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XOPENEX HFA Drug Patent Profile

Which patents cover Xopenex Hfa, and when can generic versions of Xopenex Hfa launch?

Xopenex Hfa is a drug marketed by Lupin and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in eighteen countries.

The generic ingredient in XOPENEX HFA is levalbuterol tartrate. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xopenex Hfa

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for XOPENEX HFA

International Patents:	36
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	6
Drug Prices:	Drug price information for XOPENEX HFA
Drug Sales Revenues:	Drug sales revenues for XOPENEX HFA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XOPENEX HFA
What excipients (inactive ingredients) are in XOPENEX HFA?	XOPENEX HFA excipients list
DailyMed Link:	XOPENEX HFA at DailyMed

See drug prices for XOPENEX HFA

See drug sales revenues for XOPENEX HFA

Recent Clinical Trials for XOPENEX HFA

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Genesys Regional Medical Center	Phase 4
Ascension Genesys Hospital	Phase 4

See all XOPENEX HFA clinical trials

Pharmacology for XOPENEX HFA

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

Paragraph IV (Patent) Challenges for XOPENEX HFA

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 XOPENEX HFA

XOPENEX HFA is protected by one US patents.

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 XOPENEX HFA

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
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005

International Patents for XOPENEX HFA

See the table below for patents covering XOPENEX HFA around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2292584
Denmark	1572622
South Korea	101166955
Germany	60336089
Spain	2263051

XOPENEX HFA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XOPENEX HFA

Introduction

XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is a short-acting beta2-adrenergic agonist used for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global bronchodilators market, which includes XOPENEX HFA, was estimated at USD 22.19 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 3.29% from 2023 to 2030, reaching USD 28.75 billion by 2030[3].

Dominant Segment

Beta-adrenergic bronchodilators, the class to which XOPENEX HFA belongs, dominated the market in 2022 with a revenue share of more than 40.0%. This segment is expected to expand at the fastest CAGR of 3.33% during the forecast period[3].

Disease Prevalence and Market Impact

The asthma segment, which is a significant market for XOPENEX HFA, accounted for the largest revenue share of 41.9% in the market in 2022. The increasing prevalence of asthma globally, affecting 262 million patients according to WHO estimates, drives the demand for bronchodilators like XOPENEX HFA[3].

Product Specifics

XOPENEX HFA is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease. It is formulated for use with a metered dose inhaler and has been shown to produce significant improvements in forced expiratory volume in 1 second (FEV1) compared to placebo[5].

Competitive Landscape

The bronchodilators market is highly competitive, with several major products in the short-acting category, including levalbuterol (XOPENEX HFA), albuterol (Proair HFA, Proventil HFA, AccuNeb, Ventolin HFA), and epinephrine injection. The market is driven by the need for effective and convenient treatments for respiratory conditions[3].

Financial Performance of XOPENEX HFA

Historical Ownership and Sales

XOPENEX HFA was developed and launched by Sunovion Pharmaceuticals Inc., a subsidiary of Sumitomo Pharma Co., Ltd. In October 2022, Sumitomo Pharma announced the divestiture of the U.S. market rights to XOPENEX HFA to Lupin Limited for $75 million. This move was part of Sumitomo Pharma's strategy to reallocate resources to medium to long-term growth areas and improve profitability[1].

Revenue Impact

The divestiture of XOPENEX HFA and another product, Brovana, was expected to be recorded as other operating income in the third quarter of the fiscal year ending March 31, 2023. This transaction was already factored into Sumitomo Pharma's financial forecast for that fiscal year[1].

Financial Trajectory of Sumitomo Pharma

Sumitomo Pharma's consolidated financial results for the year ended March 31, 2023, showed a decline in revenue and profitability. The company's revenue decreased by 0.8% year-on-year to 555.5 billion yen, and the core operating profit decreased significantly by 72.0% to 16.4 billion yen. The net profit also decreased substantially to -96.7 billion yen, reflecting various non-recurring items and operational challenges[2].

Impact of Divestiture

The divestiture of XOPENEX HFA to Lupin Limited is part of a broader strategy by Sumitomo Pharma to focus on more profitable and growth-oriented areas. This move allows Sumitomo Pharma to reallocate resources and potentially improve its financial performance in the long term[1].

Future Outlook

Given the growing demand for bronchodilators and the expanding market size, XOPENEX HFA is likely to continue playing a significant role in the treatment of respiratory conditions. Under the new ownership of Lupin Limited, the product may see enhanced distribution and marketing efforts, potentially increasing its market share and revenue.

Key Takeaways

• Market Growth: The global bronchodilators market is expected to grow at a CAGR of 3.29% from 2023 to 2030.
• Dominant Segment: Beta-adrenergic bronchodilators, including XOPENEX HFA, dominate the market.
• Disease Prevalence: Increasing prevalence of asthma drives demand for XOPENEX HFA.
• Financial Performance: The divestiture of XOPENEX HFA to Lupin Limited was part of Sumitomo Pharma's strategy to improve profitability.
• Future Outlook: XOPENEX HFA is likely to continue being a significant player in the bronchodilators market under new ownership.

FAQs

What is XOPENEX HFA used for?

XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol 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[5].

Who is the current owner of XOPENEX HFA?

As of October 2022, the U.S. market rights to XOPENEX HFA were divested to Lupin Limited by Sumitomo Pharma's subsidiary, Sunovion Pharmaceuticals Inc.[1].

What is the expected growth rate of the bronchodilators market?

The global bronchodilators market is expected to grow at a compound annual growth rate (CAGR) of 3.29% from 2023 to 2030[3].

How does XOPENEX HFA compare to other bronchodilators?

XOPENEX HFA has been shown to produce significant improvements in FEV1 compared to placebo and is comparable to other short-acting beta2-adrenergic agonists like albuterol[5].

What was the financial impact of the divestiture of XOPENEX HFA on Sumitomo Pharma?

The divestiture of XOPENEX HFA to Lupin Limited was expected to be recorded as other operating income in the third quarter of the fiscal year ending March 31, 2023, and was part of Sumitomo Pharma's strategy to reallocate resources and improve profitability[1].

Sources

1. Sumitomo Pharma Announces Intent to Divest Brovana and Xopenex HFA to Lupin - Sumitomo Pharma
2. Consolidated Financial Results for the Year Ended March 31, 2023 - Sumitomo Pharma
3. Bronchodilators Market Size & Trends Analysis Report, 2030 - Grand View Research
4. Akorn, Inc. Ponies Up $45 Million Cash For Sunovion Pharmaceuticals Inc.'s Xopenex and Levalbuterol HCl Inhalation Solution - BioSpace
5. XOPENEX HFA™ (levalbuterol tartrate) Inhalation Aerosol - FDA Label[5].