BETAXON Drug Patent Profile

Which patents cover Betaxon, and what generic alternatives are available?

Betaxon is a drug marketed by Alcon Pharms Ltd and is included in one NDA.

The generic ingredient in BETAXON is levobetaxolol hydrochloride. There is one drug master file entry for this compound. Additional details are available on the levobetaxolol hydrochloride profile page.

Summary for BETAXON

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	1
Patent Applications:	1,019
DailyMed Link:	BETAXON at DailyMed

Recent Clinical Trials for BETAXON

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

Sponsor	Phase
Alcon Research	Phase 3

See all BETAXON clinical trials

US Patents and Regulatory Information for BETAXON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Pharms Ltd	BETAXON	levobetaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	021114-001	Feb 23, 2000		DISCN	No	No

Expired US Patents for BETAXON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Pharms Ltd	BETAXON	levobetaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	021114-001	Feb 23, 2000	4,911,920*PED
Alcon Pharms Ltd	BETAXON	levobetaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	021114-001	Feb 23, 2000	5,540,918*PED

International Patents for BETAXON

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	135695	Sustained-release compositions containing cation exchange resins and polycarboxylic polymers
Finland	962976
Australia	688854

BETAXON Market Analysis and Financial Projection Experimental

Betaxolol Market Dynamics and Financial Trajectory

Introduction to Betaxolol

Betaxolol is a beta-adrenergic receptor inhibitor, primarily used to treat patients with chronic open-angle glaucoma or ocular hypertension. It was first approved by the U.S. Food and Drug Administration (FDA) in 1989 and is available in various forms, including oral tablets and topical eye drops[1].

Market Drivers

Increasing Prevalence of Glaucoma and Hypertension

The global betaxolol market is driven by the increasing prevalence of glaucoma and hypertension. Glaucoma is the leading cause of irreversible blindness worldwide, affecting approximately 64.3 million people globally as of 2013. The condition is more prevalent in Africa and Latin America, creating a significant demand for effective treatments like betaxolol[1].

Growing Diabetic Population

Patients with diabetic retinopathy are more prone to glaucoma due to abnormal blood vessel growth, which can lead to retinopathy and blockage of the eye's natural drainage. The increasing diabetic population is expected to augment the growth of the betaxolol market[1].

Need for Novel Treatment Options

Despite available treatments, some patients do not experience complete relief from glaucoma even after surgery. The need for novel treatment options to reduce intraocular pressure is a key driver for the betaxolol market, offering lucrative opportunities for growth[1].

Market Restraints

Stringent Regulatory Approvals

The betaxolol market faces significant challenges due to stringent regulatory approvals. Ensuring the safety of drugs is a critical factor, and the process can be lengthy and costly. This regulatory environment can hinder the market growth[1].

Patent Expiry and Generic Competition

The patent expiry of branded betaxolol drugs, such as Betoptic S and Betoptic Liq, has led to the entry of generic versions. These generics are sold at 70% to 80% lower prices than the branded drugs, significantly impacting the market dynamics and revenue of branded drug manufacturers[1].

Regional Analysis

North America

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

Asia Pacific

The Asia Pacific region is expected to witness significant growth, driven by the presence of generic key players such as Lupin Ltd. and Cipla Ltd. in India. These companies are engaged in manufacturing generics of betaxolol, which helps them retain market share in the region[1].

Competitive Landscape

The betaxolol market is characterized by strategic moves by market players, including mergers, collaborations, acquisitions, and research and development. For instance, Humanwell Healthcare Group and PuraCap Pharmaceutical acquired Epic Pharma LLC in 2016 to expand their commercial and manufacturing capabilities[1].

Key players in the betaxolol market include Novartis AG, Genix Pharma (Pvt.) Ltd., East West Pharma, Hetero Healthcare Ltd. (GenX), Cadila Pharmaceuticals Ltd., and others. These companies are focused on expanding their business through various organic and inorganic strategies[1].

Financial Trajectory

Revenue Impact of Generic Competition

The entry of generic versions of betaxolol has significantly impacted the revenue of branded drug manufacturers. Generic drugs are sold at much lower prices, leading to a substantial reduction in the market share and revenue of branded drugs[1].

Investment in Research and Development

Companies operating in the betaxolol market are investing heavily in research and development to expand their product portfolios and stay competitive. This includes developing new formulations and improving existing treatments to better address the needs of patients with glaucoma and hypertension[1].

Geographical Expansion

The financial trajectory of the betaxolol market is also influenced by geographical expansion. Companies are focusing on emerging markets, particularly in Asia Pacific, where there is a growing demand for ophthalmic drugs. This expansion helps in diversifying revenue streams and mitigating risks associated with market saturation in developed regions[1].

Market Segmentation

By Dosage Form

The betaxolol market is segmented by dosage form, including oral tablets and topical eye drops. Each form has its specific applications and patient preferences, influencing market dynamics and financial performance[1].

By Disease Indication

The market is also segmented by disease indication, primarily focusing on glaucoma and ocular hypertension. The increasing prevalence of these conditions drives the demand for betaxolol, impacting the financial trajectory of the market[1].

By Distribution Channel

The distribution channel plays a crucial role in the betaxolol market, with sales occurring through various channels such as pharmacies, hospitals, and online platforms. Effective distribution strategies can significantly influence the market's financial performance[1].

Key Takeaways

• The betaxolol market is driven by the increasing prevalence of glaucoma and hypertension.
• Generic competition and stringent regulatory approvals are significant market restraints.
• North America and Asia Pacific are key regions driving market growth.
• Strategic investments in research and development and geographical expansion are crucial for market players.
• Effective distribution channels are essential for market success.

FAQs

1. What is betaxolol used for? Betaxolol is used to treat patients with chronic open-angle glaucoma or ocular hypertension. It can be administered either alone or in combination with other medicines to lower intraocular pressure and blood pressure[1].

2. How does betaxolol work? Betaxolol works by selectively binding and blocking beta-1 adrenergic receptors in the heart, reducing cardiac output and blood pressure. In the eye, it reduces aqueous humor secretion, thereby lowering intraocular pressure[1].

3. What are the common side effects of betaxolol? Common side effects of betaxolol include lightheadedness, drowsiness, dizziness, and headache, particularly during the initial stages of treatment[1].

4. How does generic competition affect the betaxolol market? Generic competition significantly impacts the betaxolol market by reducing the market share and revenue of branded drugs. Generic versions are sold at much lower prices, typically 70% to 80% lower than branded drugs[1].

5. Which regions are expected to drive the growth of the betaxolol market? North America and Asia Pacific are expected to drive the growth of the betaxolol market. North America has a high prevalence of diabetes and eye-related disorders, while Asia Pacific is driven by the presence of generic key players[1].

Cited Sources

1. Coherent Market Insights: Betaxolol Market Size, Trends And Forecast To 2028
2. HKEXnews: Zhaoke Ophthalmology Limited 兆科眼科有限公司
3. HKEXnews: BUSINESS - HKEXnews
4. GlobeNewswire: Insights on the Ophthalmic Drugs Global Market to 2029