STIOLTO RESPIMAT Drug Patent Profile

When do Stiolto Respimat patents expire, and what generic alternatives are available?

Stiolto Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-six patent family members in forty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Stiolto Respimat

Stiolto 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 STIOLTO RESPIMAT

International Patents:	156
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	3
Patent Applications:	13
Drug Prices:	Drug price information for STIOLTO RESPIMAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STIOLTO RESPIMAT
What excipients (inactive ingredients) are in STIOLTO RESPIMAT?	STIOLTO RESPIMAT excipients list
DailyMed Link:	STIOLTO RESPIMAT at DailyMed

See drug prices for STIOLTO RESPIMAT

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

Constraining patent/regulatory exclusivity:

7,727,984

NDA:

206756

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 STIOLTO RESPIMAT

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

Sponsor	Phase
HealthCore-NERI	Phase 4
Healthcore	Phase 4
Boehringer Ingelheim	Phase 4

See all STIOLTO RESPIMAT clinical trials

Pharmacology for STIOLTO RESPIMAT

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

Paragraph IV (Patent) Challenges for STIOLTO RESPIMAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STIOLTO RESPIMAT	Inhalation Spray	olodaterol hydrochloride; tiotropium bromide	2.5 mcg/2.5 mcg per spray	206756	1	2024-05-24

US Patents and Regulatory Information for STIOLTO RESPIMAT

STIOLTO RESPIMAT is protected by eight 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	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,220,742		Y	Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,396,341*PED				Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,727,984			Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,284,474*PED				Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	8,034,809
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	8,733,341		Y		Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	7,837,235*PED				Y

Expired US Patents for STIOLTO RESPIMAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,104,470
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,896,264
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,491,719
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	6,726,124
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,056,916
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	5,964,416
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	8,034,809

International Patents for STIOLTO RESPIMAT

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P980526	MICROSTRUCTURED FILTER
Spain	2170270
Germany	50103541
Australia	4829993
Estonia	04634	Meetod avaga konteineri valmistamiseks ja konteiner, mis on valmistatud sellel meetodil
Japan	5299723
Norway	328519

Supplementary Protection Certificates for STIOLTO RESPIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	PA2014012,C1562603	Lithuania		PRODUCT NAME: OLODATEROLIS, JO OPTINIAI IZOMERAI, JO ATSKIRU ENANTIOMERU ARBA RACEMATU MISINIAI, JO RUGSTIES ADITYVINES DRUSKOS SU FRAMAKOLOGINIU POZIURIU PRIIMTINOMIS RUGSTIMIS, O TAIP PAT JO SOLVATAI IR/ARBA HIDRATAI, KONKRECIAI OLODATEROLIS IR OLODATEROLIO CHLORIDAS; NAT. REGISTRATION NO/DATE: LT/1/13/3429/001, LT/1/13/3429/002, LT/1/13/3429/003, LT/1/13/3429/004 20131031; FIRST REGISTRATION: MA211/00401 20130918
1562603	C 2014 025	Romania		PRODUCT NAME: OLODATEROL, IZOMERI OPTICI INDIVIDUALI AI ACESTUIA,AMESTECURI DE ENANTIOMERI INDIVIDUALI SAU RACEMATI, SARURILE DE ADITIE ACIDA ALE ACESTORA CU ACIZI ACCEPTABILIFARMACOLOGIC, CA SI SOLVATI SI/SAU HIDRATI AI ACESTORA, IN SPECIAL OLODATEROL SI CLORHI DRAT DE OLODATEROL -6-HIDROXI-2-{[1-(4-METOXIFENIL)-1,1-DIMETILETIL]AMINO}ETIL]-2H-1,4-BENZOXAZIN-3(4H)-ONA(CACLORHIDRAT); NATIONAL AUTHORISATION NUMBER: 6414/2014/01, 6414/2014/02, 6414/2014/03, 6414/2014/04; DATE OF NATIONAL AUTHORISATION: 20140507; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MA211/00401; DATE OF FIRST AUTHORISATION IN EEA: 20130918
1562603	SPC/GB14/023	United Kingdom		PRODUCT NAME: OLODATEROL OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: MT MA 211/00401 20130918; UK PL 14598/0093 20131010
0418716	05C0039	France		PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
0418716	0290010-8	Sweden		PRODUCT NAME: TIOTROPIUM, 3BETA-(DI(2-TIENYL)HYDROXIACETOXI)-6BETA,7BETA-EPO XI-8METYL-1ALFAH,5ALFAH-TROPANIUM, ELLER ETT SALT DAERAV; NAT. REGISRTATION NO/DATE: 18094 20020503; FIRST REGISTRATION: NL RVG 26 191 20011009
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	2014/016	Ireland		PRODUCT NAME: OLODATEROL, OPTICAL ISOMERS THEREOF, MIXTURES OF ISOMERS THEREOF, ACID ADDITION SALTS THEREOF WITH PHARMACOLOGICALLY ACCEPTABLE ACIDS, AS WELL AS SOLVATES AND/OR HYDRATES THEREOF, IN PARTICULAR OLODATEROL AND OLODATEROL HYDROCHLORIDE.; NAT REGISTRATION NO/DATE: PA0775/006/001 20131018; FIRST REGISTRATION NO/DATE: MA211/00401 20130918

Market Dynamics and Financial Trajectory for STIOLTO RESPIMAT

Last updated: July 27, 2025

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Introduction

STIOLTO RESPIMAT (tiotropium bromide and olodaterol inhalation spray) emerged as a prominent combination therapy for chronic obstructive pulmonary disease (COPD) management. Developed jointly by Boehringer Ingelheim and AbbVie, this fixed-dose inhaler was approved by the U.S. Food and Drug Administration (FDA) in 2016, positioning itself as an innovative dual-bronchodilator treatment targeting COPD patients with moderate to severe symptoms. Its market performance is shaped by complex factors including competitive landscapes, evolving regulatory policies, pricing dynamics, and the growing prevalence of COPD globally.

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Market Overview and Growth Drivers

Prevalence of COPD and Patient Demographics

COPD remains a leading cause of morbidity and mortality worldwide, with over 300 million individuals affected globally [1]. The disease's progression, compounded by aging populations and increased cigarette consumption in emerging markets, drives strong demand for effective long-acting bronchodilators like STIOLTO RESPIMAT. The increasing adoption in North America, Europe, and expanding markets in Asia-Pacific catalyzes future sales growth.

Clinical Efficacy and Competitive Positioning

STIOLTO combines long-acting muscarinic antagonist (LAMA) tiotropium and long-acting β2-agonist (LABA) olodaterol. Clinical trials demonstrate its effectiveness in improving lung function and reducing COPD exacerbations compared to monotherapies [2]. Its convenient once-daily dosing and inhaler device design bolster adherence, a critical factor impacting outcomes and health economics.

Regulatory Environment and Approvals

Regulatory bodies in multiple regions have approved STIOLTO RESPIMAT, with ongoing additional approvals or label expansions expected as further clinical data emerges. Regulatory clarity enhances market confidence but also imposes compliance costs, influencing financial trajectories.

Market Dynamics

Competitive Landscape

STIOLTO RESPIMAT operates within a highly competitive COPD therapeutics market. Key competitors include:

• Spiriva (tiotropium): Market leader with a strong brand presence.
• Seebri (glycopyrronium): Another LAMA delivered via multiple inhaler devices.
• Umeclidinium and Umeclidinium/vilanterol: Developed by GlaxoSmithKline.
• Combo therapies: Ambitious pipeline entries, such as glycopyrrolate/formoterol (Gly/form) and other LABA/LAMA combinations.

The landscape is further intensified by generics and biosimilars, although inhaled formulations face barriers due to device-specific patent protections and regulatory hurdles.

Pricing and Reimbursement Trends

Pricing remains a pivotal driver of STIOLTO RESPIMAT's financial success. The inhaler’s premium positioning is justified by its clinical benefits, yet reimbursement strategies and formulary placements influence market penetration. Payers are increasingly scrutinizing high-cost combination inhalers, favoring smaller personalized treatment algorithms and cost-effective alternatives.

Market Penetration and Adoption Patterns

Early adoption concentrated in established COPD markets with high healthcare infrastructure readiness. As awareness increases, adoption curves are projected to rise, especially in regions emphasizing guideline-driven therapies. Market access challenges in lower-income countries hinge on affordability, distribution logistics, and regulatory access pathways.

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Financial Trajectory and Revenue Projections

Historical Sales Performance

Since its launch, STIOLTO RESPIMAT has experienced steady growth. According to industry reports, sales reached approximately $800 million globally in 2022, representing a compound annual growth rate (CAGR) of roughly 8% since 2017 [3]. Growth reflects the expanding patient base, increased market penetration, and clinician acceptance.

Forecasting Future Revenue

Forecast models project that STIOLTO RESPIMAT’s revenues could augment at a CAGR of 6-10% over the next five years, driven by:

• Emerging Market Expansion: Asia-Pacific and Latin America are likely to present substantial incremental opportunities as healthcare infrastructure improves and COPD awareness grows.
• Pipeline and Formulation Enhancements: Advances such as device innovations, combination formulations, and potential label expansions can extend product lifecycle and boost revenues.
• Increased Prescribing in Moderate to Severe COPD: Evolving treatment guidelines favor early and persistent use of combination therapies.

However, hurdles such as price sensitivity, patent expirations of competitors, and patent litigation could temper growth.

Impact of Patent and Market Exclusivity

Patent protections, including method-of-use and formulation patents, secure exclusivity in key markets until late 2020s. Patent expirations could introduce generic competition, eroding market share by approximately 10-20% annually [4]. Strategic lifecycle management, including line extensions and new indications, is vital to sustain revenue streams.

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Strategic Implications and Market Opportunities

Innovative Delivery Platforms

Development of next-generation inhalers with improved ease of use, portability, and dose tracking can enhance patient adherence, subsequently increasing market uptake. Digital health integration offers additional avenues for engagement and adherence monitoring.

Market Expansion Strategies

• Geographic Diversification: Entering emerging markets with tailored strategies can unlock new revenue streams.
• Biomarker-Driven Therapies: Personalized medicine approaches could refine patient selection, improving outcomes and payer acceptance.

Potential Challenges

• Regulatory Delays and Reimbursement Barriers: Slow approval processes or coverage restrictions can hinder sales.
• Competitive Innovation: Entry of new molecular entities or more effective combination products can threaten STIOLTO RESPIMAT’s market share.

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Regulatory and Economic Considerations

Adherence to evolving regulatory standards, including quality control and post-market surveillance, is essential. Cost-effectiveness analyses and real-world evidence will influence formulary placements. Collaborations with healthcare providers to demonstrate value are increasingly pursued.

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Conclusion

STIOLTO RESPIMAT stands as a significant player in the COPD treatment landscape, with a promising financial trajectory supported by demographic trends, clinical efficacy, and strategic market positioning. However, sustained growth hinges on navigating patent landscapes, pricing pressures, regulatory challenges, and competitive innovations. Stakeholders must leverage market insights, technological advancements, and tailored expansion strategies to maximize return on investment.

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Key Takeaways

• The global COPD epidemic ensures sustained demand for long-acting bronchodilators like STIOLTO RESPIMAT.
• Competitive positioning depends on efficacy, device design, adherence, and reimbursement frameworks.
• Revenue growth is projected to remain strong but tempered by patent expiration risks and market entry of new competitors.
• Strategic investments in formulation, digital health integration, and geographic expansion can drive revenues.
• Effective lifecycle management and demonstration of economic value will be crucial for maintaining market advantage.

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FAQs

1. How does STIOLTO RESPIMAT differentiate itself from competitors?
STIOLTO combines a unique inhaler device with proven dual-bronchodilator efficacy, offering convenient once-daily dosing, which enhances adherence compared to some competitors with multiple daily pills or inhalers.

2. What are the main factors influencing its market expansion?
Key factors include rising COPD prevalence, increasing adherence to clinical guidelines favoring combination therapy, regulatory approvals in new regions, and payer reimbursement policies.

3. Will patent expirations significantly impact STIOLTO’s revenues?
Patent expirations in late 2020s could introduce generic competition, potentially reducing revenues by up to 20% annually unless offset by line extensions or new indications.

4. Are there ongoing clinical trials that might expand STIOLTO’s label?
Yes, clinical trials investigating the efficacy in broader COPD severities and potential combination with other agents could facilitate label expansions, expanding market opportunities.

5. How important is digital health integration for STIOLTO’s future?
Integration of digital health tools can improve patient adherence, provide real-world effectiveness data, and serve as a competitive differentiator in a crowded market.

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Sources

1. World Health Organization. Chronic respiratory diseases. 2021.
2. Boehringer Ingelheim. STIOLTO RESPIMAT prescribing information. 2016.
3. IQVIA. The IQVIA Institute Report. 2022.
4. MarketWatch. Patent cliffs in respiratory drugs. 2022.