OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE - Generic Drug Details

What are the generic drug sources for olodaterol hydrochloride; tiotropium bromide and what is the scope of patent protection?

Olodaterol hydrochloride; tiotropium bromide is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olodaterol hydrochloride; tiotropium bromide has one hundred and fifty-six patent family members in forty countries.

One supplier is listed for this compound.

Summary for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

International Patents:	156
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
DailyMed Link:	OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

Constraining patent/regulatory exclusivity:

7,727,984

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.

Pharmacology for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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	7,837,235*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	7,220,742		Y	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 OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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	8,034,809
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	6,977,042*PED
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	RE39820
Boehringer Ingelheim	STIOLTO RESPIMAT	olodaterol hydrochloride; tiotropium bromide	SPRAY, METERED;INHALATION	206756-001	May 21, 2015	7,786,111

International Patents for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0418364	dispositivo para a sustentação de um componente fluìdico
China	1678406	Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Eurasian Patent Organization	200500715	НОВЫЕ ЛЕКАРСТВЕННЫЕ СРЕДСТВА ДЛЯ ЛЕЧЕНИЯ ХРОНИЧЕСКОГО ОБСТРУКТИВНОГО ЗАБОЛЕВАНИЯ ЛЁГКИХ
Germany	502004005733
Austria	E380595

Supplementary Protection Certificates for OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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	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	C01562603/01	Switzerland		PRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014
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	300650	Netherlands		PRODUCT NAME: OLODATEROL, HET R-ENANTIOMEER DAARVAN, MENGSELS VAN ISOMEREN DAARVAN, ZUURADDITIEZOUTEN MET FARMACOLOGISCH AANVAARDBARE ZUREN DAARVAN, EVENALS SOLVATEN EN/OF HYDRATEN DAARVAN, IN HET BIJZONDER OLODATEROL EN OLODATEROLHYDROCHLORIDE; REGISTRATION NO/DATE: RVG 112058 20131023

Market Dynamics and Financial Trajectory for the Pharmaceutical Drugs: Olodaterol Hydrochloride and Tiotropium Bromide

Last updated: July 28, 2025

Introduction

In the contemporary respiratory therapeutics landscape, olodaterol hydrochloride and tiotropium bromide are pivotal bronchodilators used predominantly in managing chronic obstructive pulmonary disease (COPD) and asthma. Their evolving market dynamics—shaped by regulatory approval processes, clinical adoption, competitive landscape, and regional healthcare policies—have substantially affected their financial trajectories. This analysis delineates the core market drivers, challenges, and forecasts underpinning their future value propositions.

Market Overview

The global COPD drug market was valued at approximately USD 16 billion in 2022, with projected compounded annual growth rates (CAGR) approaching 4.9% through 2030 [1]. The demand fuel stems from aging populations, increased tobacco exposure, and rising awareness of respiratory diseases. Both olodaterol hydrochloride and tiotropium bromide occupy significant segments within long-acting bronchodilators (LABAs and LAMAs), respectively, with tiotropium historically leading the LAMA class.

Olodaterol Hydrochloride: Market Position and Dynamics

Product Profile and Regulatory Pathways

Olodaterol hydrochloride is a selective LABA providing long-lasting bronchodilation, typically administered via inhalation through devices like Respimat. Approved by the FDA in 2014 for COPD, its endorsement extended to asthma in some regions, contingent upon clinical data. The drug's positioning hinges on its once-daily dosing, high lung selectivity, and favorable safety profile.

Market Drivers

• Clinical Adoption and Label Updates: The FDA’s approval for COPD management amplified adoption, especially in combination therapies. The integration into fixed-dose combinations (FDCs) with other bronchodilators—such as tiotropium (LAMA) and glycopyrrolate—accelerated market penetration.

• Competitive Advantages: Olodaterol’s once-daily dosing enhances adherence, a critical parameter in COPD management, incentivizing clinicians to prescribe it over shorter-acting alternatives.

• Expanding Indications: Recent trials exploring its efficacy in asthma and high-risk COPD populations broaden its therapeutic scope, positioning it for sustained growth.

Market Challenges

• Competitive Landscape: Growing competition from other LABAs, like salmeterol, formoterol, and indacaterol, imposes pricing pressures. Additionally, newer agents with improved pharmacokinetic profiles are entering the market.

• Patent and Exclusivity Lifecycles: Patent expirations beginning post-2025 risk erosion of exclusivity, enabling generic competition that could reduce margins.

• Regional Variability: Regulatory hurdles in emerging markets slow access and reimbursement, constraining revenue growth.

Financial Trajectory

Olodaterol’s revenue flow is projected to grow steadily at a CAGR of approximately 3-5% until 2028, driven by increasing adoption in developed markets and strategic expansion via FDCs. Market penetration may be impeded by competitive substitution and patent cliffs, but lifecycle management—such as new formulations and combination therapies—provides mitigation pathways.

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Tiotropium Bromide: Market Position and Dynamics

Product Overview and Commercial Footprint

Tiotropium bromide, a LAMA introduced in the early 2000s, revolutionized COPD management with its long-acting profile and once-daily dosing. It was initially marketed as Spiriva and remains a cornerstone of pharmacotherapy, with global sales peaking near USD 2.5 billion in 2019 [2].

Market Dynamics

• Dominance and Market Share: Tiotropium retains a commanding share due to extensive clinical validation, Trust by physicians, and robust formulary coverage.

• Adjunct and Combination Use: Its extensive co-formulation with other agents, like olodaterol (Stiolto) and umeclidinium, enhances overall market adoption. These combinations are credited with improved adherence and symptom control.

• Regulatory Developments: Innovations such as hard capsules and soft inhalers continually improve patient usability, fostering sustained market presence.

Challenges Impacting Financial Performance

• Generic Entry and Price Erosion: Patent expiries in key markets (e.g., Europe in 2018) prompted generic entries, leading to significant price reductions and revenue diminution.

• Emerging Alternatives: The advent of inhalers with better delivery systems and formulations, including triple therapy options, diversifies the therapeutic landscape.

• Reimbursement and Access Policies: Variations in healthcare coverage impact sales in emerging markets, requiring tailored market strategies.

Projected Financial Outlook

While the base revenue remains substantial, a decline of approximately 4-6% annually is expected in developed markets post-patent expiration, unless offset by new combination therapies or indications. However, in regions where generics face delayed approval, revenues may stabilize longer-term. The expansion into emerging markets presents a growth opportunity but with inherent challenges.

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Market Synergies and Growth Opportunities

Combination Therapy Expansion

The synergistic use of olodaterol and tiotropium in fixed-dose formulations addresses unmet needs in COPD management by optimizing bronchodilation and reducing exacerbations. The ongoing development and commercialization of such FDCs are critical to capturing larger market shares and counteracting generic competition.

Personalized Medicine and Biomarkers

Advances in pharmacogenomics and diagnostic testing are enabling targeted therapy, which may refine drug utilization patterns. Incorporating predictive markers improves efficacy assessments, potentially driving increased prescription volumes.

Regulatory and Policy Trends

Stringent regulatory standards, especially in the European Union and North America, emphasize product safety and efficacy, influencing market entry strategies. Healthcare systems prioritizing cost-effective treatments may favor generic uptake, constraining branded drug revenues but also stimulating innovation in proprietary delivery systems.

Regional Market Dynamics

Emerging markets, including China and India, are witnessing accelerated growth in respiratory disease prevalence. Local manufacturers’ entry and patent challenges create avenues for market expansion, provided reimbursement frameworks evolve accordingly.

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Conclusion

Olodaterol hydrochloride and tiotropium bromide are integral components of COPD therapy, with their market dynamics intricately tied to regulatory environments, clinical acceptance, competitive forces, and regional healthcare policies. While tiotropium remains a market leader, poised to decline modestly post-genericization, olodaterol's growth prospects hinge on strategic combination formulations and expanding indications. Both drugs’ financial trajectories will be shaped by innovation, patent management, and regional market penetration strategies.

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Key Takeaways

• The respiratory therapeutics market for olodaterol and tiotropium is characterized by steady growth, with strategic expansion via combination therapies being pivotal.

• Patent expirations threaten revenue streams but open opportunities for generics and biosimilars; innovation in delivery systems and formulations remains essential to sustain market relevance.

• Regional healthcare policies and reimbursement strategies significantly influence sales trajectories, particularly in emerging markets.

• Personalized medicine components and patient adherence initiatives are key to optimizing therapeutic outcomes and fostering market expansion.

• Competitive pressures necessitate continuous lifecycle management, including developing next-generation formulations, novel indications, and combination treatments.

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FAQs

Q1: How will patent expirations influence the sales of tiotropium bromide?

A1: Patent expirations, particularly in Europe and the U.S., have led to the entry of generic versions, substantially reducing prices and margins. While initial sales decline is expected, branded formulations can sustain revenue through improved formulations and combination therapies.

Q2: What role do fixed-dose combinations play in the future market trajectory of olodaterol?

A2: FDCs combining olodaterol with other bronchodilators improve patient adherence, enhance efficacy, and expand therapeutic indications, serving as a growth driver and counterbalance to generic competition.

Q3: Are there regulatory hurdles affecting the global adoption of these drugs?

A3: Yes. Approvals depend on regional regulatory agencies’ standards, with some markets requiring additional clinical data or localized formulation testing, affecting speed and cost of market entry.

Q4: What emerging markets present significant growth opportunities for these drugs?

A4: Countries like China, India, and Brazil offer expanding COPD prevalence, with improving healthcare infrastructure and rising awareness, creating substantial growth potential for both drugs.

Q5: How does clinical evidence impact market competitiveness for olodaterol and tiotropium?

A5: Strong clinical data supporting efficacy and safety bolster prescribing confidence, facilitate formulary inclusion, and influence regulatory approvals, directly impacting sales and market share.

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References

[1] MarketWatch, "Global COPD Drugs Market Size, Share & Trends Analysis Report," 2023.

[2] IQVIA, "Global Sales Data for Tiotropium Bromide," 2022.