Levalbuterol tartrate - Generic Drug Details

What are the generic sources for levalbuterol tartrate and what is the scope of freedom to operate?

Levalbuterol tartrate is the generic ingredient in one branded drug marketed by Lupin and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Levalbuterol tartrate has thirty-six patent family members in eighteen countries.

Four suppliers are listed for this compound.

Summary for levalbuterol tartrate

International Patents:	36
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for levalbuterol tartrate
What excipients (inactive ingredients) are in levalbuterol tartrate?	levalbuterol tartrate excipients list
DailyMed Link:	levalbuterol tartrate at DailyMed

Recent Clinical Trials for levalbuterol tartrate

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

Sponsor	Phase
Sunovion	Phase 2
Sunovion	Phase 3

See all levalbuterol tartrate clinical trials

Pharmacology for levalbuterol tartrate

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Paragraph IV (Patent) Challenges for LEVALBUTEROL TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XOPENEX HFA	Inhalation Aerosol	levalbuterol tartrate	0.045 mg/actuation	021730	1	2012-02-27

US Patents and Regulatory Information for levalbuterol tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005		RX	Yes	Yes			Y	Y

Expired US Patents for levalbuterol tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005

International Patents for levalbuterol tartrate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1572622	SEL DE LEVALBUTEROL (LEVALBUTEROL SALT)
Denmark	2292584
Portugal	1572622
Israel	168739	METERED DOSE INHALER COMPRISING A CANISTER CONTAINING AN AEROSOL FORMULATION COMPRISING LEVALBUTEROL L-TARTRATE AND USE OF LEVALBUTEROL L-TARTRATE IN THE MANUFACTURE OF SAID METERED DOSE INHALER FOR TREATING BRONCHOSPASM

Levalbuterol tartrate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Levalbuterol Tartrate

Market Overview

Levalbuterol tartrate, the (R)-enantiomer of albuterol, is a relatively selective beta2-adrenergic receptor agonist used primarily for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Historical Market Size and Growth

The global market size of levalbuterol tartrate was significant in 2017, with a notable Compound Annual Growth Rate (CAGR) from 2013 to 2017. The market was expected to continue growing, reaching a projected value by the end of 2023 with a CAGR from 2018 to 2023[1].

Geographic Segmentation

The market for levalbuterol tartrate is segmented geographically into several key regions:

North America

This region has been a significant market for levalbuterol tartrate, driven by high healthcare spending and a large patient population with respiratory conditions.

South America

The South American market has shown steady growth, with key countries such as Brazil and Argentina contributing to the demand for levalbuterol tartrate[1].

Asia & Pacific

This region has seen rapid growth due to increasing healthcare infrastructure and a rising prevalence of respiratory diseases. Countries like China, India, and Japan are major contributors to the demand in this region[1].

Europe

Europe is another crucial market, with a well-established healthcare system and a high incidence of respiratory conditions. The demand in Europe is driven by countries such as Germany, the UK, and France[1].

Middle East and Africa (MEA)

The MEA region, though smaller, is growing due to improving healthcare facilities and increasing awareness about respiratory diseases[1].

End Use/Application Segment

The demand for levalbuterol tartrate is primarily driven by its application in treating bronchospasm in patients with reversible obstructive airway disease. This includes:

Treatment of Bronchospasm

Levalbuterol tartrate is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older[2].

Preventive Use

It is also used preventively to manage symptoms of asthma and other respiratory conditions.

Competitor Segment

The market for levalbuterol tartrate includes several key players:

Major Players

Companies like Sepracor (now part of Sunovion Pharmaceuticals) and other pharmaceutical giants are major players in the market. These companies are analyzed based on their company profile, main business information, SWOT analysis, sales, revenue, price, and gross margin, as well as market share[1].

Small Players

In addition to major players, there are smaller companies that also contribute to the market, often through generic or branded formulations.

Pricing and Demand

Pricing Trends

The pricing of levalbuterol tartrate varies by region and is influenced by factors such as regulatory policies, competition, and local healthcare reimbursement systems. The report provides detailed pricing data from 2013 to 2023 for different regions[1].

Demand by Type

The demand for levalbuterol tartrate is segmented by type, including different formulations such as inhalation aerosols and other delivery methods. The demand by type varies across regions based on patient preferences and healthcare provider recommendations[1].

Financial Performance

Revenue and Sales

The revenue and sales of levalbuterol tartrate have shown a steady increase over the years, driven by growing demand and expanding market reach. The financial performance of key players is a critical indicator of the market's overall health[1].

Market Share

Major players in the market have significant market share, with smaller players also vying for a portion of the market. The market share dynamics are influenced by factors such as product efficacy, pricing, and marketing strategies[1].

Regulatory Environment

FDA Approvals

Levalbuterol tartrate, under the brand name XOPENEX HFA, has been approved by the FDA for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older. Regulatory approvals play a crucial role in shaping the market dynamics[2][4].

Patent Landscape

The patent landscape for levalbuterol tartrate is important, as patents nearing expiration can lead to generic competition, affecting the financial trajectory of branded products. Leveraging the patent cliff can be a strategic move for pharmaceutical companies[3].

Clinical Efficacy and Safety

Mechanism of Action

Levalbuterol tartrate works by activating beta2-adrenergic receptors on airway smooth muscle, leading to bronchodilation. Its clinical efficacy is well-documented, with studies showing significant improvement in FEV1 (Forced Expiratory Volume in one second) compared to placebo[2].

Safety Profile

The safety profile of levalbuterol tartrate includes potential cardiovascular effects and other side effects. Clinical trials have monitored these effects closely, ensuring the drug's safety for use in various patient populations[2][4].

Future Outlook

Market Growth Projections

The market for levalbuterol tartrate is expected to continue growing, driven by increasing prevalence of respiratory diseases, expanding healthcare infrastructure, and ongoing research into new formulations and delivery methods.

Competitive Landscape

The competitive landscape is likely to evolve with new entrants and the introduction of generic versions as patents expire. This could lead to price competition and changes in market share dynamics.

Key Takeaways

• Geographic Segmentation: The market is segmented into North America, South America, Asia & Pacific, Europe, and MEA, each with unique demand and supply dynamics.
• End Use: Primarily used for treating bronchospasm in patients with reversible obstructive airway disease.
• Competitor Segment: Major players like Sepracor and smaller companies contribute to the market.
• Pricing and Demand: Pricing varies by region, and demand is segmented by type.
• Financial Performance: Revenue and sales have shown steady growth, with significant market share held by major players.
• Regulatory Environment: FDA approvals and patent landscape are crucial for market dynamics.
• Clinical Efficacy and Safety: The drug has a well-documented mechanism of action and safety profile.

FAQs

What is levalbuterol tartrate used for?

Levalbuterol tartrate is used for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.

How does levalbuterol tartrate work?

It works by activating beta2-adrenergic receptors on airway smooth muscle, leading to bronchodilation.

What are the key regions for the levalbuterol tartrate market?

The key regions include North America, South America, Asia & Pacific, Europe, and the Middle East and Africa.

Who are the major players in the levalbuterol tartrate market?

Major players include companies like Sepracor (now part of Sunovion Pharmaceuticals) and other pharmaceutical giants.

What is the expected future outlook for the levalbuterol tartrate market?

The market is expected to continue growing, driven by increasing prevalence of respiratory diseases and expanding healthcare infrastructure.

Sources

1. 2018 Global Levalbuterol Tartrate Industry Report - Market Publishers
2. XOPENEX HFA™ (levalbuterol tartrate) Inhalation Aerosol - FDA
3. An Analysis on leveraging the patent cliff with drug sales worth USD - Pharmaceuticals.gov.in
4. N21-730S036 Levalbuterol Statistical BPCA - FDA