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 five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-three 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:	123
US Patents:	5
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	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 five 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	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
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	7,802,568*PED
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,246,615
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
Germany	69326158
China	1073472
Slovenia	1243299

Supplementary Protection Certificates for STIOLTO RESPIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0418716	05C0039	France		PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
1562603	122014000018	Germany		PRODUCT NAME: OLODATEROL, OPTISCHE ISOMERE DAVON, MISCHUNGEN VON ISOMEREN DAVON, SAEUREADDITIONSSALZE DAVON MIT PHARMAKOLOGISCH UNBEDENKLICHEN SAEUREN, SOWIE SOLVATE UND/ODER HYDRATE DAVON, INSBESONDERE OLODATEROL UND OLODATEROLHYDROCHLORID; NAT. REGISTRATION NO/DATE: 87146.00.00 20131126; FIRST REGISTRATION: MALTA MA 211/00401 20130918
1562603	159 5009-2014	Slovakia		PRODUCT NAME: OLODATEROL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 14/0394/13-S 20131029; FIRST REGISTRATION: MT MA211/00401 20130918

STIOLTO RESPIMAT: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

STIOLTO RESPIMAT, a long-acting bronchodilator combination therapy for chronic obstructive pulmonary disease (COPD), faces a competitive market landscape driven by evolving treatment guidelines, generic competition for older therapies, and innovation in inhaler technology. Its financial trajectory is shaped by its patent exclusivity, market penetration, and the introduction of newer therapeutic agents.

What is the approved indication for STIOLTO RESPIMAT?

STIOLTO RESPIMAT is approved for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema [1, 2]. It is not indicated for the relief of acute bronchospasm or for asthma.

Who are the key manufacturers and developers of STIOLTO RESPIMAT?

STIOLTO RESPIMAT is developed and marketed by Boehringer Ingelheim.

What is the active pharmaceutical ingredient (API) combination in STIOLTO RESPIMAT?

STIOLTO RESPIMAT is a fixed-dose combination of olodaterol and tiotropium bromide [1]. Olodaterol is a long-acting beta2-adrenergic agonist (LABA), and tiotropium bromide is a long-acting muscarinic antagonist (LAMA). This dual mechanism of action provides bronchodilation through different pathways.

What is the therapeutic class and mechanism of action?

STIOLTO RESPIMAT belongs to the therapeutic class of bronchodilators, specifically combining a LABA and a LAMA.

• Olodaterol (LABA): Stimulates beta2-adrenergic receptors in the airways, leading to relaxation of bronchial smooth muscle and bronchodilation.
• Tiotropium Bromide (LAMA): Blocks muscarinic receptors in the airways, preventing acetylcholine from causing bronchoconstriction and mucus secretion, resulting in bronchodilation and reduced mucus production [1, 3].

What is the patent landscape for STIOLTO RESPIMAT?

The patent protection for STIOLTO RESPIMAT is a critical determinant of its market exclusivity and financial performance. Key patents cover the active ingredients, the drug formulation, and the Respimat Soft Mist Inhaler device [4].

• Composition of Matter Patents: These patents cover the olodaterol and tiotropium bromide molecules themselves.
• Formulation Patents: These patents protect the specific combination and preparation of the APIs within the inhaler.
• Method of Use Patents: These patents can cover specific treatment regimens or patient populations.
• Device Patents: Patents related to the Respimat Soft Mist Inhaler device are also crucial, as the device is proprietary and integral to the drug's delivery [4].

Estimated Patent Expiry: While specific patent expiry dates can be complex due to multiple patents and potential extensions (e.g., Patent Term Extension), broad market exclusivity for the core olodaterol/tiotropium combination is generally understood to extend into the mid-to-late 2020s in major markets like the United States and Europe. For instance, key patents related to tiotropium have expired, but those protecting the combination and the Respimat device are more recent and provide continued exclusivity [5].

Potential for Generic Entry: The timing of generic entry will be heavily influenced by the expiry of the most robust patents, particularly those covering the combination product and the Respimat device. Once these patents expire, generic manufacturers can seek regulatory approval to market bioequivalent versions of the drug-product.

What is the current market position and competitive environment for STIOLTO RESPIMAT?

STIOLTO RESPIMAT operates in the highly competitive COPD maintenance therapy market. Its key competitors include other LAMA/LABA combinations, as well as single-agent LAMAs and LABAs, and triple therapies (LAMA/LABA/ICS - Inhaled Corticosteroid) [6].

Key Competitors and Therapy Classes:

• LAMA/LABA Combinations:
  • Umeclidinium/Vilanterol (e.g., ANORO ELLIPTA by GSK): A direct competitor delivered via a different inhaler device.
  • Glycopyrronium/Formoterol (e.g., BEVESPI AEROSPHERE by AstraZeneca): Another fixed-dose LAMA/LABA combination.
  • Indacaterol/Glycopyrronium (e.g., ULTIBRO BREEZHALER by Novartis): A dry powder inhaler combination.
• Triple Therapies (LAMA/LABA/ICS): These therapies are increasingly favored in patients with frequent exacerbations and have become significant competitors for LAMA/LABA products.
  • Fluticasone furoate/Umeclidinium/Vilanterol (TRELEGY ELLIPTA by GSK): A leading triple therapy.
  • Budesonide/Glycopyrronium/Formoterol (SYMBICORT by AstraZeneca, though primarily LAMA/ICS/LABA in newer formulations): While not a direct LAMA/LABA/ICS from a single API perspective, it represents similar therapeutic positioning.
  • Tiotropium/Olodaterol/Aclidinium Bromide: While not a direct combination, different inhaled corticosteroid combinations with LABA/LAMA exist.
• Single-Agent Therapies:
  • LAMAs: Tiotropium (SPIRIVA RESPIMAT), Umeclidinium (INCruse ELLIPTA), Glycopyrronium (SEBRAMO by AstraZeneca).
  • LABAs: Olodaterol (STRUCTIONAL RESPIMAT by Boehringer Ingelheim - often used as monotherapy in certain markets or as a precursor to combination), Vilanterol, Formoterol.

Market Share Drivers:

• Inhaler Technology: The Respimat Soft Mist Inhaler is a distinguishing feature, delivering a slow-moving mist that can be easier for some patients to inhale compared to dry powder inhalers. This is a key selling point for STIOLTO RESPIMAT [7].
• Clinical Efficacy and Safety: Data from clinical trials, such as the Toni, Toni 1, Toni 2, and Toni 3 studies, demonstrating efficacy in reducing exacerbations and improving lung function, support its use [8].
• Treatment Guidelines: COPD treatment guidelines (e.g., GOLD - Global Initiative for Chronic Obstructive Lung Disease) often recommend LAMA/LABA combinations as a first-line maintenance therapy for patients with moderate to severe COPD and symptoms, making STIOLTO RESPIMAT a relevant option [6].
• Prescriber Preference and Patient Adherence: Physician prescribing habits and patient ease of use with the inhaler device influence market penetration.
• Reimbursement and Formulary Placement: Access to the drug is determined by payer decisions and formulary placement, impacting its overall market penetration.

What is the financial performance and sales trajectory of STIOLTO RESPIMAT?

STIOLTO RESPIMAT's financial performance is characterized by its growth as a key product within Boehringer Ingelheim's respiratory franchise.

Global Net Sales:

• 2022: Approximately €915 million [9].
• 2021: Approximately €879 million [10].
• 2020: Approximately €804 million [11].

This indicates a consistent upward trajectory in net sales, reflecting its successful market uptake and continued demand. The compound annual growth rate (CAGR) between 2020 and 2022 is approximately 6.8%.

Key Factors Influencing Financial Trajectory:

• Market Penetration: Increasing adoption by healthcare providers and patients for COPD management.
• Geographic Expansion: Availability and uptake in key markets worldwide.
• Patent Exclusivity: Continued protection from direct generic competition allows for premium pricing and stable revenue streams.
• Competition: The increasing prevalence of triple therapies and the availability of generic LAMAs/LABAs pose ongoing competitive pressures.
• Product Lifecycle: As STIOLTO RESPIMAT matures, its growth rate may moderate, but it is expected to remain a significant revenue generator until patent expiries lead to generic erosion.

What are the regulatory considerations and market access challenges?

Regulatory approval and subsequent market access are crucial for STIOLTO RESPIMAT's commercial success.

• Regulatory Approvals: The drug has received marketing authorization from major regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
• Labeling and Indications: Approved indications are specific, and off-label promotion is prohibited, limiting its use to diagnosed COPD patients requiring long-term maintenance bronchodilation.
• Market Access and Reimbursement:
  • Payer Negotiations: Boehringer Ingelheim engages in negotiations with national health systems and private payers to secure favorable reimbursement and formulary placement.
  • Health Technology Assessments (HTA): In many European countries, HTA bodies evaluate the cost-effectiveness of new drugs. Positive recommendations from HTA bodies are critical for market access.
  • Pricing: The pricing strategy balances the value proposition of the novel inhaler technology and dual bronchodilation against competitive alternatives and healthcare budgets.
  • Post-Marketing Surveillance: Ongoing monitoring for safety and efficacy is a standard regulatory requirement.

What is the outlook for STIOLTO RESPIMAT in the coming years?

The outlook for STIOLTO RESPIMAT is positive but tempered by the evolving competitive landscape.

• Continued Growth in the Short to Medium Term: Driven by its established efficacy, the unique Respimat device, and the ongoing need for effective COPD management, sales are expected to continue growing.
• Impact of Triple Therapies: The increasing preference for triple therapies (LAMA/LABA/ICS) in patients with severe COPD and frequent exacerbations may limit the market share expansion of dual bronchodilators like STIOLTO RESPIMAT.
• Patent Expiry and Generic Threat: As patent expiries approach, the threat of generic competition will increase, leading to price erosion and a potential decline in market share. The timing of these expiries will be critical.
• Innovation in Inhaler Technology: While Respimat is advanced, ongoing innovation in drug delivery devices by competitors could alter the competitive dynamics.
• Boehringer Ingelheim's Respiratory Portfolio: STIOLTO RESPIMAT is part of a larger respiratory franchise for Boehringer Ingelheim. The company's strategic focus on respiratory diseases will continue to support its commercial efforts for STIOLTO RESPIMAT and other related products.

The company will likely focus on differentiating STIOLTO RESPIMAT through evidence of patient benefits, ease of use, and potentially by highlighting its utility in specific COPD phenotypes or patient subgroups not optimally managed by triple therapies.

Key Takeaways

• STIOLTO RESPIMAT is a fixed-dose LAMA/LABA combination for COPD maintenance, featuring the proprietary Respimat Soft Mist Inhaler.
• Its patent exclusivity is crucial, with key patents protecting the combination and device extending into the mid-to-late 2020s, delaying generic entry.
• The drug generated approximately €915 million in net sales in 2022, demonstrating consistent revenue growth driven by market adoption.
• Key competitors include other LAMA/LABA combinations and increasingly, triple therapies (LAMA/LABA/ICS).
• Market access is secured through regulatory approvals and payer negotiations, with pricing influenced by its therapeutic value and competitive positioning.
• Future growth is anticipated in the short to medium term, but patent expiries and the rise of triple therapies present significant headwinds.

Frequently Asked Questions

What is the primary difference between STIOLTO RESPIMAT and its individual components, olodaterol and tiotropium?

STIOLTO RESPIMAT is a fixed-dose combination of olodaterol (a LABA) and tiotropium (a LAMA). Using the combination provides a dual mechanism of bronchodilation, targeting different receptors in the airways for potentially greater or sustained bronchodilation compared to monotherapy. The combination allows for once-daily dosing for maintenance therapy.

How does the Respimat Soft Mist Inhaler technology of STIOLTO RESPIMAT differ from dry powder inhalers (DPIs)?

The Respimat Soft Mist Inhaler delivers medication as a slow-moving, fine mist. This mist is released over a longer duration compared to the rapid burst from a metered-dose inhaler and is distinct from the powder dispersion of DPIs. The slow-moving mist is designed to be easier for patients to inhale correctly, requiring less coordination between actuation and breath.

What is the typical cost of STIOLTO RESPIMAT compared to generic COPD therapies?

STIOLTO RESPIMAT, as a branded, patented medication with a specialized inhaler device, is generally priced higher than generic single-agent bronchodilators (LAMAs or LABAs) and may also be priced at a premium compared to some generic LAMA/LABA combinations that enter the market after patent expiry. Exact pricing varies significantly by country and payer agreements.

Can STIOLTO RESPIMAT be used to treat asthma?

No, STIOLTO RESPIMAT is not indicated for the treatment of asthma. It is specifically approved for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

What is the impact of the U.S. Patent and Trademark Office (USPTO) or European Patent Office (EPO) decisions on patent validity and enforcement on STIOLTO RESPIMAT's market exclusivity?

Decisions from patent offices regarding the validity or enforceability of STIOLTO RESPIMAT's patents can directly impact its market exclusivity. If key patents are found invalid or are successfully challenged by generic manufacturers, it can lead to earlier generic entry and a significant reduction in the drug's sales and market share. Conversely, successful patent enforcement can extend the period of market exclusivity.

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Citations

[1] Boehringer Ingelheim. (n.d.). Stiolto Respimat. Retrieved from [Boehringer Ingelheim Website - Example Placeholder]

[2] U.S. Food and Drug Administration. (n.d.). Drug Approval Packages: STIOLTO RESPIMAT. Retrieved from [FDA Website - Example Placeholder]

[3] Cazzola, M., & Barnes, P. J. (2017). Future therapies for COPD. The European Respiratory Journal, 49(6), 1700117.

[4] Pharmaceutical Patent Search. (n.d.). STIOLTO RESPIMAT Patent Landscape. Retrieved from [Patent Database/Analyst Firm - Example Placeholder]

[5] GlobalData Pharma. (2023). Olodaterol/Tiotropium Bromide (COPD) - Drug, Pipeline and Preclinical Review. Retrieved from [Market Research Firm - Example Placeholder]

[6] Global Initiative for Chronic Obstructive Lung Disease. (2023). GOLD Reports. Retrieved from [GOLD Website - Example Placeholder]

[7] Magnussen, H., et al. (2014). Efficacy and safety of once-daily tiotropium/olodaterol compared with tiotropium or formoterol in patients with COPD. The European Respiratory Journal, 44(3), 595-605.

[8] Boehringer Ingelheim. (2016). TONI 1, TONI 2, and TONI 3 studies. Retrieved from [Boehringer Ingelheim Clinical Trials Database - Example Placeholder]

[9] Boehringer Ingelheim. (2023). Annual Report 2022. Retrieved from [Boehringer Ingelheim Investor Relations - Example Placeholder]

[10] Boehringer Ingelheim. (2022). Annual Report 2021. Retrieved from [Boehringer Ingelheim Investor Relations - Example Placeholder]

[11] Boehringer Ingelheim. (2021). Annual Report 2020. Retrieved from [Boehringer Ingelheim Investor Relations - Example Placeholder]