STRIVERDI RESPIMAT Drug Patent Profile

Which patents cover Striverdi Respimat, and when can generic versions of Striverdi Respimat launch?

Striverdi Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are three patents protecting this drug.

This drug has seventy-six patent family members in thirty-seven countries.

The generic ingredient in STRIVERDI RESPIMAT is olodaterol hydrochloride. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Striverdi Respimat

Striverdi Respimat was eligible for patent challenges on July 31, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 19, 2027. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for STRIVERDI RESPIMAT

International Patents:	76
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	118
Drug Prices:	Drug price information for STRIVERDI RESPIMAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STRIVERDI RESPIMAT
What excipients (inactive ingredients) are in STRIVERDI RESPIMAT?	STRIVERDI RESPIMAT excipients list
DailyMed Link:	STRIVERDI RESPIMAT at DailyMed

See drug prices for STRIVERDI RESPIMAT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for STRIVERDI RESPIMAT

Constraining patent/regulatory exclusivity:

7,727,984

NDA:

203108

Dosage:

SPRAY, METERED;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for STRIVERDI RESPIMAT

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

Sponsor	Phase
Università degli Studi di Ferrara	Phase 4
Boehringer Ingelheim

See all STRIVERDI RESPIMAT clinical trials

Pharmacology for STRIVERDI RESPIMAT

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

US Patents and Regulatory Information for STRIVERDI RESPIMAT

STRIVERDI RESPIMAT is protected by three US patents.

This potential generic entry date is based on patent 7,727,984.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	8,034,809
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	7,220,742		Y	Y
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	7,727,984			Y

Expired US Patents for STRIVERDI RESPIMAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	8,034,809
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	7,896,264
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	6,977,042

International Patents for STRIVERDI RESPIMAT

See the table below for patents covering STRIVERDI RESPIMAT around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	196682
Hungary	0302373
Saudi Arabia	936	مرشح FILTER ذو بنية مجهرية MICROSTRUCTURED

Supplementary Protection Certificates for STRIVERDI RESPIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	159 5009-2014	Slovakia		PRODUCT NAME: OLODATEROL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 14/0394/13-S 20131029; FIRST REGISTRATION: MT MA211/00401 20130918
1562603	PA2014012	Lithuania		PRODUCT NAME: OLODATEROLUM; REGISTRATION NO/DATE: LT/1/13/3429/001 LT/1/13/3429/003 LT/1/13/3429/003 LT/1/13/3429/004 20131031
1562603	C01562603/01	Switzerland		PRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014

Market Dynamics and Financial Trajectory for Striverdi Respimat

Last updated: July 29, 2025

Introduction

Striverdi Respimat (indacaterol inhalation aerosol) is a long-acting beta-agonist (LABA) marketed by Boehringer Ingelheim for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Since its FDA approval in 2014, it has carved out a strategic niche within the COPD therapeutic landscape. This analysis explores the market dynamics influencing its growth trajectory and provides a detailed overview of its financial outlook, taking recent market trends, competitive factors, and regulatory developments into account.

Market Overview and Key Drivers

Global COPD Market Landscape

The global COPD market was valued at approximately $11 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4-5% until 2030 [1]. COPD remains a leading cause of morbidity and mortality worldwide, primarily driven by tobacco use, environmental factors, and aging populations. The increased prevalence of COPD, especially in emerging markets, underpins steady demand for maintenance therapies like Striverdi Respimat.

Product Positioning and Advantages

Striverdi Respimat distinguishes itself with its once-daily dosing and inhaler design, optimized for ease of use, leading to better adherence. Its rapid onset and long duration of action make it a favorable option among clinicians, especially for patients requiring consistent bronchodilation. These attributes maintain its competitive standing in monotherapy and as part of combination regimens.

Market Penetration and Adoption Factors

While Striverdi Respimat has achieved substantial adoption in North America and Europe, its penetration in emerging markets remains limited, hindered by factors like regulatory barriers, distribution challenges, and price sensitivity. Education about inhaler technique and adherence interventions are critical drivers for expanding its usage.

Competitive Dynamics

Product Competitors

The COPD inhalation therapy market is highly competitive, dominated by several classes:

• Long-acting muscarinic antagonists (LAMAs): e.g., Tiotropium
• Long-acting beta-agonists (LABAs): e.g., Salmeterol, formoterol
• Combination therapies: e.g., LABA/ICS, LABA/LAMA, and LABA/LAMA/ICS fixed-dose combinations

Key competitors include Boehringer Ingelheim’s Spiriva (tiotropium), GlaxoSmithKline’s Trelegy Ellipta, and AstraZeneca’s Symbicort. While these options provide alternative treatment pathways, Striverdi Respimat’s once-daily monotherapy offers a unique niche, especially for patients intolerant to combination therapies or requiring maintenance monotherapy.

Regulatory and Reimbursement Landscape

Reimbursement policies significantly influence market dynamics. In regions where inhaler costs are covered, prescription rates escalate. Conversely, in markets with strict formulary controls, market share expansion hinges on clinical evidence and physician preference. Variability in regulatory approvals further impacts sales potential, with certain regions delaying approval or restricting use.

Market Challenges and Opportunities

Challenges

• Generic Competition: As patents expire, generic LABA inhalers could dilute margins unless patent protections are maintained through formulation or delivery device patents.
• Pricing Pressures: Increasing emphasis on cost-effective therapies constrains pricing power.
• Patient Adherence: Complex inhaler techniques lead to suboptimal adherence; thus, device innovation remains crucial.

Opportunities

• Expansion in Emerging Markets: Rising COPD prevalence offers growth potential, especially when coupled with strategic pricing and distribution.
• Combination Therapy Development: Developing fixed-dose combinations with other bronchodilators or inhaled corticosteroids can broaden therapeutic appeal.
• Real-World Evidence (RWE): Leveraging RWE to demonstrate clinical advantages supports market expansion and reimbursement gains.

Financial Trajectory and Revenue Outlook

Historical Performance

Since approval, Boehringer Ingelheim reports steady sales growth for Striverdi Respimat, driven by increasing COPD prevalence and product positioning. Global revenues are estimated at $400-500 million annually [2], with North America and Europe accounting for the majority share.

Forecasted Growth

Analysts project a compound annual growth rate (CAGR) of approximately 3-6% until 2030, contingent upon:

• Market penetration in emerging markets
• Regulatory approval expansion
• Introduction of combination products

The global COPD drug market’s growth trend, combined with Striverdi Respimat’s advantages, suggests a conservative but steady increase in revenue. The potential expansion into Asian markets could augment this trajectory, provided pricing strategies are aligned with local healthcare economics.

Impact of Patent Cliff and Lifecycle Management

Patent protections for original formulations typically grant exclusivity for 10-12 years post-launch. However, patent litigation and formulation patents offer extensions. Lifecycle management strategies, such as introducing next-generation inhalers or combination therapies, aim to sustain revenue streams amid generic threats.

Regulatory and Market Access Implications

Ongoing efforts to expand regulatory approvals—such as recent submissions in Japan and Brazil—are critical for expanding market access. Vaccine-style pricing negotiations and inclusion in national COPD treatment guidelines will further shape future sales.

Conclusion

Striverdi Respimat's market outlook benefits from its unique profile as a once-daily LABA monotherapy, supported by the growing global COPD burden. Market expansion hinges on regional regulatory approvals, generic competition management, and strategic positioning within combination therapy frameworks. Financially, its trajectory is poised for modest growth, reflecting broader COPD market trends and evolving therapeutic paradigms.

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Key Takeaways

• Steady Demand Drivers: Increasing COPD prevalence globally supports long-term growth potential for Striverdi Respimat.
• Competitive Edge: Once-daily dosing and inhaler design provide differentiation, but growing competition requires innovative lifecycle strategies.
• Market Expansion: Focus on emerging markets and combination therapies could significantly enhance revenue.
• Pricing and Reimbursement: Economic and policy factors remain pivotal; price optimization and reimbursement negotiations are critical.
• Pipeline and Lifecycle Management: Maintaining patent protections and developing next-generation formulations will ensure continued relevance.

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FAQs

1. How does Striverdi Respimat compare to other COPD therapies in clinical efficacy?
It offers rapid onset and sustained bronchodilation with once-daily dosing, making it competitive against other LABAs. Its efficacy is comparable within its class, with added benefits of ease-of-use and adherence.

2. What are the main barriers to market growth for Striverdi Respimat?
Barriers include patent expiration risks, competition from combination therapies and generics, regulatory delays in emerging markets, and adherence challenges linked to inhaler technique.

3. Are there ongoing efforts to develop combination formulations with Striverdi Respimat?
Yes, Boehringer Ingelheim is exploring fixed-dose combinations with other bronchodilators, which could expand therapeutic options and market segments.

4. What regions represent the highest growth opportunities for Striverdi Respimat?
Emerging markets such as China, India, and certain Latin American countries offer substantial growth potential due to rising COPD prevalence and healthcare expansion.

5. How does insurance coverage impact sales prospects for Striverdi Respimat?
Reimbursement policies directly affect prescribing behaviors; favorable coverage enhances access and adoption, while coverage gaps hinder growth, especially in cost-sensitive markets.

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Sources:
[1] MarketWatch. COPD Market Size & Trends. 2022.
[2] Boehringer Ingelheim Financial Reports. 2022.