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.

The generic ingredient in STIOLTO RESPIMAT is olodaterol hydrochloride; tiotropium bromide. There is one drug master file entry for this compound. 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 six 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

US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	3
Patent Applications:	15
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
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
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015		RX	Yes	Yes	9,027,967		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

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	8,044,046
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	7,246,615
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	7,220,742

International Patents for STIOLTO RESPIMAT

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

Country	Patent Number	Title	Estimated Expiration
Argentina	003794	DISPOSITIVO MINIATURIZADO PARA PRESURIZAR UN FLUIDO, DISPOSITIVO DE BOMBA ALTERNADORA PARA PRODUCIR ALTA PRESION EN UN FLUIDO Y PULVERIZADOR DE UN FLUIDO
Austria	248028
Austria	352379
Australia	7287096
Australia	730797

Supplementary Protection Certificates for STIOLTO RESPIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	C300650	Netherlands		PRODUCT NAME: OLODATEROL, OPTISCHE ISOPMEREN; NAT. REGISTRATION NO/DATE: RVG 112058 20131023; FIRST REGISTRATION:
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	92433	Luxembourg		PRODUCT NAME: OLODATEROL,SES ISOMERES OPTIQUES INDIVIDUELS,MELANGES D ENANTIOMERES INDIVIDUELS OU DE RACEMATES,SES SELS D ADDITION D ACIDE AVEC DES ACIDES PHARMACEUTIQUEMENT ACCEPTABLES,AINSI QUE SES SOLVATES ET/OU SES HYDRATES,EN PARTICULIER L OLODATEROL ET LE CHLORHYDRATE D OLODATEROL
1562603	CR 2014 00014	Denmark		PRODUCT NAME: OLODATEROL, OPTISKE ISOMERER DERAF, BLANDINGER AF ISOMERER DERAF, SYREADDITIONSSALTE DERAF MED FARMAKOLGISK HARMLOESE SYRER, SAVEL SOM SOLVATER OG/ELLER HYDRATER DERAF, SAERLIGT OLODATEROL OG OLODATEROL HYDROCHLORID; NAT. REG. NO/DATE: 50975 20131014; FIRST REG. NO/DATE: MA 211/00401 20130918
1562603	C20140010 00101	Estonia		PRODUCT NAME: OLODATEROOL;REG NO/DATE: EE 825513 03.10.2013

STIOLTO RESPIMAT market dynamics and financial trajectory (tiotropium bromide/olodaterol)

Last updated: July 29, 2026

Executive summary: STIOLTO RESPIMAT (tiotropium bromide/olodaterol) is a chronic maintenance COPD inhaler that has delivered sustained global cash flow post-launch, supported by once-daily efficacy and broad guideline placement in Group B/E COPD (and escalating use in Group D through multiple-therapy pathways). Financial trajectory is tightly linked to (1) competitive intensity in long-acting muscarinic antagonist (LAMA) plus long-acting beta-2 agonist (LABA) combinations, (2) payer coverage and tender dynamics in Europe and Asia, (3) channel inventory control tied to Respiratory Syncytial Virus season adjacency but driven by COPD prescribing calendars, and (4) patent-and-exclusivity structure affecting the pace of generic entry and authorized brand competition. Revenue growth and margins are also constrained by inhaler device economics and manufacturing scale, with reported performance generally reflecting mix shift across regions and inhaler platform utilization.

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Market dynamics for STIOLTO RESPIMAT: why does tiotropium/olodaterol sell in COPD?

Direct driver: STIOLTO RESPIMAT is positioned as a fixed-dose LAMA/LABA regimen for COPD maintenance treatment, typically once daily via the RESPIMAT inhaler.

Demand mechanics that move the P&L

1. Guideline placement and step-up behavior. COPD care frequently escalates from monotherapy LAMA or LABA to dual therapy when symptoms persist or exacerbations continue. Fixed-dose combinations compress adherence friction compared with two separate inhalers.
2. Exacerbation risk management. Market adoption tends to increase when clinicians and payers associate dual bronchodilation with reduced exacerbations relative to monotherapy.
3. Inhaler switching costs. RESPIMAT adoption can persist due to patient familiarity, device training spend at clinics, and pharmacy substitution rules.
4. Payer formularies and prior authorization. Reimbursement policy shapes volume more than clinical differentiation once a class of dual bronchodilators is established.
5. Tenders in institutional markets. Competitive tendering (national and regional) drives price and share volatility in parts of Europe and emerging markets.

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How competitive is the LAMA/LABA class for STIOLTO RESPIMAT vs rivals?

Competitive set (class and substitution risk): STIOLTO competes against fixed-dose LAMA/LABA inhalers used for maintenance COPD, including other tiotropium-based combinations and alternative LAMA/LABA pairings.

Key competitive pressure points

• Price erosion through generics and authorized brand equivalents. Even when the molecules remain branded, competitor pricing can shift via authorized generics or branded-to-generic conversions elsewhere.
• Formulary “managed entry.” Payers often prefer 2 or 3 preferred LAMA/LABA options in a therapeutic class, pushing non-preferred brands into narrower use.
• Device platform differentiation. Inhaler device usability affects switching. RESPIMAT has a distinct mechanism and patient handling compared with dry powder inhalers (DPIs), which may be favored in some care settings for cold-chain-free logistics or patient preference.

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What does STIOLTO RESPIMAT’s regional market share and payer position imply for revenue growth?

Featured snippet answer: Revenue trajectory is most sensitive to (1) the speed of preferred formulary uptake in target markets and (2) tender-driven net price movements in institutional channels, rather than to patient volume alone.

Europe

• High tender intensity can cap net price even as underlying COPD prevalence rises.
• Volume growth tends to track policy stability and clinic conversion after initial RESPIMAT adoption.

United States

• Uptake is shaped by managed care coverage, pharmacy benefit design, and competitive response from other dual bronchodilators with strong rebate structures.
• Any class-level generic pressure is mediated by contract structure and formulary tiering.

Emerging markets

• Growth can be influenced by distribution maturity and affordability programs, but net price is often volatile with procurement cycles.

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When does STIOLTO RESPIMAT lose exclusivity, and how does that change financial outcomes?

Featured snippet answer: The pace and magnitude of exclusivity loss-driven pressure depends on patent-by-patent expiration timing, data exclusivity interactions, and whether legal challenges lead to early entry.

What matters financially

• Soft launch of authorized competitors vs. true generics. Authorized or label-aligned competitors often reduce price without fully collapsing volume.
• Paragraph IV and FDA timing in the US. If challengers file via the ANDA pathway for components or combination equivalency, entry timing can shift from purely patent-expiration calendars.
• Lifecycle management. Brand companies often respond with marketing intensity, line extensions, and contract renegotiations to defend net price.

(Note: specific exclusivity expiration dates and Paragraph IV timelines require Orange Book and patent register mapping for tiotropium/olodaterol combination products. That mapping is not included in the provided source set.)

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What is the Orange Book status of STIOLTO RESPIMAT, and how does it affect generic entry risk?

Featured snippet answer: Orange Book and associated patent listings dictate whether ANDA applicants face blocking patents at filing or eligibility to launch.

Generic entry risk channels

1. Blocking patents on the combination product. If claims cover the fixed-dose combination, generic approval may still be delayed.
2. Device or formulation-related patents. Even if API patents expire, device or formulation IP can limit product equivalence.
3. Method-of-use patents. If method-of-use claims remain in force, they can constrain label carve-outs and discourage immediate substitution.

(Note: Orange Book listings are not provided in the input dataset, so specific patent numbers and listed expiration dates are not enumerated.)

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How do formulation and device patents influence STIOLTO RESPIMAT’s commercialization economics?

Featured snippet answer: Inhaler-device and formulation IP can extend commercial control beyond API-level patents by limiting generic equivalence on performance, delivery, and user-actuation parameters.

Economic impact

• Manufacturing differentiation. Device engineering affects yield, assembly cost, and quality assurance spending.
• Stability and delivery performance. Drug product stability and aerosol performance requirements can raise the cost of generic development.
• Label equivalence requirements. If performance metrics diverge, developers may need additional bridging studies, pushing launch timing.

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What litigation and settlement history affects STIOLTO RESPIMAT launch timing for potential challengers?

Featured snippet answer: Settlement agreements can shift generic entry by calendar timing, altering net price trajectory and revenue run-rate.

Where it typically shows up in financials

• Pre-entry volume pull-forward. Brand demand can accelerate before entry dates.
• Post-entry net price compression. Even when volume holds temporarily, rebate and contracting often drive margin decline first.
• Share redistribution to authorized or “me-too” dual bronchodilators. Legal outcomes determine which competitor gets the first credible substitution position.

(Note: litigation docket details and settlement terms are not available in the provided dataset.)

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How do financial metrics typically evolve for STIOLTO RESPIMAT through the life cycle?

Life-cycle pattern for COPD inhalers

• Launch ramp (Year 0 to ~3): Growth driven by guideline adoption, clinic conversion, and payers moving the brand into preferred tiers.
• Maturity (mid-life): Volume growth slows; net revenue depends more on territory mix and contract rebates.
• Late-life defense: Margin protection becomes more important than share. Marketing expense, device cost reductions, and payer negotiations determine profitability more than incremental patient starts.
• Exclusivity pressure phase: Revenue trajectory becomes more “event-driven” around legal and regulatory milestones, with sharp net price effects.

Key financial line items sensitive to market dynamics

• Net product sales: Influenced by net price, mix, and patient persistence.
• Rebates and chargebacks: Increase when competing products force tier re-rating or higher rebates.
• Gross margin: Affected by device and inhaler manufacturing cost, plus lower net prices during tender cycles.
• Selling, general and administrative: COPD inhaler brands often maintain stable marketing spend, but intensity increases in competitive defense windows.

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How does STIOLTO RESPIMAT compare with competing dual bronchodilators on commercial risk?

Featured snippet answer: Commercial risk is highest when a competitor holds an earlier or stronger exclusivity position in a major payer segment, or when a cheaper inhaler with strong formulary placement gains share.

Risk ranking drivers

• Timing of patent expiry or legal resolution in key markets
• Strength of rebate and contract structures
• Device preference and adherence signals by clinician and patient populations
• Tender dominance by region

(Note: a quantified, competitor-by-competitor exclusivity and net price defense comparison requires patent estate and market access datasets not included in the provided material.)

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What generic entry scenarios are most likely to pressure STIOLTO RESPIMAT revenue?

Scenario set

1. First meaningful generic substitution occurs in the US. Typically produces rapid net price compression via pharmacy substitution and payer step-downs.
2. Parallel launch in Europe through national authorizations. Can cause regionally staggered declines as tenders re-run.
3. Authorized generic or permitted competition without full price collapse. Volume may remain partially protected; margin declines faster than sales.
4. Delayed generic entry due to blocking patents. Brand extends maturity with slower erosion.

(Note: the probability weights for each scenario require Orange Book and patent-by-patent event data.)

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Commercial trajectory implications for stakeholders: R&D, licensing, investment, and litigation

R&D

• The economic value of incremental COPD inhaler programs is higher where formulation/device or combination positioning extends defensibility.
• For next-gen bronchodilator combinations, the key is to secure payer-differentiated endpoints and a formulary story that withstands dual therapy class substitution.

Licensing

• Licensable value is highest when IP covers both performance-critical formulation/device characteristics and brand-relevant patient-use workflows.
• License negotiations should treat net price protection mechanisms (contracting, tender commitments, and payer education) as part of economic value, not just IP.

Litigation

• Where generic entry risk is driven by one or two pivotal patents, settlement leverage tends to concentrate around those claims.
• Case strategy should focus on the specific blocking claims that can prevent launch or restrict labeling.

Investment

• Revenue sensitivity is typically highest in windows where legal/regulatory milestones could change formulary status or substitution behavior.

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Key Takeaways

• STIOLTO RESPIMAT’s market dynamics are governed by COPD guideline step-up behavior to fixed-dose LAMA/LABA and by payer and tender mechanics that determine net price more than patient prevalence.
• Revenue trajectory is best understood as a function of regional net price, contract rebates, and device-driven switching friction, with major inflection risk at exclusivity and legal milestone windows.
• Patent and Orange Book status control generic substitution timing, which then drives margin compression and potential share shifts.
• Device and formulation IP can extend commercial control beyond simple API-level expiries by increasing generic development barriers and slowing equivalence approvals.

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FAQs

1. How do COPD formulary rules affect STIOLTO RESPIMAT net sales more than clinical differentiation?
2. What is the typical revenue impact when LAMA/LABA competitors gain preferred status in major payers?
3. How does tender pricing in Europe change profitability for inhaled COPD brands?
4. What factors most influence generic substitution speed for fixed-dose inhaled combinations?
5. How do inhaler device preferences influence patient switching and persistence in COPD?

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References

1. FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration.
2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of COPD.