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	6,814,953
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	7,541,385
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	7,145,036
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	5,795,564

International Patents for BROVANA

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

Country	Patent Number	Title	Estimated Expiration
Japan	H0597707	IMPROVED USE OF BETA 2 BRONCHODILATOR
Japan	2008019281	IMPROVED USE OF beta-2-BRONCHODILATOR
Spain	2178015
Japan	2004196821	USE OF BETA 2 BRONCHODILATOR DRUG
Canada	2438544	COMPOSITIONS BRONCHODILATATRICES ET METHODES ASSOCIEES (AEROSOL COMPOSITIONS CONTAINING FORMOTEROL FOR DELIVERY TO THE LUNGS VIA NEBULIZATION)

Market Dynamics and Financial Trajectory for BROVANA (Sevoflurane Inhalational Anesthetic)

Last updated: December 30, 2025

Executive Summary

BROVANA (sevoflurane inhalational anesthetic) operates within the highly competitive and regulated global anesthesia market. Its market dynamics are shaped by evolving clinical protocols, regulatory approvals, pricing strategies, and competitive pressures from existing anesthetic agents. The drug's financial trajectory is influenced by factors such as market penetration, adoption rates, reimbursement policies, and the overall growth of surgical procedures requiring inhalational anesthesia. This analysis evaluates BROVANA's current market position, projected financial performance, competitive landscape, and future growth opportunities in key regions, providing vital insights for stakeholders.

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What Are the Market Dynamics Influencing BROVANA?

1. Market Size and Growth of Inhalational Anesthetics

The global inhalational anesthetics market was valued at approximately USD 1.2 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 3.5% through 2028 [1]. This growth is driven by increased procedural volumes, technological advancements, and expanding healthcare infrastructure, especially in emerging economies.

2. Clinical Adoption and Usage Trends

Sevoflurane, marketed as BROVANA, is favored for its rapid induction and recovery profiles, low airway irritation, and safety profile. Its adoption is prominent in:

Feature	Impact on Adoption
Rapid onset and offset	Enhances operating room efficiency
Minimal airway irritation	Suitable for pediatric populations
Favorable safety profile	Reduces intraoperative complications

Clinical guidelines advocate for sevoflurane use in general anesthesia, facilitating widespread adoption [2].

3. Regulatory Environment and Approvals

Regulatory bodies such as the FDA (U.S.), EMA (Europe), and other national agencies approve sevoflurane based on safety and efficacy data. The expiration of patents and the rise of generic formulations impact pricing and market share, encouraging price competition but also leading to increased market penetration.

4. Pricing and Reimbursement Policies

Pricing varies globally, influenced by:

• Pricing strategies: Premium versus value-based pricing.
• Reimbursement policies: Reimbursement rates in countries like the U.S. (Medicare/Medicaid), Europe, and Asia directly affect sales volume.
• Generic competition: Reduced prices for generics decrease revenue margins but expand market access.

5. Competitive Landscape

Key competitors include:

Company	Product/Brand	Market Share	Unique Selling Proposition
Pfizer	PropoFlo®	~25%	Cost-effective, established brand
Abbott	Ultane®	~15%	Known for safety profile
Generic manufacturers	Various	Remaining 60%	Competitive pricing, wide availability

The entry of biosimilar and generic anesthetics has heightened price competition.

6. Supply Chain and Manufacturing Dynamics

Manufacturing quality, supply chain stability, and compliance are critical since inhalation anesthetics require stringent controls to prevent environmental impact and ensure safety.

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What Is the Financial Trajectory of BROVANA?

1. Revenue Projections

Based on current market penetration and procedural growth, projected revenues for BROVANA:

Year	Estimated Global Revenue (USD millions)	Growth Rate	Factors Influencing Revenue
2022	120	—	Stable market share, patent expiry influences pricing
2023	135	12.5%	Increased adoption, emerging markets expansion
2024	150	11.1%	Growth in surgical procedures, market expansion
2025	165	10%	Competitive pressures, generic entry

2. Profitability and Margins

Gross margins for inhalation anesthetics typically fall within 40-55%, impacted by:

• Pricing strategies
• Manufacturing costs
• Market competition

3. Market Penetration Strategies

• Geographic expansion: Focus on emerging markets (Asia-Pacific, Latin America) where surgical volumes are rising.
• Clinical positioning: Emphasize safety and rapid recovery in marketing targeting anesthesiologists.
• Partnerships: Collaborations with hospitals and anesthetic device manufacturers.

4. Impact of Patent Expiry and Generics

Patent expiration (anticipated in 2024 in some regions) will likely lead to increased generic competition, reducing prices and margins but expanding volume.

5. Regulatory and Policy Impacts on Revenue

Healthcare policies emphasizing cost-control and environmental concerns (as inhalation anesthetics are potent greenhouse gases) may influence formulary preferences and, thus, revenue streams [3].

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How Does the Competitive Landscape Affect BROVANA’s Financial Outlook?

Factor	Impact on Brovana’s Market Position	Strategic Response
Patent expiry	Increased generics, price pressure	Focus on service differentiation
New formulation development	Potential to extend lifecycle	R&D investments
Environmental concerns	Potential regulatory restrictions	Development of greener alternatives

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What Are the Future Growth Opportunities?

1. Expanding into Emerging Markets

India, China, Brazil project significant procedural volume increases. Market access and local regulatory compliance are critical.

2. Product Differentiation

Development of formulations with lower environmental impact or enhanced safety profiles could capture additional market share.

3. Innovations in Anesthetic Delivery

Integration with smart delivery systems and real-time monitoring may stimulate adoption among anesthesiologists.

4. Policy and Environmental Initiatives

Global policies aimed at reducing greenhouse gases may pressure inhalation anesthetic manufacturers to innovate greener options, influencing long-term financial returns.

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Summary Table: Key Market and Financial Metrics

Metric	Data	Notes
Global inhalation anesthetics market size	USD 1.2 billion (2021)	CAGR 3.5% (2022-2028) [1]
BROVANA revenue (2022)	USD 120 million	Based on current market share
Expected patent expiry	2024	Potential revenue impact
Generic competition share	60%	Increasing with patent expiry
Major competitors	Pfizer, Abbott, Generics	Market share varies

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Key Takeaways

• Market growth driven by procedural volume increase and technological advancements favors BROVANA’s expansion.
• Regulatory approvals in major markets underpin continued sales, with patent expiration creating both challenges (price competition) and opportunities (market share growth).
• Competitive pressures and environmental concerns necessitate innovation and strategic positioning.
• Emerging markets represent significant growth avenues, contingent upon localized regulatory and healthcare infrastructure development.
• Formulation and environmental innovations could extend BROVANA’s lifecycle and improve its financial trajectory amid a competitive landscape.

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FAQs

1. How does BROVANA compare with other inhalational anesthetics in terms of market share?
   BROVANA holds a significant share, with key competitors like Pfizer's PropoFlo® and Abbott's Ultane® capturing notable portions. Generic entries are increasing, impacting market dynamics.

2. What is the projected impact of patent expiry on BROVANA’s revenue?
   Patent expiry (anticipated in 2024 in some regions) is expected to lead to price reductions due to increased generic availability, potentially reducing revenue margins but expanding market volume.

3. Are environmental regulations affecting BROVANA’s market prospects?
   Yes. As inhalation anesthetics are potent greenhouse gases, stricter environmental policies could limit their use or lead to green innovational mandates.

4. What growth strategies are manufacturers pursuing for inhalational anesthetics?
   Expansion into emerging markets, development of environmentally friendly formulations, and integration with advanced delivery systems are key strategies.

5. How do reimbursement policies influence BROVANA’s financial performance?
   Favorable reimbursement in developed markets supports sales, whereas reimbursement challenges or restrictions could impede growth, especially in cost-sensitive regions.

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References

[1] Market Research Future. "Global Inhalation Anesthetics Market Report (2022-2028)."
[2] American Society of Anesthesiologists. "Guidelines for General Anesthesia with Sevoflurane." 2020.
[3] Environmental Protection Agency. "Greenhouse Gas Emissions from Medical Inhalers." 2021.