BETAXOLOL HYDROCHLORIDE - Generic Drug Details

What are the generic sources for betaxolol hydrochloride and what is the scope of freedom to operate?

Betaxolol hydrochloride is the generic ingredient in six branded drugs marketed by Acella, Apotex Inc, Medimetriks Pharms, Sciegen Pharms Inc, Sandoz, Novartis, Epic Pharma, Kvk Tech, Sanofi Aventis Us, and Alcon, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for betaxolol hydrochloride. Five suppliers are listed for this compound.

Summary for BETAXOLOL HYDROCHLORIDE

US Patents:	0
Tradenames:	6
Applicants:	10
NDAs:	11
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	5
Patent Applications:	2,554
What excipients (inactive ingredients) are in BETAXOLOL HYDROCHLORIDE?	BETAXOLOL HYDROCHLORIDE excipients list
DailyMed Link:	BETAXOLOL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BETAXOLOL HYDROCHLORIDE

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

Sponsor	Phase
Zagazig University	Phase 2
Weill Medical College of Cornell University	Phase 4
National Institute on Aging (NIA)	Phase 4

See all BETAXOLOL HYDROCHLORIDE clinical trials

Pharmacology for BETAXOLOL HYDROCHLORIDE

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for BETAXOLOL HYDROCHLORIDE

Adrenergic beta-1 Receptor Antagonists

Antihypertensive Agents

Sympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for BETAXOLOL HYDROCHLORIDE

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

S01ED	Beta blocking agents
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for BETAXOLOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845-001	Dec 29, 1989		RX	Yes	Yes
Sanofi Aventis Us	KERLEDEX	betaxolol hydrochloride; chlorthalidone	TABLET;ORAL	019807-001	Oct 30, 1992		DISCN	No	No
Sanofi Aventis Us	KERLEDEX	betaxolol hydrochloride; chlorthalidone	TABLET;ORAL	019807-002	Oct 30, 1992		DISCN	No	No
Apotex Inc	BETAXOLOL HYDROCHLORIDE	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	075446-001	Sep 28, 2000		DISCN	No	No

Expired US Patents for BETAXOLOL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	4,252,984
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845-001	Dec 29, 1989	4,911,920*PED
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845-001	Dec 29, 1989	4,342,783
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	4,311,708

BETAXOLOL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Betaxolol Hydrochloride Market Dynamics and Financial Trajectory

Introduction

Betaxolol hydrochloride, a selective β1-receptor antagonist, is widely used in the treatment of glaucoma and hypertension. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Drivers

The betaxolol hydrochloride market is driven by several key factors:

Increasing Prevalence of Glaucoma

Glaucoma is the leading cause of irreversible blindness worldwide, affecting approximately 64.3 million people globally as of 2013. The high prevalence, especially in Africa and Latin America, and the fact that 10% of glaucoma patients experience vision loss despite treatment, create a significant demand for effective treatments like betaxolol hydrochloride[1][4].

Diabetic Retinopathy and Glaucoma Correlation

Patients with diabetic retinopathy are more prone to glaucoma due to abnormal blood vessel growth that can block the natural drainage of the eye. The increasing diabetic patient pool further augments the market growth for betaxolol hydrochloride[1][4].

Hypertension and Pulmonary Arterial Hypertension

The global prevalence of hypertension and pulmonary arterial hypertension also drives the market. Although treatments for pulmonary arterial hypertension are limited, beta-adrenergic receptor inhibitors like betaxolol hydrochloride play a crucial role in managing symptoms and improving quality of life[1][4].

Market Restraints

Despite the growing demand, the betaxolol hydrochloride market faces several challenges:

Stringent Regulatory Approvals

Ensuring the safety of drugs through stringent regulatory approvals is a significant hurdle. This process can delay market entry and impact the financial trajectory of new and existing products[1].

Patent Expiry and Generic Competition

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

Regional Analysis

The global betaxolol hydrochloride market is segmented into several regions:

North America

North America holds the maximum share, primarily due to 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 new cases of blindness or visual impairment annually[1].

Asia Pacific

The Asia Pacific region is expected to witness significant growth, driven by the presence of generic manufacturers such as Lupin Ltd. and Cipla Ltd. in India. These companies are engaged in producing generic versions of betaxolol hydrochloride to retain market share[1].

Competitive Landscape

The competitive landscape of the betaxolol hydrochloride market is dynamic:

Market Players

Key players include Novartis AG, Genix Pharma (Pvt.) Ltd., East West Pharma, Hetero Healthcare Ltd., Cadila Pharmaceuticals Ltd., and others. These companies employ various strategies such as mergers, collaborations, acquisitions, and research and development to expand their business[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 commercial and manufacturing capabilities in the U.S. and international generics market[1].

Financial Trajectory

The financial trajectory of the betaxolol hydrochloride market is influenced by several factors:

Revenue Growth

The market is expected to grow significantly due to the increasing prevalence of glaucoma and hypertension. The need for novel treatment options, especially for refractory glaucoma patients, drives the demand for betaxolol hydrochloride, creating lucrative opportunities for market growth[1][4].

Impact of Generic Competition

The entry of generic versions has reduced the revenue of branded drugs. However, the overall market size is expected to grow as more patients gain access to affordable treatment options[1].

Dosage Forms and Administration

Betaxolol hydrochloride is available in various dosage forms:

Ophthalmic Solution

The ophthalmic solution is used to reduce elevated intraocular pressure and is effective in more than 94% of the population studied. It has a minimal effect on pulmonary and cardiovascular parameters, making it a safer option compared to other beta-blockers like timolol[2].

Oral Administration

For hypertension, betaxolol hydrochloride is available as 10-mg and 20-mg tablets. The oral form is less commonly used for glaucoma treatment but remains an option for managing hypertension[1].

Clinical Studies and Efficacy

Clinical studies have demonstrated the efficacy of betaxolol hydrochloride in reducing intraocular pressure:

Mechanism of Action

The drug reduces aqueous production, as demonstrated by tonography, and its onset of action is generally noted within 30 minutes, with the maximal effect detected 2 hours after topical administration. A single dose provides a 12-hour reduction in intraocular pressure[2].

Safety and Precautions

While betaxolol hydrochloride is generally safe, caution is advised in patients with severe reactive airway disease, asthma, or a history of cardiac failure. The drug is contraindicated in patients with sinus bradycardia, greater than a first-degree atrioventricular block, cardiogenic shock, or overt cardiac failure[2].

Key Takeaways

• The betaxolol hydrochloride market is driven by the increasing prevalence of glaucoma and hypertension.
• The market faces challenges from stringent regulatory approvals and generic competition.
• North America and Asia Pacific are key regions driving market growth.
• The competitive landscape is marked by strategic moves by market players to expand their presence.
• Betaxolol hydrochloride is effective in reducing intraocular pressure with minimal systemic side effects.

Frequently Asked Questions (FAQs)

Q: What is the primary use of betaxolol hydrochloride? A: Betaxolol hydrochloride is primarily used to treat glaucoma by reducing intraocular pressure and also to manage hypertension.

Q: How does betaxolol hydrochloride compare to other beta-blockers like timolol? A: Betaxolol hydrochloride has a minimal effect on pulmonary and cardiovascular parameters compared to timolol, making it a safer option for patients with respiratory issues[2].

Q: What are the common dosage forms of betaxolol hydrochloride? A: Betaxolol hydrochloride is available as ophthalmic solutions and oral tablets. The ophthalmic solution is used for glaucoma, while the oral form is used for hypertension[1][2].

Q: What are the potential side effects of betaxolol hydrochloride? A: Potential side effects include respiratory reactions, cardiac reactions, insomnia, dizziness, and other central nervous system effects. Caution is advised in patients with a history of cardiac failure or severe reactive airway disease[2].

Q: How does the patent expiry of branded drugs impact the market? A: The patent expiry of branded betaxolol hydrochloride drugs leads to the introduction of generic versions, which are sold at significantly lower prices, impacting the revenue of original manufacturers[1].

Sources:

1. Coherent Market Insights - Betaxolol Market Size, Trends And Forecast To 2028
2. FDA - Betaxolol Hydrochloride Ophthalmic Solution, 0.5% as base
3. Statsndata - Global Betaxolol Hydrochloride Ophthalmic Solution Market
4. Coherent Market Insights - Betaxolol Market Size and Trends - Coherent Market Insights
5. MDPI - Chemo-Enzymatic Synthesis of Enantiopure β-Antagonist (S)-Betaxolol