BETOPTIC S Drug Patent Profile

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

Betoptic S is a drug marketed by Novartis and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Betoptic S

A generic version of BETOPTIC S was approved as betaxolol hydrochloride by EPIC PHARMA on October 22^nd, 1999.

Summary for BETOPTIC S

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	1
Patent Applications:	1,767
Drug Prices:	Drug price information for BETOPTIC S
What excipients (inactive ingredients) are in BETOPTIC S?	BETOPTIC S excipients list
DailyMed Link:	BETOPTIC S at DailyMed

See drug prices for BETOPTIC S

Recent Clinical Trials for BETOPTIC S

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

Sponsor	Phase
Alcon Research	Phase 3

See all BETOPTIC S clinical trials

Pharmacology for BETOPTIC S

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

US Patents and Regulatory Information for BETOPTIC S

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

Expired US Patents for BETOPTIC S

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845-001	Dec 29, 1989
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845-001	Dec 29, 1989

International Patents for BETOPTIC S

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0741563
Japan	H0725698
Finland	962976

BETOPTIC S Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Betoptic S (Betaxolol)

Introduction to Betoptic S

Betoptic S, containing the active ingredient betaxolol hydrochloride, is a beta-adrenergic receptor inhibitor used primarily for the treatment of elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Drivers

Increasing Prevalence of Glaucoma

The global betaxolol market is significantly driven by the increasing prevalence of glaucoma. 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, and the rising prevalence of diabetes contributes to the growth of the betaxolol market. Additionally, the increasing prevalence of hypertension diseases, such as pulmonary arterial hypertension, also drives the demand for betaxolol[1].

Market Restraints

Stringent Regulatory Approvals

The market growth is hindered by stringent regulatory approvals required to ensure the safety of drugs. This stringent regulatory environment can delay the entry of new products into the market[1].

Patent Expiry and Generic Competition

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

Discontinuation of Betoptic and Betoptic S

In a recent development, Novartis has announced the global discontinuation of Betoptic and Betoptic S eye drops. This discontinuation is expected to impact the market significantly, with the last supplies anticipated to run out by June 2025 and delisting from the Pharmaceutical Schedule by December 2025[3].

Regional Analysis

North America

North America holds a significant share of the betaxolol market, primarily due to the high prevalence of diabetes and eye-related disorders in the region. The U.S. alone has over 1.3 million people who are legally blind, and this number is expected to increase annually[1].

Asia Pacific

The Asia Pacific region is expected to witness significant 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

The betaxolol market is characterized by organic and inorganic strategies adopted by market players. These include mergers, collaborations, acquisitions, and research and development to expand their business across regions. For instance, Humanwell Healthcare Group and PuraCap Pharmaceutical acquired Epic Pharma LLC in 2016 to enhance their commercial and manufacturing capabilities[1].

Key players in the betaxolol market include Novartis AG, Genix Pharma, East West Pharma, Hetero Healthcare Ltd., and Cadila Pharmaceuticals Ltd.[1].

Financial Impact of Discontinuation

The discontinuation of Betoptic and Betoptic S by Novartis will have a significant financial impact on the market. Patients will need to switch to alternative treatments, such as timolol, which are fully funded ophthalmic beta blockers. This transition may lead to a shift in market share and revenue for other glaucoma treatments[3].

Alternative Treatments and Market Shift

With the discontinuation of Betoptic S, other fully funded ophthalmic beta blockers like timolol are expected to gain market share. This shift will likely influence the financial trajectory of the betaxolol market, as patients and healthcare providers adapt to new treatment options[3].

Pharmacological and Clinical Benefits

Betoptic S has several pharmacological and clinical benefits that have contributed to its market presence. It reduces elevated intraocular pressure with minimal effect on pulmonary and cardiovascular parameters, making it a preferred choice for patients with glaucoma. The drug also has neuroprotective properties and is well-tolerated in patients wearing contact lenses or those who have undergone laser trabeculoplasty[4].

Clinical Trials and Efficacy

Clinical trials have shown that Betoptic S Suspension has a superior long-term benefit on the visual field compared to timolol. It has minimal systemic adverse effects and is effective in reducing intraocular pressure within 30 minutes, with the maximum effect observed at 2 hours after topical administration[4].

Key Takeaways

• The betaxolol market is driven by the increasing prevalence of glaucoma and diabetic retinopathy.
• Stringent regulatory approvals and patent expiry of branded drugs are significant market restraints.
• The discontinuation of Betoptic and Betoptic S by Novartis will lead to a market shift towards alternative treatments like timolol.
• Betoptic S has distinct pharmacological and clinical benefits, including minimal systemic adverse effects and neuroprotective properties.

FAQs

What is the primary use of Betoptic S?

Betoptic S is primarily used for the treatment of elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.

Why is the betaxolol market growing?

The betaxolol market is growing due to the increasing prevalence of glaucoma and diabetic retinopathy, as well as the rising prevalence of hypertension diseases.

What are the major restraints for the betaxolol market?

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

What is the impact of the discontinuation of Betoptic and Betoptic S?

The discontinuation will lead to a shift in market share towards alternative treatments like timolol and may cause temporary disruption for patients and healthcare providers.

What are the pharmacological benefits of Betoptic S?

Betoptic S reduces elevated intraocular pressure with minimal effect on pulmonary and cardiovascular parameters and has neuroprotective properties.

Cited Sources:

1. Coherent Market Insights - Betaxolol Market Size, Trends And Forecast To 2028
2. FDA - Betoptic S® (betaxolol hydrochloride ophthalmic suspension) 0.25%
3. Pharmac.govt.nz - Betoptic and Betoptic S (betaxolol) eyedrops: Discontinuation
4. Novartis - BETOPTIC® S - Novartis