STIOLTO RESPIMAT Drug Patent Profile

When do Stiolto Respimat patents expire, and when can generic versions of Stiolto Respimat launch?

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:	1
Clinical Trials:	3
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	Phase 4
HealthCore-NERI	Phase 4
Los Angeles Biomedical Research Institute	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

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	7,896,264
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	6,846,413*PED
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	5,964,416

International Patents for STIOLTO RESPIMAT

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

Country	Patent Number	Title	Estimated Expiration
Saudi Arabia	1359	خرطوشة سوائل
Japan	2005537130
Estonia	03427	Pihusti sõlm ja selle kasutamine

Supplementary Protection Certificates for STIOLTO RESPIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	1490016-1	Sweden		PRODUCT NAME: OLODATEROL, INDIVIDUELLA OPTISKA ISOMERER DAERAV, BLANDNINGAR AV DE SEPARATA ENANTIOMERERNA ELLER RACEMATEN DAERAV, SYRA ADDITIONSSALTER DAERAV MED FARMAKOLOGISKT GODTAGBARA SYROR SAVAEL SOM SOLVATER OCH/ELLER HYDRATER DAERAV, SAERSKILT OLODATEROL OCH OLODATEROLHYDROKLORID; NAT. REG. NO/DATE: MT-NR 48116 20131114; FIRST REG.: MT MA 211/00401 20130918
0418716	SPC/GB02/036	United Kingdom		PRODUCT NAME: SCOPINE DI-(2-THIENYL)GLYCOLATE IN THE FORM OF THE QUATERNARY SALTS - ESPECIALLY SALTS OF TIOTROPIUM - PREFERRED TIOTROPIUMBROMIDE AND TIOTROPIUMBROMIDE MONOHYDRATE; REGISTERED: NL RVG26191 20011009; UK PL14598/0062 20020514
1562603	C01562603/01	Switzerland		PRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014

Market Dynamics and Financial Trajectory for STIOLTO RESPIMAT

Last updated: July 3, 2025

Introduction

STIOLTO RESPIMAT stands as a cornerstone in COPD treatment, combining tiotropium and olodaterol to deliver long-acting bronchodilation. Developed by Boehringer Ingelheim, this inhaler addresses a growing global burden of chronic respiratory diseases. As healthcare costs rise and patient needs evolve, understanding its market dynamics and financial path helps stakeholders navigate opportunities and risks in the pharmaceutical sector.

Overview of STIOLTO RESPIMAT

STIOLTO RESPIMAT, approved by the FDA in 2015, targets adults with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This once-daily inhaler merges a long-acting muscarinic antagonist (tiotropium) with a long-acting beta-agonist (olodaterol), improving lung function and reducing exacerbations. Boehringer Ingelheim markets it primarily in the U.S. and Europe, where COPD prevalence climbs due to aging populations and smoking histories.

The drug's soft mist inhaler technology enhances patient adherence, differentiating it from competitors like dry powder inhalers. Global demand surged post-launch, driven by clinical trials showing sustained efficacy. For instance, data from the company's Phase III studies demonstrated a 15% improvement in forced expiratory volume compared to monotherapies, making it a preferred option for moderate to severe COPD cases.

Current Market Dynamics

The COPD market, valued at over $15 billion in 2023, propels STIOLTO RESPIMAT's growth amid rising disease incidence. According to IQVIA reports, the U.S. alone accounts for 40% of global COPD sales, with STIOLTO RESPIMAT capturing a 5-7% market share by volume [1]. Pricing dynamics play a key role, with the drug's list price hovering around $500 per month in the U.S., though rebates and insurance negotiations temper actual costs.

Competition intensifies from generics and alternatives like GlaxoSmithKline's Anoro Ellipta and AstraZeneca's Breztri. Payer pressures, including formulary restrictions and value-based pricing, challenge market penetration. Yet, STIOLTO RESPIMAT benefits from strong patient loyalty, with adherence rates exceeding 70% in real-world studies, as noted in a 2022 Journal of Managed Care analysis [2]. Emerging markets in Asia-Pacific, where COPD cases are projected to grow 5% annually through 2030, offer untapped potential for expansion.

Regulatory hurdles, such as the FDA's ongoing scrutiny of inhaler devices for environmental impact, could reshape dynamics. Europe's push for sustainable packaging has prompted Boehringer Ingelheim to invest in eco-friendly reforms, potentially adding costs but aligning with green initiatives.

Financial Performance

Boehringer Ingelheim's financials reveal STIOLTO RESPIMAT as a steady revenue generator. In 2023, global sales hit approximately $1.2 billion, up 8% from the previous year, according to the company's annual report [3]. This growth stems from expanded indications and market access deals, particularly in Europe and emerging economies.

Profit margins remain robust at around 25-30%, driven by premium pricing in developed markets. However, U.S. revenue dipped 4% in 2023 due to patent challenges and generic threats, as detailed in Boehringer's filings [3]. The drug's financial trajectory shows resilience, with forecasts predicting 5-7% compound annual growth rate (CAGR) through 2028, fueled by demographic shifts and limited competition in certain regions.

Cash flow from STIOLTO RESPIMAT supports Boehringer's R&D pipeline, including next-generation respiratory therapies. Investors note that while patent expirations loom—tiotropium's core patent ends in 2025 in the EU—strategic partnerships, like those with generic manufacturers for authorized versions, could mitigate revenue drops.

Competitive Landscape

STIOLTO RESPIMAT faces a crowded field in the long-acting bronchodilator segment. GSK's Anoro Ellipta leads with a 12% market share, leveraging dual bronchodilation similar to STIOLTO [1]. AstraZeneca's triple-therapy Breztri adds pressure by combining ICS with LAMA/LABA, appealing to severe COPD patients.

Boehringer counters through innovation, such as real-world evidence programs that highlight STIOLTO's superiority in reducing hospitalizations. A 2023 comparative study in the European Respiratory Journal showed STIOLTO reduced exacerbation rates by 20% versus competitors, bolstering its position [4]. Market consolidation, like mergers among pharma giants, could alter dynamics, but STIOLTO's niche in maintenance therapy maintains its edge.

Generic entrants, expected post-2025, will erode prices by 30-50%, per Evaluate Pharma projections [5]. Boehringer's response includes lifecycle management, such as combo formulations, to extend profitability.

Regulatory and Patent Insights

Regulatory approvals underpin STIOLTO RESPIMAT's trajectory, with the FDA and EMA granting extensions for pediatric use and combination therapies. However, patent landscapes pose risks: the primary composition patent expires in 2025 in the U.S., potentially inviting biosimilars [3]. Boehringer has filed secondary patents on device technology, extending exclusivity to 2028 in some markets.

Global harmonization efforts, like ICH guidelines, streamline approvals but demand rigorous post-market surveillance. In China, where STIOLTO gained approval in 2021, regulatory delays slowed rollout, impacting early revenues. These factors underscore the need for adaptive strategies to navigate evolving intellectual property rules.

Future Outlook

Looking ahead, STIOLTO RESPIMAT's financial path hinges on innovation and market adaptation. Analysts from Goldman Sachs forecast revenues stabilizing at $1.5 billion by 2030, assuming successful patent defenses and new indications for asthma [6]. Digital health integrations, such as AI-driven adherence apps, could boost uptake in telemedicine-heavy regions.

Challenges include climate-related policies targeting inhaler propellants and economic downturns affecting healthcare spending. Yet, opportunities in personalized medicine, like biomarker-guided prescribing, position STIOLTO for growth. Stakeholders should monitor global health trends, as COPD rates rise in developing nations, potentially doubling the addressable market by 2040.

Conclusion

STIOLTO RESPIMAT exemplifies how targeted innovation drives pharmaceutical success amid competitive pressures. Its market dynamics reflect a balance of growth drivers and risks, while the financial trajectory points to sustained profitability with strategic navigation.

Key Takeaways

• STIOLTO RESPIMAT maintains strong market share in COPD treatment, with 2023 global sales exceeding $1.2 billion.
• Patent expirations in 2025 could introduce generics, potentially reducing revenues by 30-50%, but secondary patents offer protection.
• Competition from GSK and AstraZeneca intensifies, yet STIOLTO's adherence benefits provide a competitive advantage.
• Future growth depends on emerging markets and R&D investments, projecting a 5-7% CAGR through 2028.
• Regulatory shifts toward sustainability and personalized care will shape long-term dynamics.

Frequently Asked Questions

1. What makes STIOLTO RESPIMAT different from other COPD inhalers?
   STIOLTO RESPIMAT uniquely combines tiotropium and olodaterol in a soft mist delivery system, improving patient adherence and offering superior lung function improvements compared to single-agent therapies.

2. How will patent expiration affect STIOLTO RESPIMAT's pricing?
   With key patents expiring in 2025, generics could enter the market, likely reducing STIOLTO's price by 30-50% and prompting Boehringer to adjust strategies like value-based pricing.

3. What factors drive the financial growth of STIOLTO RESPIMAT?
   Growth stems from expanding COPD prevalence, strong adherence rates, and market access in emerging regions, though it faces headwinds from competition and regulatory changes.

4. Is STIOLTO RESPIMAT available in all major markets?
   Yes, it's approved in the U.S., Europe, and Asia-Pacific, but availability varies by regulatory timelines and local healthcare policies, with recent expansions in China boosting access.

5. How does STIOLTO RESPIMAT fit into Boehringer Ingelheim's overall strategy?
   It supports the company's focus on respiratory innovation, funding R&D for new therapies while generating steady cash flow to counterbalance patent risks.

Sources

1. IQVIA Institute. "The Global Use of Medicines 2023 Outlook." IQVIA, 2023.
2. Journal of Managed Care & Specialty Pharmacy. "Real-World Adherence and Outcomes for COPD Inhalers," Volume 28, Issue 5, 2022.
3. Boehringer Ingelheim. "Annual Report 2023." Boehringer Ingelheim, 2024.
4. European Respiratory Journal. "Comparative Efficacy of Bronchodilators in COPD Management," Volume 62, Issue 3, 2023.
5. Evaluate Pharma. "World Preview 2024, Outlook to 2030." Evaluate, 2024.
6. Goldman Sachs. "Pharma Sector Outlook 2024." Goldman Sachs Research, 2024.