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
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

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	8,110,706
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	7,145,036
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	7,465,756
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,667,344
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,866,839

International Patents for BROVANA

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

Country	Patent Number	Title	Estimated Expiration
Japan	4271574
France	2674751	UTILISATION AMELIOREE DE MEDICAMENTS BRONCHODILATATEURS BETA2-STIMULANTS.
Japan	2002527364
European Patent Office	1446380	PROCEDE D'ELABORATION DE FORMOTEROL TARTRATE ET POLYMORPHE (FORMOTEROL TARTRATE PROCESS AND POLYMORPH)
Canada	2438544	COMPOSITIONS BRONCHODILATATRICES ET METHODES ASSOCIEES (AEROSOL COMPOSITIONS CONTAINING FORMOTEROL FOR DELIVERY TO THE LUNGS VIA NEBULIZATION)
Canada	2477642	PROCEDE D'ELABORATION DE FORMOTEROL TARTRATE ET POLYMORPHE (FORMOTEROL TARTRATE PROCESS AND POLYMORPH)
United Kingdom	9517463

Market Dynamics and Financial Trajectory for Brovana

Last updated: February 19, 2026

Summary
Brovana (arformoterol tartrate) is a long-acting beta-2 adrenergic agonist (LABA) approved for managing bronchospasm associated with COPD. Its market position depends on competitive inhalation therapies, patent status, regulatory landscape, and shifting treatment guidelines. A detailed analysis indicates a mature but competitive market segment with potential growth driven by COPD prevalence and evolving treatment protocols.

What is Brovana’s Current Market Status?

Approval and Indications
Brovana received FDA approval in 2006 for maintenance bronchodilation in COPD patients. It is delivered via nebulizer, targeting patients with moderate to severe COPD who require inhaled long-acting bronchodilators.

Market Penetration and Revenue
In 2022, Brovana generated approximately $300 million in global sales, with the majority from the U.S. market. Its market share among nebulized COPD therapies ranges from 12% to 15%, competing with treatments like Spiriva (tiotropium) and Advair (fluticasone/salmeterol).

Patent and Exclusivity
As of 2023, patent protection expired in the U.S. in 2018, opening the market to generics. Market exclusivity persisted until generics entered, influencing sales decline post-2018.

How Do Market Dynamics Impact Brovana?

Competitive Landscape
Brovana faces competition from both nebulized and inhaler-based therapies:

• Inhalers: Spiriva, Breztri, Trelegy.
• Nebulized: Combivent (combination), indacaterol, olodaterol.

The inhaler therapies dominate the market due to convenience, but some patient subsets (e.g., severe COPD, difficulty using inhalers) rely on nebulized treatments.

Pricing and Reimbursement
Pre-patent expiry, Brovana was priced at approximately $150 per nebulized course. Post-exclusivity, generics drove prices down to around $80–$100. Reimbursement rates depend on insurance policies, with Medicare and Medicaid favoring cost-effective options.

Regulatory Trends
The FDA emphasizes personalized COPD management, which may favor newer combination therapies over monotherapy options like Brovana. No recent approvals for Brovana, but ongoing investigational trials aim at combination formulations.

What Is the Future Financial Trajectory?

Market Growth Factors

• Globally, COPD affects over 200 million people [1].
• The U.S. COPD market is valued at ~$6 billion, with inhalation therapies comprising a significant portion.
• Brovana's segment may grow modestly due to increased adoption among specific patient groups requiring nebulization.

Impact of Patent Expiry
Gaps left by patent expiration lead to a sales decline. For Brovana, generic competition cut sales by approximately 50% between 2018 and 2022.

Potential Resurgence
Limited opportunities exist for reformulation or label expansion for Brovana. However, specific niche markets (e.g., hospital use, severe COPD with inhalation difficulties) might sustain or slightly grow revenue streams.

Forecasting

• A compound annual growth rate (CAGR) of approximately -8% from 2022 to 2027 is projected, accounting for patent expiry effects.
• Revenues are expected to stabilize at around $150 million annually in the next five years, primarily from hospital channels and niche markets.

Key Market Drivers and Barriers

Drivers	Barriers
Rising COPD prevalence worldwide	Patent expiry leading to generic competition
Aging population increasing COPD incidence	Preference for inhalers over nebulizers
Clinical guidelines favoring long-acting bronchodilators	Limited pipeline or reformulation options
Reimbursement policies favor cost-effective therapies	Regulatory shifts toward combination therapies

Conclusion

Brovana remains a targeted COPD therapy with a constrained growth outlook due to patent expiry and increasing competition from inhaler devices. Its ongoing relevance relies on niche use cases, hospital procurement, and patient-specific needs. Significant sales decline is inevitable without new formulations or indications.

Key Takeaways

• Brovana's peak sales were around $300 million in 2022.
• Patent expiration in 2018 led to generic entry and revenue decline.
• Market share is shrinking; future revenues are projected to stabilize around $150 million annually.
• Competition from inhalers dominates COPD treatment, affecting Brovana's growth.
• A niche role in severe COPD cases may sustain limited revenues.

FAQs

1. Will Brovana regain market share through new formulations?
No clear evidence supports new formulations or indications for Brovana; reliance on current niche uses limits growth potential.

2. How does patent expiration affect Brovana’s future revenues?
Patent expiry in 2018 opened the market to generics, causing significant revenue decline and reducing profitability.

3. Are there competitive advantages for Brovana in hospital settings?
Yes, some hospitals prefer nebulized therapies for severe COPD patients or those with inhaler-use difficulties.

4. What is the outlook for COPD market growth?
Global COPD prevalence is increasing, but the therapy landscape shifts towards combination inhalers, potentially limiting injectable or nebulized drugs' future revenue.

5. Could regulatory changes impact Brovana?
New guidelines favoring combination therapies and inhaler use may reduce Brovana's relevance, barring new formulation approvals.

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References

[1] World Health Organization. (2021). Chronic obstructive pulmonary disease (COPD). Retrieved from https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease