BROVANA Drug Patent Profile

When do Brovana patents expire, and when can generic versions of Brovana launch?

Brovana is a drug marketed by Lupin and is included in one NDA.

The generic ingredient in BROVANA is arformoterol tartrate. There are four drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the arformoterol tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brovana

A generic version of BROVANA was approved as arformoterol tartrate by CIPLA on June 22^nd, 2021.

Summary for BROVANA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	232
Drug Prices:	Drug price information for BROVANA
What excipients (inactive ingredients) are in BROVANA?	BROVANA excipients list
DailyMed Link:	BROVANA at DailyMed

See drug prices for BROVANA

Recent Clinical Trials for BROVANA

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
Dartmouth-Hitchcock Medical Center	N/A
Sunovion	N/A

See all BROVANA clinical trials

Pharmacology for BROVANA

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

Paragraph IV (Patent) Challenges for BROVANA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BROVANA	Inhalation Solution	arformoterol tartrate	Eq. 0.015 mg base/ 2 mL	021912	1	2009-10-01

US Patents and Regulatory Information for BROVANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006		DISCN	Yes	No

Expired US Patents for BROVANA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,720,453
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	7,541,385
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	7,462,645
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	5,795,564
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,814,953

International Patents for BROVANA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0021487
Portugal	1446380
Germany	4209989
Australia	2002244211
Netherlands	9200629

Market Dynamics and Financial Trajectory for BROVANA (Arformoterol Tartrate)

Last updated: July 27, 2025

Introduction

BROVANA (arformoterol tartrate) is a long-acting β2-adrenergic receptor agonist (LABA) primarily used as a bronchodilator for chronic obstructive pulmonary disease (COPD). Approved by the U.S. Food and Drug Administration (FDA) in 2009, BROVANA represents a significant segment within respiratory therapeutics, with its market positioning influenced by evolving clinical guidelines, competitive landscape, and healthcare reimbursement patterns. This analysis explores the current market dynamics and forecasts the financial trajectory of BROVANA within the broader respiratory drugs sector.

Product Overview and Clinical Positioning

Arformoterol functions by inducing smooth muscle relaxation in the airways, improving airflow, and reducing COPD exacerbations. It is typically prescribed for maintenance therapy in moderate to severe COPD cases, often in combination with other inhaled agents. BROVANA’s unique formulation as a nebulized solution offers advantages for certain patient populations, such as those with difficulty using inhalers — including elderly or severely ill patients.

Despite its clinical efficacy, BROVANA faces competition from inhalers delivering similar long-acting bronchodilators, including both LABAs and long-acting muscarinic antagonists (LAMAs). The choice of therapy increasingly depends on device preference, reimbursement policies, and physician prescribing trends tailored to patient needs.

Market Dynamics Shaping BROVANA's Trajectory

1. Competitive Landscape in COPD Therapy

The global COPD therapeutics market is dominated by major pharmaceutical players like GlaxoSmithKline, AstraZeneca, Novartis, and Boehringer Ingelheim, offering inhaler-based LABAs such as Flovent (fluticasone), Breo Ellipta (vilanterol/fluticasone), and Spiriva (tiotropium). BROVANA, as a nebulized option, occupies a niche role, often prescribed to patients with inhaler intolerance.

The inhaler device paradigm has gained prominence over nebulized therapies due to convenience and portability. Consequently, BROVANA’s market share remains constrained, although its utility persists in specialized settings.

2. Regulatory and Reimbursement Environment

Regulatory approvals beyond initial indications, such as Expanded Labeling or clinical trial data demonstrating comparative effectiveness, influence market acceptance. Reimbursement policies tend to favor inhaler therapies due to lower costs and established distribution channels, adversely impacting nebulized treatments like BROVANA.

Additionally, formulary inclusion and insurance coverage significantly impact prescribing behaviors, especially in competitive healthcare markets like the U.S., Europe, and Asia.

3. Clinical Adoption and Prescriber Preferences

Prescribers favor inhaler therapies for their ease of use and patient adherence potential. However, BROVANA still maintains relevance in specific patient populations—those with severe COPD, cognitive or physical impairments, or in hospital outpatient settings. The treatment landscape's evolution emphasizes personalized medicine, which can either hinder or bolster BROVANA’s utilization depending on clinical guidelines.

4. Market Penetration and Growth Opportunities

While BROVANA’s sales have historically been modest compared to inhaler-based formulations, niche growth persists owing to its nebulized delivery, especially with the rising prevalence of COPD globally and an aging population. The increasing burden of respiratory diseases in emerging markets presents potential expansion avenues, provided regulatory hurdles are addressed.

5. Impact of Biosimilars and Innovation

The advent of biosimilars and novel drug delivery systems introduces cost pressures and competitive challenges. Nonetheless, innovations like fixed-dose combinations and extended-release formulations continue to influence market dynamics, potentially affecting BROVANA’s market share.

Financial Trajectory Analysis

1. Revenue Generation and Market Shares

Historically, BROVANA's revenue has stabilized at a modest level, aligning with its status as a niche product. In 2022, estimates placed its global sales in the low hundreds of millions USD. Its market share in the COPD maintenance segment remains small, typically under 5% in major markets, constrained by competitive inhalers and reimbursement policies.

2. Growth Drivers

• Expansion in Emerging Markets: Increasing COPD prevalence in Asia-Pacific and Latin America offers growth opportunities, contingent upon regulatory approval and local pricing strategies.
• Hospital and Specialty Settings: Usage in hospitals, especially for patients with inhaler limitations, can sustain or modestly grow sales.
• Clinical Evidence and Label Expansion: New clinical data supporting efficacy in adjunctive or alternative indications could unlock sales avenues.

3. Challenges and Risks

• Device Preference Shift: The mainstream adoption of inhalers hampers nebulized therapy growth.
• Cost Containment Pressures: Price sensitivity and healthcare cost containment measures threaten profit margins.
• Regulatory Hurdles: The need for local approvals and adherence to evolving standards limits rapid geographic expansion.

4. Forward-Looking Forecasts

Analysts projects a slow-to-moderate growth trajectory for BROVANA over the next five years. Compound annual growth rate (CAGR) estimates range from 1-3%, primarily driven by market penetration in emerging regions and hospital settings. Significant growth hinges on strategic positioning, clinical validation, and successful navigation of reimbursement landscapes.

Strategic Considerations for Stakeholders

Investors and healthcare companies should monitor regulatory developments, device innovations, and shifting prescribing trends. Commercial strategies that emphasize niche applications, such as periodic hospital use or specific patient subgroups, can sustain revenues. Collaboration with payers for formulary access and differentiation via clinical data remains vital.

Key Takeaways

• Limited Market Share: BROVANA occupies a niche position within the COPD therapeutic landscape, with limited market penetration compared to inhaler-based therapies.
• Growth Prospects in Emerging Markets: Expansion in Asia-Pacific and Latin America driven by rising COPD prevalence offers potential upside, contingent on regulatory and pricing strategies.
• Device and Prescriber Trends: Preference for inhalers in COPD management constrains nebulized options; however, specialized patient needs maintain certain demand.
• Competitive and Reimbursement Pressures: Cost containment, biosimilar emergence, and reimbursement policies may put downward pressure on sales.
• Long-Term Outlook: Modest growth projected, emphasizing the importance of clinical differentiation, strategic geographic expansion, and targeted niche marketing.

FAQs

1. What clinical advantages does BROVANA offer over inhaler-based therapies?
BROVANA’s nebulized formulation benefits patients with severe COPD, cognitive impairments, or difficulty using inhalers, offering effective drug delivery in these populations.

2. How does reimbursement influence BROVANA’s market share?
Reimbursement policies favor inhaler therapies due to cost-effectiveness and convenience, limiting BROVANA’s uptake unless specific patient needs justify nebulized treatment.

3. What are the key competitors to BROVANA?
Main competitors include inhaler-based LABAs like Vilanterol (BreO Ellipta), Salmeterol, and Tiotropium. These products dominate COPD maintenance therapy markets globally.

4. Can BROVANA expand into new therapeutic areas?
Current indications are specific to COPD. Off-label or new indications would require clinical trials and regulatory approval, which are unlikely in the short term.

5. What strategies could enhance BROVANA’s future growth?
Focusing on emerging markets, enhancing clinical data, targeting hospital and niche patient populations, and establishing favorable formulary positions could bolster sales.

References

[1] U.S. Food and Drug Administration. BROVANA (arformoterol tartrate) inhalation solution FDA approval letter, 2009.
[2] GlobalData. COPD Market Analysis, 2022.
[3] IQVIA. Pharmaceutical Market Reports, 2022.
[4] PubMed. Clinical trials and efficacy data on BROVANA, 2010-2022.
[5] European Medicines Agency. Regulatory overview of long-acting β2-agonists, 2021.