge to the growth of the Betoptic market. These regulations can delay market entry and impact the overall profitability of the drug[1].

Patent Expiry and Generic Competition

The patent expiry of branded betaxolol drugs, such as Betoptic S and Betoptic Liq, has led to the introduction of generic versions. These generic drugs are sold at significantly lower prices (70-80% lower) compared to the branded versions, which can erode market share and revenue for original manufacturers[1].

Regional Analysis

North America

North America holds a significant share of the ocular surgery market, driven by the high prevalence of diabetes and eye-related disorders in the region. The U.S. alone has over 1.3 million legally blind individuals, with an estimated 75,000 people expected to suffer from blindness or visual impairment annually[1].

Asia Pacific

The Asia Pacific region is expected to witness substantial growth due to the presence of generic key players such as Lupin Ltd. and Cipla Ltd., especially in India. These companies are engaged in manufacturing generic versions of betaxolol to retain market share in the region[1].

Competitive Landscape

Market Players

The Betoptic market is competitive, with key players including Novartis AG, Genix Pharma (Pvt.) Ltd., East West Pharma, Hetero Healthcare Ltd., and others. These companies employ various strategies such as mergers, collaborations, acquisitions, and research and development to expand their business across different regions[1].

Strategic Moves

For instance, the acquisition of Epic Pharma LLC by Humanwell Healthcare Group and PuraCap Pharmaceutical in 2016 for $550 million was a significant move to expand their commercial and manufacturing capabilities, as well as their presence in the U.S. and international generics market[1].

Financial Performance

Historical Data

Historical financial data from companies like Alcon, Inc. (now part of Novartis) shows significant growth in the ophthalmology sector. For example, Alcon reported a 10.9% increase in global sales in constant currency during the first quarter of 2002, with adjusted net income rising by 14.5%[2].

Current Market Size and Growth

The global ophthalmology drugs market, which includes betaxolol, reached a value of nearly $50,563.47 million in 2021 and is expected to grow to $77,524.68 million by 2026 at a CAGR of 8.92%. This growth is driven by factors such as an aging population, increased healthcare expenditure, and the rise in allergy diseases[4].

Distribution Channels and Sales

Retail Pharmacies and Drug Stores

The retail pharmacies and drug stores segment is expected to gain significant traction, with projected global annual sales of $12,002.1 million by 2026. This indicates a strong distribution network for ophthalmic drugs like betaxolol[4].

Prescription-Based Drugs

Prescription-based drugs, including betaxolol, are expected to gain $15,620.2 million in global annual sales by 2026, highlighting the importance of prescription channels in the ophthalmology drugs market[4].

Generic Drugs Market

Impact of Generic Versions

The generic drugs market is expected to grow substantially, with projected global annual sales of $14,873.5 million by 2026. This growth is driven by the patent expiry of branded drugs and the increasing acceptance of generic alternatives, which affects the financial trajectory of branded betaxolol drugs[4].

Key Takeaways

• The increasing prevalence of glaucoma and related conditions drives the demand for betaxolol.
• Stringent regulatory approvals and patent expiry of branded drugs are significant market restraints.
• North America and Asia Pacific are key regions for the betaxolol market due to high prevalence rates and generic competition.
• The competitive landscape is marked by strategic acquisitions and expansions by key market players.
• The ophthalmology drugs market, including betaxolol, is expected to grow significantly driven by an aging population and increased healthcare expenditure.

FAQs

What is the primary use of Betoptic (betaxolol)?

Betoptic (betaxolol) is primarily used in the treatment of glaucoma and other ocular hypertension conditions.

How does the prevalence of glaucoma impact the Betoptic market?

The increasing prevalence of glaucoma worldwide is a significant driver for the Betoptic market, as it increases the demand for treatments like betaxolol.

What are the major restraints on the Betoptic market?

The major restraints include stringent regulatory approvals and the patent expiry of branded drugs, leading to generic competition.

Which regions are expected to witness significant growth in the Betoptic market?

North America and the Asia Pacific region are expected to witness significant growth due to high prevalence rates and the presence of generic key players.

How does the generic drugs market affect the financial trajectory of Betoptic?

The generic drugs market, driven by patent expiry and lower prices, erodes the market share and revenue of branded betaxolol drugs, impacting their financial trajectory.

Sources

1. Coherent Market Insights: Betaxolol Market Size, Trends And Forecast To 2028.
2. Alcon, Inc.: Alcon Reports 17.9 Percent Increase In First Quarter Earnings Per Share.
3. Review of Optometry: 2016 Clinical Guide to Ophthalmic Drugs.
4. The Business Research Company: Global Ophthalmology Drugs Market Report And Strategies To 2032.
5. HKEXnews: Ocumension Therapeutics 歐康維視生物.