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. Twelve 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 BE PHARMS 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:	93
Clinical Trials:	16
Patent Applications:	117
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
Sunovion	N/A
Dartmouth-Hitchcock Medical Center	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	AN	RX	Yes	Yes

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	7,541,385
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	5,795,564
Lupin	BROVANA	arformoterol tartrate	SOLUTION;INHALATION	021912-001	Oct 6, 2006	6,472,563

International Patents for BROVANA

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

Country	Patent Number	Title	Estimated Expiration
Australia	722859
Canada	2333004	POLYMORPHES DU FORMOTEROL (FORMOTEROL POLYMORPHS)
Portugal	1381346
Slovenia	1446380

Market Dynamics and Financial Trajectory for Brovana

Introduction

Brovana, a long-acting bronchodilator, has been a significant player in the treatment of chronic obstructive pulmonary disease (COPD) since its launch in 2007. Here, we will delve into the market dynamics and financial trajectory of Brovana, highlighting its development, market performance, and recent changes in ownership.

Development and Launch

Brovana, with the generic name arformoterol tartrate, was developed by Sunovion Pharmaceuticals Inc., a subsidiary of Sumitomo Pharma Co., Ltd. It was approved by the FDA on October 6, 2006, and launched in the U.S. on March 28, 2007. Brovana is indicated for the long-term, twice-daily maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema, and is administered via nebulization only[1][4].

Market Position

Brovana was the first long-acting bronchodilator available for COPD patients, offering a significant advancement in treatment options. It quickly gained traction among pulmonologists and primary care physicians. According to GfK Market Measures’ COPD M.D. 2007 study, 44% of pulmonologists and 22% of primary care physicians were prescribing Brovana just three months after its launch[4].

Market Performance

The global bronchodilators market, which includes Brovana, has seen steady growth driven by the increasing prevalence of respiratory disorders such as COPD and asthma. In 2018, the global bronchodilators market was valued at $27,580 million and is expected to reach $41,487.53 million by 2026, with a CAGR of around 5%[3].

In the U.S., Brovana has been part of a competitive market dominated by other beta agonists. The U.S. sales data for beta agonists show a fluctuating but generally stable market, with Brovana contributing to this segment. For instance, in the first half of 2007, Brovana's U.S. sales were significant, though it trailed behind market leaders like Advair[4].

Financial Trajectory

The financial performance of Brovana is closely tied to the overall financial health of its parent company, Sumitomo Pharma. Here are some key financial points:

• Revenue Contribution: Brovana has been a part of Sumitomo Pharma's revenue stream, although the exact contribution is not separately disclosed. The company's overall revenue has seen fluctuations, with a decrease of 0.8% year-on-year to 555.5 billion yen in the fiscal year ending March 31, 2023[2].

• Divestiture: In October 2022, Sumitomo Pharma announced the divestiture of the U.S. market rights for Brovana and Xopenex HFA to Lupin Limited for $75 million. This move is part of Sumitomo Pharma's strategy to reallocate resources to medium to long-term growth areas and improve profitability[1].

• Impact on Financials: The divestiture of Brovana and Xopenex HFA will be recorded as other operating income in the third quarter of the fiscal year ending March 31, 2023. This transaction has already been factored into Sumitomo Pharma's financial forecast for the fiscal year[1].

New Ownership and Market Implications

With the divestiture to Lupin Limited, Brovana's market dynamics are expected to change:

• Lupin's Market Presence: Lupin is an innovation-led transnational pharmaceutical company with a strong presence in over 100 markets, including the U.S. This acquisition is expected to enhance Lupin's portfolio in the respiratory segment and leverage its global distribution network[1].

• Market Growth Potential: The transfer of ownership could lead to increased marketing efforts and potentially broader distribution channels, which might boost Brovana's market share. However, the competitive landscape in the bronchodilators market, with players like AstraZeneca and Teva Pharmaceutical Industries, will continue to be a challenge[3].

Regulatory and Safety Considerations

Brovana, like other bronchodilators, is subject to regulatory scrutiny and safety monitoring. The drug has been associated with side effects such as cardiovascular effects, nervousness, and rare cases of paradoxical bronchospasm. These factors can impact its market growth and require ongoing R&D to improve safety and efficacy[4].

Regional Market Trends

The global bronchodilators market is expected to see significant growth in the Asia-Pacific region due to an increase in respiratory disorder patient pools and improvements in healthcare infrastructure. North America, however, remains a dominant market due to high awareness and prevalence of respiratory disorders[3].

Key Takeaways

• Market Position: Brovana is a significant player in the COPD treatment market as a long-acting bronchodilator.
• Financial Performance: The drug's financial trajectory is tied to Sumitomo Pharma's overall performance, with recent divestiture to Lupin Limited.
• Market Growth: The global bronchodilators market is growing, driven by increasing prevalence of respiratory disorders.
• Regulatory and Safety: Ongoing monitoring and R&D are crucial due to associated side effects.
• New Ownership: The transfer to Lupin Limited could enhance market presence and distribution.

FAQs

What is Brovana used for?

Brovana is used for the long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema[1][4].

Who developed Brovana?

Brovana was developed by Sunovion Pharmaceuticals Inc., a subsidiary of Sumitomo Pharma Co., Ltd.[1][4].

What is the current ownership of Brovana?

As of October 2022, the U.S. market rights for Brovana have been divested to Lupin Limited[1].

What are the potential side effects of Brovana?

Brovana can cause side effects such as cardiovascular effects, nervousness, and rare cases of paradoxical bronchospasm[4].

How does Brovana fit into the global bronchodilators market?

Brovana is part of a growing global bronchodilators market, which was valued at $27,580 million in 2018 and is expected to reach $41,487.53 million by 2026[3].

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, Share and Growth Report, 2026 - Allied Market Research.
4. Brovana - MM+M - Medical Marketing and Media.