Levobunolol hydrochloride - Generic Drug Details

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

Levobunolol hydrochloride is the generic ingredient in three branded drugs marketed by Epic Pharma Llc, Allergan, Alcon Labs Inc, Apotex Inc, Bausch And Lomb, and Chartwell Rx, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for levobunolol hydrochloride. One supplier is listed for this compound.

Summary for levobunolol hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	10
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	35
Patent Applications:	852
What excipients (inactive ingredients) are in levobunolol hydrochloride?	levobunolol hydrochloride excipients list
DailyMed Link:	levobunolol hydrochloride at DailyMed

Pharmacology for levobunolol hydrochloride

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

Medical Subject Heading (MeSH) Categories for levobunolol hydrochloride

Adrenergic beta-Antagonists

Sympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for levobunolol hydrochloride

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

US Patents and Regulatory Information for levobunolol hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Epic Pharma Llc	AKBETA	levobunolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	074779-001	Oct 29, 1996		DISCN	No	No
Allergan	BETAGAN	levobunolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019219-002	Dec 19, 1985	AT	RX	Yes	Yes
Apotex Inc	LEVOBUNOLOL HYDROCHLORIDE	levobunolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	075475-001	Aug 3, 2000		DISCN	No	No

Expired US Patents for levobunolol hydrochloride

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

Levobunolol hydrochloride Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Levobunolol Hydrochloride

Introduction to Levobunolol Hydrochloride

Levobunolol hydrochloride is a beta-adrenergic antagonist primarily used to reduce elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. It is an ophthalmic beta-blocker effective at both β(1)- and β(2)-receptor sites, making it a crucial medication in ophthalmology[2].

Market Growth and Projections

The Levobunolol Hydrochloride Market has experienced significant growth in recent years and is projected to continue this upward trend from 2023 to 2031. This growth is driven by increasing demand for effective treatments for ocular hypertension and glaucoma, as well as advancements in ophthalmic care.

• Market Size and Segmentation: The market is segmented by type (0.0025% and 0.005%), application (hospital, pharmacy, and other), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The report provides a detailed analysis of market size and predictions in terms of revenue across these segments[1].

Drivers of Market Growth

Several factors are driving the growth of the Levobunolol Hydrochloride Market:

Increasing Prevalence of Glaucoma and Ocular Hypertension

The rising incidence of glaucoma and ocular hypertension, particularly among the aging population, is a significant driver. As the global population ages, the demand for effective treatments like levobunolol hydrochloride is expected to increase.

Efficacy and Safety Profile

Studies have shown that levobunolol is as effective and safe as other commonly used medications like timolol for the long-term control of IOP. This efficacy and safety profile enhances its market appeal[4].

Advancements in Ophthalmic Care

Advancements in ophthalmic care and the development of new formulations and delivery methods are also contributing to market growth.

Market Dynamics

Competitive Landscape

The market is characterized by a mix of established and emerging players. Key companies profiled in the market include AbbVie, Akorn Pharma, Alcon, Apotex, Bausch & Lomb, Indiana Ophthalmics, Pharmascience, Sandoz, and Wuhan Binhu Double Crane Pharmaceutical Co. Ltd. These companies are actively involved in research, development, and marketing strategies to capture a larger market share[1].

Porter's 5 Forces Framework

An analysis using Porter's 5 Forces Framework reveals that the market is influenced by factors such as the bargaining power of suppliers, the bargaining power of buyers, the threat of new entrants, the threat of substitute products, and the intensity of rivalry among competitors. The report provides a comprehensive analysis of these forces to understand their impact on market dynamics[1].

Financial Trajectory

Revenue Projections

The Levobunolol Hydrochloride Market is expected to generate significant revenue over the forecast period from 2023 to 2031. The market size is projected to grow at a robust rate, driven by the increasing demand for the drug and the expanding reach into various geographical regions[1].

Pricing Analysis

The pricing of levobunolol hydrochloride varies based on concentration and volume. For instance, a 0.5% solution can range from $17.26 to $50.25 per bottle, depending on the volume. This pricing structure is influenced by production costs, market competition, and regulatory factors[2].

Regional Market Performance

The market performance varies across different regions. North America and Europe are significant markets due to their well-established healthcare systems and high demand for ophthalmic treatments. The Asia-Pacific region is also expected to show substantial growth due to its large population and increasing healthcare expenditure[1].

Challenges and Opportunities

Challenges

Despite the growth, the market faces several challenges, including the potential for systemic side effects such as bronchoconstriction and cardiovascular effects. Additionally, the market is subject to regulatory scrutiny and competition from other ophthalmic medications[2].

Opportunities

The market presents several opportunities, particularly in emerging markets where there is a growing need for affordable and effective ophthalmic treatments. Innovations in drug delivery systems and the development of generic versions of levobunolol hydrochloride also offer potential growth avenues[1].

Clinical Efficacy and Safety

Clinical Studies

Clinical studies have consistently shown that levobunolol hydrochloride is effective in lowering IOP. For example, a three-month clinical study found that a single daily application of 0.5% levobunolol hydrochloride controlled the IOP of 72% of subjects, achieving an overall mean decrease in IOP of 7.0 mm Hg[5].

Safety Profile

The safety profile of levobunolol hydrochloride is well-documented. It has been shown to be safe for long-term use, with minimal significant ocular side effects. However, it can produce systemic effects such as decreased heart rate and blood pressure[4].

Key Takeaways

• The Levobunolol Hydrochloride Market is experiencing significant growth driven by increasing demand for effective ophthalmic treatments.
• The market is segmented by type, application, and geographical regions, with North America and Europe being key markets.
• The competitive landscape includes both established and emerging players.
• Clinical studies have confirmed the efficacy and safety of levobunolol hydrochloride.
• The market faces challenges such as systemic side effects and regulatory scrutiny but also presents opportunities in emerging markets and innovations in drug delivery.

FAQs

What is levobunolol hydrochloride used for?

Levobunolol hydrochloride is used to reduce elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma[2].

How effective is levobunolol hydrochloride in lowering IOP?

Levobunolol hydrochloride has been shown to reduce mean IOP by approximately 25-40% from baseline and is as effective as other medications like timolol[4][5].

What are the potential side effects of levobunolol hydrochloride?

Potential side effects include systemic pulmonary and cardiovascular effects such as bronchoconstriction, increased airway resistance, decreased heart rate, and blood pressure[2].

Which companies are key players in the levobunolol hydrochloride market?

Key companies include AbbVie, Akorn Pharma, Alcon, Apotex, Bausch & Lomb, Indiana Ophthalmics, Pharmascience, Sandoz, and Wuhan Binhu Double Crane Pharmaceutical Co. Ltd.[1].

What is the projected market growth for levobunolol hydrochloride from 2023 to 2031?

The market is expected to grow at a robust rate, driven by increasing demand and expanding geographical reach, with significant revenue projections over the forecast period[1].

Sources

1. Market Research Intellect: Global Levobunolol Hydrochloride Market Size, Trends and Projections[1].
2. DrugBank: Levobunolol: Uses, Interactions, Mechanism of Action[2].
3. Market Research Intellect: Global Leucine Market Size, Trends and Projections (for comparative market analysis)[3].
4. JAMA Network: Levobunolol Compared With Timolol for the Long-term Control of Elevated Intraocular Pressure[4].
5. DailyMed: Label: LEVOBUNOLOL HYDROCHLORIDE solution/ drops[5].