XOPENEX Drug Patent Profile

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

Xopenex is a drug marketed by Hikma and Lupin and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in XOPENEX 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

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for XOPENEX

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	6
Patent Applications:	5,060
Drug Prices:	Drug price information for XOPENEX
Drug Sales Revenues:	Drug sales revenues for XOPENEX
What excipients (inactive ingredients) are in XOPENEX?	XOPENEX excipients list
DailyMed Link:	XOPENEX at DailyMed

See drug prices for XOPENEX

See drug sales revenues for XOPENEX

Recent Clinical Trials for XOPENEX

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

Sponsor	Phase
Henry Ford Health System	Phase 4
Ascension Genesys Hospital	Phase 4
Fahim Khorfan, MD	Phase 4

See all XOPENEX clinical trials

Paragraph IV (Patent) Challenges for XOPENEX

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 XOPENEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-003	Jan 30, 2002		DISCN	Yes	No
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003		DISCN	Yes	No
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999		DISCN	Yes	No
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999		DISCN	Yes	No
Lupin	XOPENEX HFA	levalbuterol tartrate	AEROSOL, METERED;INHALATION	021730-001	Mar 11, 2005		RX	Yes	Yes	7,256,310		Y	Y

Expired US Patents for XOPENEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003	6,083,993
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-001	Mar 25, 1999	5,760,090
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-002	Mar 25, 1999	5,844,002
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003	5,760,090
Hikma	XOPENEX	levalbuterol hydrochloride	SOLUTION;INHALATION	020837-004	Jul 18, 2003	6,451,289

International Patents for XOPENEX

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

Country	Patent Number	Title	Estimated Expiration
Israel	103321	Compositions and polymer fabrics treated with the same
Canada	2093314	COMPOSITIONS ET TISSUS POLYMERES TRAITES AU MOYEN DE CES COMPOSITIONS (COMPOSITIONS AND POLYMER FABRICS TREATED WITH THE SAME)
Singapore	86293	COMPOSITIONS AND POLYMER FABRICS TREATED WITH THE SAME
Hong Kong	161896	Compositions and polymer fabrics treated with the same
Australia	7174191

XOPENEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XOPENEX

Introduction to XOPENEX

XOPENEX, also known as levalbuterol, is a short-acting beta-2 adrenergic agonist used primarily for the treatment of bronchospasm associated with asthma and chronic obstructive pulmonary disease (COPD). 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, has been experiencing steady growth. As of 2022, the global bronchodilators market size was estimated at USD 22.19 billion 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[1].

Segment Dominance

Beta-adrenergic bronchodilators, the class to which XOPENEX belongs, dominated the market with a share of 41.15% in 2022. This dominance is attributed to their effectiveness in targeting smooth muscle cell receptors for airway dilation[1].

Product Formulations and Sales

XOPENEX is available in two main formulations: XOPENEX Inhalation Solution and XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol. The inhalation solution was divested by Sunovion Pharmaceuticals to Akorn, Inc. in 2014 for $45 million, while Sunovion continues to sell the HFA formulation[4].

Financial Impact of Divestiture

The divestiture of XOPENEX Inhalation Solution to Akorn allowed Sunovion to reinvest the proceeds into potential future growth opportunities. This move was part of Sunovion's strategy to focus on other therapeutic areas and products, ensuring uninterrupted access to patients for the divested product[4].

Revenue and Market Share

While specific revenue figures for XOPENEX are not provided in the sources, the drug's market share is significant within the bronchodilators segment. The asthma segment, which is a major indication for XOPENEX, accounted for the largest revenue share of 41.9% in the bronchodilators market in 2022 and is expected to grow at the fastest CAGR of 3.31% over the forecast period[1].

Clinical and Safety Profile

XOPENEX, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects, such as changes in heart rate, blood pressure, and electrocardiogram (ECG) changes. These effects are generally uncommon at recommended doses but necessitate caution in patients with cardiovascular disorders[3].

Competitive Landscape

The bronchodilators market is competitive, with several major players including products like albuterol (Proair HFA, Proventil HFA, AccuNeb, Ventolin HFA) and other combination inhalers. XOPENEX competes in this landscape by offering a specific formulation that targets the needs of patients with asthma and COPD[1].

Impact of COVID-19

The COVID-19 pandemic had a positive impact on the bronchodilators market, including XOPENEX, due to the off-label use of these drugs for inpatient treatment. The pandemic exacerbated lung conditions, increasing the demand for bronchodilators[1].

Regulatory and Market Trends

The market for bronchodilators, including XOPENEX, is influenced by regulatory approvals and the development of new formulations. For instance, several double and triple combination inhalers are in late-stage development, which could impact the market share and revenue of existing products like XOPENEX[1].

Financial Performance of Parent Companies

Sunovion Pharmaceuticals, the original developer of XOPENEX, has experienced fluctuations in its financial performance. However, the divestiture of XOPENEX Inhalation Solution allowed the company to focus on other areas of growth. Akorn, Inc., which acquired the rights to XOPENEX Inhalation Solution, has integrated this product into its portfolio of inhaled therapeutics, expanding its market presence[2][4].

Key Takeaways

• Market Growth: The global bronchodilators market, including XOPENEX, is expected to grow at a CAGR of 3.29% from 2023 to 2030.
• Segment Dominance: Beta-adrenergic bronchodilators, which include XOPENEX, dominate the market.
• Divestiture and Financial Impact: The divestiture of XOPENEX Inhalation Solution to Akorn allowed Sunovion to reinvest in growth opportunities.
• Clinical Profile: XOPENEX has a specific clinical and safety profile that necessitates caution in certain patient groups.
• Competitive Landscape: The market is competitive, with XOPENEX competing against other bronchodilators.
• COVID-19 Impact: The pandemic positively impacted the demand for bronchodilators.

FAQs

What is XOPENEX used for?

XOPENEX (levalbuterol) is used for the treatment of bronchospasm associated with asthma and chronic obstructive pulmonary disease (COPD).

Who are the current manufacturers of XOPENEX?

XOPENEX Inhalation Solution is manufactured by Akorn, Inc., while Sunovion Pharmaceuticals continues to sell XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol.

How has the COVID-19 pandemic affected the market for XOPENEX?

The COVID-19 pandemic increased the demand for bronchodilators, including XOPENEX, due to the off-label use for inpatient treatment and the exacerbation of lung conditions.

What are the potential side effects of XOPENEX?

XOPENEX can produce clinically significant cardiovascular effects, such as changes in heart rate, blood pressure, and ECG changes, especially in patients with cardiovascular disorders.

Is XOPENEX available in different formulations?

Yes, XOPENEX is available in two main formulations: XOPENEX Inhalation Solution and XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol.

Sources

1. Grand View Research: Bronchodilators Market Size & Trends Analysis Report, 2030
2. Sumitomo Pharma: Consolidated Financial Results for the Year Ended March 31, 2023
3. FDA: XOPENEX® Inhalation Solution Concentrate
4. FiercePharma: Sunovion Pharmaceuticals Inc. to Divest Xopenex® (levalbuterol HCI) Inhalation Solution to Akorn, Inc.
5. AstraZeneca: Full year and Q4 2022 results announcement