LEVALBUTEROL HYDROCHLORIDE - Generic Drug Details

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

Levalbuterol hydrochloride is the generic ingredient in two branded drugs marketed by Cipla, Impax Labs Inc, Luoxin Aurovitas, Mankind Pharma, Mylan Speciality Lp, Norvium Bioscience, Ritedose Corp, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Hikma, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for levalbuterol hydrochloride. Eleven suppliers are listed for this compound.

Summary for LEVALBUTEROL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	12
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	33
Patent Applications:	1,504
What excipients (inactive ingredients) are in LEVALBUTEROL HYDROCHLORIDE?	LEVALBUTEROL HYDROCHLORIDE excipients list
DailyMed Link:	LEVALBUTEROL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for LEVALBUTEROL HYDROCHLORIDE

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

Sponsor	Phase
University of Aleppo	Phase 4
Children's Hospital Los Angeles	N/A
University of Illinois at Chicago	N/A

See all LEVALBUTEROL HYDROCHLORIDE clinical trials

Pharmacology for LEVALBUTEROL HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for LEVALBUTEROL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XOPENEX	Inhalation Solution	levalbuterol hydrochloride	0.25%	020837	1	2006-05-23
XOPENEX	Inhalation Solution	levalbuterol hydrochloride	0.0103%, 0.021% and 0.042%	020837	1	2005-06-20

US Patents and Regulatory Information for LEVALBUTEROL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	077800-001	Mar 15, 2013		DISCN	No	No
Mylan Speciality Lp	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	078309-001	Mar 20, 2009	AN	RX	No	Yes
Impax Labs Inc	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	077756-003	Apr 9, 2008	AN	RX	No	No
Sun Pharm	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	207820-001	Nov 5, 2018		DISCN	No	No
Mankind Pharma	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	218770-003	Oct 21, 2024	AN	RX	No	No
Teva Pharms Usa	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	090297-002	Apr 26, 2013	AN	RX	No	Yes
Ritedose Corp	LEVALBUTEROL HYDROCHLORIDE	levalbuterol hydrochloride	SOLUTION;INHALATION	203653-001	Mar 22, 2016	AN	RX	No	No

Expired US Patents for LEVALBUTEROL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002

LEVALBUTEROL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Levalbuterol Hydrochloride

Introduction

Levalbuterol hydrochloride, a key medication in the treatment of bronchospasm associated with asthma and other lung diseases, has been experiencing significant growth in recent years. This article delves into the market dynamics, financial trajectory, and various factors influencing the levalbuterol hydrochloride market.

Market Growth and Projections

The levalbuterol market has shown a swift and substantial surge in recent years, with projections indicating continued significant expansion from 2023 to 2031. This growth is driven by increasing demand for effective bronchodilators, particularly in the treatment of asthma and chronic obstructive pulmonary disease (COPD)[1].

Market Segmentation

The levalbuterol market is segmented based on type, application, and geography.

Type

The market is categorized into Salbutamol Sulfate and Levalbuterol Hydrochloride. Levalbuterol Hydrochloride, being the R-isomer of albuterol, is gaining traction due to its efficacy and cost-effectiveness[1].

Application

Levalbuterol is used in various forms, including inhalers, nebulizers, tablets, injectants, and others. The inhalation solution and nebulizer forms are particularly popular for treating bronchospasm in patients with asthma and COPD[5].

Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region, especially China, has seen significant growth due to the increasing prevalence of COPD and the introduction of levalbuterol into the Chinese market[1][4].

Drivers of Market Growth

Several factors are driving the growth of the levalbuterol hydrochloride market:

Increasing Prevalence of Respiratory Diseases

The rising incidence of asthma and COPD globally is a major driver. These diseases require effective bronchodilators, making levalbuterol a preferred treatment option[5].

Cost-Effectiveness

Studies have shown that levalbuterol is a cost-saving option compared to albuterol, particularly in hospitalized patients with COPD. This cost-effectiveness is a significant driver, especially in healthcare systems looking to manage budgets efficiently[4].

Regulatory Approvals and Generic Versions

The launch of generic versions of levalbuterol, such as the authorized generic version of Xopenex® by Watson Pharmaceuticals, has expanded market access and reduced costs for patients. Regulatory approvals and agreements with pharmaceutical companies further support market growth[3].

Market Dynamics: Opportunities and Challenges

Opportunities

• Emerging Markets: The Asia-Pacific region, particularly China, offers significant growth opportunities due to the increasing demand for respiratory medications.
• Generic Market: The availability of generic versions of levalbuterol opens up new market segments and increases competition, driving down prices and increasing accessibility[1][3].

Challenges

• Regulatory Hurdles: Obtaining FDA and other regulatory approvals can be challenging and time-consuming, affecting the launch and distribution of new products.
• Competitive Landscape: The market is highly competitive, with several established and emerging players. This competition can lead to pricing pressures and market share challenges[1][3].

Financial Trajectory

Revenue Projections

The levalbuterol market is expected to generate significant revenue, with projections indicating substantial growth from 2023 to 2031. The market size is measured in USD million, reflecting the robust growth rates anticipated during the forecast period[1].

Cost-Utility Analysis

A cost-utility analysis in China revealed that levalbuterol saved ¥495.7 ($105.1) per hospitalization compared to albuterol. Additionally, the budget impact analysis showed a potential saving of ¥22.3 ($6.8) million over three years, highlighting the financial benefits of using levalbuterol[4].

Market Value

For the most recent twelve months ending June 30, 2012, Xopenex® (levalbuterol HCl) had total U.S. sales of approximately $474 million, according to IMS Health data. This figure indicates the significant market value of levalbuterol products[3].

Competitive Landscape

The competitive landscape of the levalbuterol market includes key players such as Mylan, Cambrex, Neuraxpharm, Teva Pharmaceutical Industries, Hovione, Prajna Generics, and Supriya Lifescience. These companies are profiled based on their market entry year, product offerings, and regional presence[1].

Emerging Trends and Innovations

• Generic and Biosimilar Products: The introduction of generic and biosimilar versions of levalbuterol is expected to continue, increasing market competition and reducing costs.
• Advanced Delivery Systems: Innovations in inhalation devices and nebulizers are enhancing the efficacy and convenience of levalbuterol administration[3][5].

Key Players and Their Strategies

Key players in the levalbuterol market are focusing on strategic collaborations, mergers and acquisitions, and the development of new products. For example, Watson Pharmaceuticals launched an authorized generic version of Xopenex®, expanding market access and reducing costs for patients[3].

Regional and Industry Footprint

Companies are expanding their regional and industry footprint through strategic moves. For instance, the entry of levalbuterol into the Chinese market has been a significant development, driven by cost-utility and budget impact analyses that favor levalbuterol over albuterol[1][4].

Conclusion

The levalbuterol hydrochloride market is poised for significant growth driven by increasing demand for effective bronchodilators, cost-effectiveness, and the availability of generic versions. Despite challenges such as regulatory hurdles and competitive pressures, the market's financial trajectory indicates robust growth rates and substantial revenue projections.

Key Takeaways

• The levalbuterol market is expected to grow significantly from 2023 to 2031.
• The market is driven by the increasing prevalence of respiratory diseases and the cost-effectiveness of levalbuterol.
• Generic versions and emerging markets, especially in Asia-Pacific, are key growth drivers.
• The competitive landscape includes major pharmaceutical companies focusing on strategic collaborations and product innovations.
• Cost-utility and budget impact analyses highlight the financial benefits of using levalbuterol.

FAQs

1. What is levalbuterol hydrochloride used for? Levalbuterol hydrochloride is used to prevent or treat bronchospasm in patients with asthma and other lung diseases[5].

2. What are the different forms of levalbuterol? Levalbuterol is available in various forms, including inhalers, nebulizers, tablets, and injectants[5].

3. How does levalbuterol compare to albuterol in terms of cost? Levalbuterol has been shown to be a cost-saving option compared to albuterol, particularly in hospitalized patients with COPD[4].

4. Which regions are driving the growth of the levalbuterol market? The Asia-Pacific region, especially China, is a significant driver of market growth due to the increasing prevalence of COPD and the introduction of levalbuterol into the Chinese market[1][4].

5. Who are the key players in the levalbuterol market? Key players include Mylan, Cambrex, Neuraxpharm, Teva Pharmaceutical Industries, Hovione, Prajna Generics, and Supriya Lifescience[1].

Sources

1. Market Research Intellect - Global Levalbuterol Market Size, Scope And Forecast Report
2. Memorial Hospital - CHI Memorial Hospital Georgia - CDM-01-2024.xlsx
3. Fierce Pharma - Watson Launches Generic Xopenex®
4. PubMed - Levalbuterol vs. albuterol for hospitalized patients with COPD in China
5. Mayo Clinic - Levalbuterol (inhalation route) - Mayo Clinic