BETAGAN Drug Patent Profile

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

Betagan is a drug marketed by Allergan and is included in two NDAs.

The generic ingredient in BETAGAN is levobunolol hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the levobunolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Betagan

A generic version of BETAGAN was approved as levobunolol hydrochloride by BAUSCH AND LOMB on March 4^th, 1994.

Summary for BETAGAN

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	39
Patent Applications:	957
Drug Prices:	Drug price information for BETAGAN
What excipients (inactive ingredients) are in BETAGAN?	BETAGAN excipients list
DailyMed Link:	BETAGAN at DailyMed

See drug prices for BETAGAN

US Patents and Regulatory Information for BETAGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	BETAGAN	levobunolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019814-001	Jun 28, 1989		DISCN	Yes	No
Allergan	BETAGAN	levobunolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019219-002	Dec 19, 1985	AT	RX	Yes	Yes

Expired US Patents for BETAGAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	BETAGAN	levobunolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019219-002	Dec 19, 1985	3,641,152

International Patents for BETAGAN

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

Country	Patent Number	Title	Estimated Expiration
Belgium	739195
Italy	1033032	3,4 DIIDRONAFTALENONOSSI.2. IDROSSI. PROPILAMMINE
Netherlands	6914077
Denmark	129649

BETAGAN Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for BETAGAN

Introduction

BETAGAN, also known as levobunolol hydrochloride ophthalmic solution, is a noncardioselective beta-adrenoceptor blocking agent used primarily to lower intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension. Here, we will delve into the market dynamics and financial trajectory of BETAGAN.

Market Overview

BETAGAN is part of the ophthalmic pharmaceutical market, which is a niche but significant segment within the broader pharmaceutical industry. The demand for ophthalmic drugs is driven by the increasing prevalence of eye diseases such as glaucoma, cataracts, and age-related macular degeneration.

Competitive Landscape

The ophthalmic pharmaceutical market is competitive, with several players offering various treatments for glaucoma and other eye conditions. BETAGAN, manufactured by Allergan, competes with other beta-blockers and non-beta-blocker treatments. The competitive landscape is influenced by factors such as efficacy, safety profile, and pricing strategies[4].

Regulatory Environment

BETAGAN was approved by the FDA in 1985 for the 0.5% formulation and in 1989 for the 0.25% formulation, although the latter has been discontinued. Regulatory approvals and compliance are crucial for the continued market presence of BETAGAN. Any changes in regulatory requirements or the introduction of new guidelines can impact the drug's market dynamics[4].

Clinical Efficacy and Safety

BETAGAN has been shown to be effective in lowering IOP, with a significant decrease in IOP maintained for up to 24 hours following a single dose. It has a favorable safety profile, with minimal effects on pupil size, tear production, or corneal sensitivity. However, it is contraindicated in patients with certain cardiovascular and respiratory conditions[1].

Financial Performance of the Manufacturer

Allergan, the manufacturer of BETAGAN, has undergone significant changes, including mergers and acquisitions. For instance, Allergan was acquired by AbbVie in 2020. The financial performance of the parent company can influence the marketing and distribution strategies for BETAGAN.

Generic Availability

The generic availability of levobunolol hydrochloride ophthalmic solution can impact the market dynamics of BETAGAN. Generic versions can offer cheaper alternatives, potentially reducing the market share of the branded product. However, as of the latest updates, BETAGAN remains a branded product with specific formulations approved by the FDA[4].

Revenue and Market Share

While specific revenue figures for BETAGAN alone are not readily available, the overall performance of Allergan and its successors can provide insights. The ophthalmic segment is a part of a larger pharmaceutical portfolio, and its financial performance is often reported as part of the broader company results.

Geographical Presence

BETAGAN is available in various markets globally, although its penetration and market share can vary by region. The drug's availability is subject to local regulatory approvals and market conditions.

Patient and Prescriber Preferences

Patient and prescriber preferences play a significant role in the market dynamics of BETAGAN. Factors such as ease of use, side effect profile, and efficacy influence prescribing decisions. Additionally, patient compliance with the treatment regimen is crucial for the drug's success.

Challenges and Opportunities

One of the challenges facing BETAGAN is the presence of alternative treatments for glaucoma, including other beta-blockers and non-beta-blocker medications. However, the drug's established track record and clinical efficacy provide opportunities for continued market presence. Innovations in delivery systems or combination therapies could also enhance its market position.

Future Outlook

The future outlook for BETAGAN is influenced by several factors, including the evolution of glaucoma treatment options, changes in regulatory environments, and the introduction of generic versions. Continuous monitoring of clinical outcomes and patient preferences will be essential for maintaining its market share.

Key Takeaways

• Clinical Efficacy: BETAGAN is effective in lowering IOP with a favorable safety profile.
• Regulatory Approval: Approved by the FDA in 1985 and 1989 for different formulations.
• Competitive Landscape: Part of a competitive ophthalmic pharmaceutical market.
• Generic Availability: Currently available as a branded product, with potential generic competition.
• Financial Performance: Influenced by the overall performance of its parent company.
• Geographical Presence: Available globally, subject to local regulatory approvals.

FAQs

1. What is BETAGAN used for? BETAGAN is used to lower intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension[1].

2. Who manufactures BETAGAN? BETAGAN is manufactured by Allergan, which is now part of AbbVie[4].

3. Is BETAGAN available in generic form? As of the latest updates, BETAGAN is available as a branded product, but generic versions of levobunolol hydrochloride ophthalmic solution may be available in the future[4].

4. What are the common side effects of BETAGAN? Common side effects include decreases in heart rate and blood pressure, and less frequently, iridocyclitis, headache, and dizziness[1].

5. How does BETAGAN lower intraocular pressure? The primary mechanism of BETAGAN in reducing IOP is through a decrease in aqueous humor production[1].

Cited Sources:

1. BETAGAN® (levobunolol hydrochloride ophthalmic solution, USP) sterile - FDA Label[1].
2. Generic Betagan Availability - Drugs.com[4].
3. Investor Presentation FY '23 - Beta drugs Ltd. - Beta Drugs Limited[3].