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:	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

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
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.

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			Y	Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes				Y
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes					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
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015

International Patents for STIOLTO RESPIMAT

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

Country	Patent Number	Title	Estimated Expiration
Argentina	027775	PROCEDIMIENTO PARA FABRICAR UN RECIPIENTE PROVISTO DE UNA ABERTURA DE COMPENSACION DE PRESION Y RECIPIENTE FABRICADO SEGUN ESTE PROCEDIMIENTO
Bulgaria	102345
Estonia	04518	Padrun vedeliku jaoks
Canada	2145758	AJUTAGE DE PULVERISATION AVEC FILTRE, ET DISPOSITIF DE PULVERISATION LES INCORPORANT (ATOMISING NOZZLE AND FILTER AND SPRAY GENERATING DEVICE)

Supplementary Protection Certificates for STIOLTO 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	14C0049	France		PRODUCT NAME: OLODATEROL, SES ISOMERES OPTIQUES INDIVIDUELS, MELANGES D'ENANTIOMERES INDIVIDUELS OU RACEMATE, SES SELS D'ADDITION D'ACIDE AVEC DES ACIDES PHARMACOLOGIQUEMENT ACCEPTABLES, AINSI QUE DES SOLVATES ET OU HYDRATES, EN PARTICULIER OLODATEROL OU CHLORHYDRATE D'OLODATEROL; NAT. REGISTRATION NO/DATE: NL42395 20140522; 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	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

Market Dynamics and Financial Trajectory for STIOLTO RESPIMAT

Last updated: December 26, 2025

Executive Summary

STIOLTO RESPIMAT (containing tiotropium bromide and olodaterol) is an inhaled combination medication targeting chronic obstructive pulmonary disease (COPD) management. Its market debut in 2018 has positioned it as a crucial therapy amid rising COPD prevalence globally. This report evaluates the current market landscape, growth drivers, competitive dynamics, revenue trajectories, and future outlook concerning STIOLTO RESPIMAT, providing vital insights for stakeholders.

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What Is the Pharmacological Profile of STIOLTO RESPIMAT?

Component	Action	Indications
Tiotropium bromide	Long-acting muscarinic antagonist (LAMA)	COPD maintenance therapy
Olodaterol	Long-acting β2-agonist (LABA)	COPD symptom control

Market Authorization & Approvals:

• Approved by the U.S. Food and Drug Administration (FDA) in 2018 for COPD treatment.[1]
• EMA approval followed in Europe (2019).
• Approved for use in multiple markets, including Japan, Canada, Australia, and Brazil.

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What Are the Key Market Drivers for STIOLTO RESPIMAT?

Rising COPD Prevalence and Disease Burden

Region	COPD Prevalence (millions)	CAGR (2018–2025)	Major Drivers
North America	14.8	4.2%	Aging population, smoking rates
Europe	12.3	4.0%	Urbanization, environmental pollution
Asia-Pacific	49.4	10.5%	Rapid urban growth, tobacco consumption

Source: Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2022 report[2]._

Growth in Inhaled Long-Acting COPD Therapies

• Increasing adoption of combination inhalers (LAMA/LABA) over monotherapy.[3]
• The convenience of dual therapy enhances adherence and clinical outcomes.

Competitive Landscape & Market Share

Key Players	Product(s)	Market Share (2022)	Notes
GlaxoSmithKline (GSK)	STIOLTO RESPIMAT	Approx. 15%	First in class LAMA/LABA combination inhaler in multiple markets
Boehringer Ingelheim	Spiriva (tiotropium)	35%	Widely used monotherapy; competition from combination inhalers
Novartis	Ultibro Breezhaler (indirect competitor)	10%	Combo therapies available through other delivery devices

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How Has STIOLTO RESPIMAT's Sales Trajectory Developed?

2018: Market Entry and Initial Adoption

• Launched in the US, Europe, Japan, and select markets.
• Initial sales modest but steadily increasing, driven by physician familiarity with tiotropium and olodaterol monotherapies.

2019–2021: Steady Growth Period

• Annual sales grew approximately 20% year-over-year globally.
• Adoption particularly strong in North America and Europe, where COPD prevalence is high and healthcare policies favor inhaler therapies.

2022: Market Penetration and Revenue Estimates

Region	Estimated Global Sales (2022)	Market Share (Estimated)	Revenue (USD millions)
North America	$250	35%
Europe	$180	25%
Asia-Pacific	$100	15%
Rest of World	$70	10%
Total	$600

Note: These figures are estimates based on IMS Health sales data and industry reports.[4]

Revenue Drivers and Growth Factors

• Expanding prescription volume due to COPD management guidelines.[5]
• Incremental growth driven by new market approvals and expanding indications.
• Price adjustments reflecting inflation, reimbursement policies, and clinical evidence updates.

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What Are the Key Factors Influencing Market Dynamics?

Regulatory and Reimbursement Policies

Region	Policy Impact	Status
US (FDA)	Favorable reimbursement for COPD inhalers; competitive pricing policies	Positive
Europe (EMA)	Reimbursement varies by country; some regions favor dual therapies	Mixed
Japan	Introduction of new inhaler devices and reimbursement pathways	Increasing adoption

Clinical Data & Real-World Evidence (RWE)

• Studies endorse the efficacy and safety profile of STIOLTO RESPIMAT.
• Real-world studies demonstrate improved adherence rates compared to monotherapies.[6]

Competitive Innovations & Pipeline Products

Competitor Product(s)	Features	Differentiators
Trelegy Ellipta (GSK)	Triple therapy (LAMA/LABA/ICS)	Once-daily dosing, high efficacy
Other generic inhalers	Price competition	Cost-effectiveness

Patent and Intellectual Property Landscape

• Patent protections for STIOLTO RESPIMAT extend until at least 2030, encouraging sustained revenues.[7]
• Key patents cover device design, formulation stability, and delivery mechanisms.

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How Do Competitive Dynamics and Market Segments Evolve?

Segment	Characteristics	Growth Potential
Prescriptions (Rx)	Majority from pulmonologists, primary care	Continued growth with aging populations
Institutional Use	Hospital and clinic settings	Growing with COPD exacerbation management
Pharmacist Dispensing	Increasing in some markets due to OTC policies	Moderate but increasing

Market Share by Delivery Device:

• Respimat Soft Mist inhaler: dominant in prescribed COPD therapies.
• Devices are increasingly being optimized for patient adherence and ease of use.

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Future Outlook: Pathways and Projections

Market Forecast (2023–2028)

Year	Estimated Sales (USD millions)	Compound Annual Growth Rate (CAGR)	Drivers
2023	$650	8.7%	Ongoing COPD prevalence, expanding formulary inclusion
2024	$710	9.2%	Increased uptake, new market entries
2026	$835	8.0%	Penetration in emerging markets
2028	$950	7.5%	Broader indications, improved clinical guidelines

Potential Limitations and Risks

• Pricing Pressures: Reimbursement restrictions in developed markets may cap revenue growth.[8]
• Generic Competition: Entry of cheaper alternatives could erode market share.
• Regulatory Changes: Stringent regulatory policies could delay approvals.

Strategic Opportunities

Opportunity	Rationale	Implementation Considerations
Geographic Expansion	Emerging markets show high COPD burdens	Tailored pricing, localized marketing
Formulation Innovation	Once-daily fixed-dose combinations improve adherence	R&D investments in delivery technology
Combination with Emerging Therapies	Potential for triple or quadruple combinations	Clinical trial investment, partnerships

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Summary Table: Financial and Market Summary

Aspect	Details
Market Size (2022)	~$600 million globally
Key Growth Drivers	COPD prevalence, dual inhaler adoption, guideline updates
Leading Competitors	GSK, Boehringer Ingelheim, Novartis
Revenue Trajectory (2023–2028)	Estimated CAGR: ~8-9%
Patent Expiry (Approximate)	2030–2035 (patent protections)

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Key Takeaways

• STIOLTO RESPIMAT has established itself as a prominent dual therapy for COPD, with steady growth driven by rising prevalence and evolving treatment guidelines.
• Market dynamics favor combination inhalers, with competitors intensifying efforts via triple therapies and innovative devices.
• Regulatory, reimbursement, and patent landscapes significantly influence revenues.
• Emerging markets present substantial growth opportunities; strategic expansion and innovation are key to maintaining competitive advantage.
• Continued clinical research, real-world evidence, and patient-centric device improvements will bolster long-term market position.

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FAQs

1. What differentiates STIOLTO RESPIMAT from other COPD inhalers?
   Its combination of tiotropium and olodaterol in the Respimat device offers extended symptom control with convenience, improving adherence and outcomes.

2. How does patent protection influence STIOLTO RESPIMAT’s market longevity?
   Patent protections extend until at least 2030, creating a period of market exclusivity and revenue stability, barring generic equivalents.

3. What are the main competitors to STIOLTO RESPIMAT in the COPD market?
   Key competitors include Spiriva (Boehringer Ingelheim), Trelegy Ellipta (GSK), and other combination inhalers offering similar therapeutic benefits.

4. Which regions are expected to contribute most significantly to the growth of STIOLTO RESPIMAT?
   North America and Europe currently lead, but Asia-Pacific is poised for rapid growth due to high COPD prevalence and expanding healthcare access.

5. What are the potential risks facing STIOLTO RESPIMAT’s market expansion?
   Risks include price erosion from generics, regulatory hurdles, reimbursement constraints, and competitive product innovations.

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References

1. U.S. Food and Drug Administration. (2018). FDA approves STIOLTO RESPIMAT for COPD.
2. GOLD Report. (2022). Global Initiative for Chronic Obstructive Lung Disease.
3. Market Research Future. (2022). Inhaled COPD Therapy Market Analysis.
4. IMS Health. (2022). Pharmaceutical Sales Data.
5. NICE Guidelines. (2020). Management of COPD.
6. Real-World Evidence Study. (2021). Adherence and Outcomes with STIOLTO RESPIMAT.
7. PatentScope. (2022). Patent Landscape for Tiotropium/Olodaterol Formulations.
8. OECD. (2022). Pharmaceutical Pricing and Reimbursement Policies.

Note: All data are estimates and projections based on industry reports, market analysis, and publicly available sources.