OLODATEROL HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for olodaterol hydrochloride and what is the scope of freedom to operate?

Olodaterol hydrochloride is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olodaterol hydrochloride has seventy-six patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for OLODATEROL HYDROCHLORIDE

International Patents:	76
US Patents:	8
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	40
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLODATEROL HYDROCHLORIDE
DailyMed Link:	OLODATEROL HYDROCHLORIDE at DailyMed

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

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.

Recent Clinical Trials for OLODATEROL HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Boehringer Ingelheim	N/A
Yonsei University	N/A
Fraunhofer-Institute of Toxicology and Experimental Medicine	Phase 4

See all OLODATEROL HYDROCHLORIDE clinical trials

Pharmacology for OLODATEROL HYDROCHLORIDE

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for OLODATEROL HYDROCHLORIDE

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

US Patents and Regulatory Information for OLODATEROL HYDROCHLORIDE

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	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		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	7,837,235*PED				Y
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	7,727,984			Y
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		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	7,220,742		Y	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

Expired US Patents for OLODATEROL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	8,034,809
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	7,896,264
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	6,977,042
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	7,786,111
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	7,246,615
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	5,964,416
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	6,988,496

International Patents for OLODATEROL HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Ecuador	SP055774	NUEVO MEDICAMENTO PARA EL TRATAMIENTO DE LA ENFERMEDAD PULMONAR OBSTRUCTIVA CRÓNICA
New Zealand	551416	Preparation and uses of 6-hydroxy-8-{(R)-1-hydroxy-2-[2-(4-methoxy-phenyl)-1,1-dimethylethylamino]-ethyl}-4H-benzo[1,4]oxazin-3-one hydrochloride (Betamimetika)
Germany	10253282	Neue Arzneimittel zur Behandlung von chronisch obstruktiver Lungenerkrankung (Treatment of chronic obstructive pulmonary disease, using new or known N-substituted 2-amino-1-(benz-(1,4)-oxazin-3-on-8-yl)-ethanol derivative beta-mimetic agents, suitable for once-daily administration)
Peru	20040694	DERIVADOS DE BENZOXAZOLINONAS
European Patent Office	2025338	Nouveaux medicaments pour le traitement de la bronchopneumopathie obstructive chronique (New medicaments for the treatment of chronic ostructive pulmonary disease)
Australia	2003285326	NOVEL MEDICAMENTS FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASES
Portugal	1562603

Supplementary Protection Certificates for OLODATEROL HYDROCHLORIDE

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
1562603	21/2014	Austria		PRODUCT NAME: OLODATEROL, DESSEN SAEUREHAELTIGEN SALZE MIT PHARMAKOLOGISCH VERTRAEGLICHEN SAEUREN, IM BESONDEREN OLODATEROL HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 135232 20131125; FIRST REGISTRATION: MT MA211/00401 20130918
1562603	C 2014 025	Romania		PRODUCT NAME: OLODATEROL, IZOMERI OPTICI INDIVIDUALI AI ACESTUIA,AMESTECURI DE ENANTIOMERI INDIVIDUALI SAU RACEMATI, SARURILE DE ADITIE ACIDA ALE ACESTORA CU ACIZI ACCEPTABILIFARMACOLOGIC, CA SI SOLVATI SI/SAU HIDRATI AI ACESTORA, IN SPECIAL OLODATEROL SI CLORHI DRAT DE OLODATEROL -6-HIDROXI-2-{[1-(4-METOXIFENIL)-1,1-DIMETILETIL]AMINO}ETIL]-2H-1,4-BENZOXAZIN-3(4H)-ONA(CACLORHIDRAT); NATIONAL AUTHORISATION NUMBER: 6414/2014/01, 6414/2014/02, 6414/2014/03, 6414/2014/04; DATE OF NATIONAL AUTHORISATION: 20140507; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): MA211/00401; DATE OF FIRST AUTHORISATION IN EEA: 20130918

Market Dynamics and Financial Trajectory for Olodaterol Hydrochloride

Last updated: July 30, 2025

Introduction

Olodaterol hydrochloride, a long-acting beta2-agonist (LABA), has secured a niche within the therapeutic landscape for chronic obstructive pulmonary disease (COPD). Since its development, it has contributed to the expanding portfolio of inhaled bronchodilators, meeting the increasing global burden of COPD. As the pharmaceutical industry witnesses significant shifts driven by regulatory changes, technological innovations, and evolving healthcare demands, understanding the market dynamics and financial prospects of olodaterol hydrochloride is crucial for stakeholders navigating this competitive niche.

Pharmacological Profile and Therapeutic Position

Olodaterol hydrochloride is characterized by its once-daily dosing, high receptor selectivity, and favorable safety profile, distinguishing it from competing LABAs such as formoterol or salmeterol. Approved by the FDA and EMA primarily for COPD management, its pharmacokinetics offer rapid onset and sustained bronchodilation, promoting adherence and symptom control. Its therapeutic positioning complements long-acting muscarinic antagonists (LAMAs), often used in combination therapies, which are becoming the standard care for COPD.

Market Landscape and Competitive Environment

Global COPD Burden and Market Demand

COPD continues to rank among the leading causes of morbidity and mortality worldwide, affecting approximately 200 million individuals globally [[1]]. The rising prevalence, fueled by factors like aging populations, persistent smoking rates, and environmental pollutants, sustains demand for inhalation therapeutics, including olodaterol.

Market Players and Product Portfolio

Olodaterol's main competitors are other LABAs (salmeterol, formoterol, indacaterol) and fixed-dose combinations incorporating LABA and LAMA or ICS. Notably, the combination of olodaterol with tiotropium (Stiolto Respimat) represents a significant milestone, pairing olodaterol’s once-daily efficacy with the proven LAMA, tiotropium.

Regulatory and Patent Landscape

Initially introduced by Boehringer Ingelheim, olodaterol’s patent protections have offered exclusivity that supports profitable commercialization. However, patent expiration timelines are approaching, prompting generic interest and potential market erosion, especially in emerging markets where regulatory pathways are more accessible.

Market Dynamics Influencing Revenue and Growth

Innovation and Fixed-dose Combinations

The development of combination inhalers significantly influences olodaterol’s market trajectory. FDCs enhance convenience, adherence, and clinical outcomes, often commanding premium pricing. As such, the collaboration between Boehringer Ingelheim and pharmaceutical partners to expand olodaterol-based combinations will shape its growth prospects.

Pricing Strategies and Reimbursement Policies

Pricing remains a critical factor, especially in price-sensitive markets. Regulatory authorities and payers are increasingly demanding cost-effective therapies, pressuring pharmaceutical companies to justify premium prices with superior efficacy or safety. Reimbursement policies can either facilitate or hinder market penetration.

Emerging Markets and Expansion Opportunities

While mature markets like North America and Europe offer substantial revenue, their saturated nature and patent expirations restrict growth. Conversely, emerging economies present growth opportunities due to rising COPD prevalence and increasing healthcare spending, potentially offsetting Western market stagnation.

Technological Advancements

Innovations such as dry powder inhalers (DPIs), smart inhalers with dose-tracking capabilities, and personalized medicine approaches could redefine olodaterol’s market share, contingent on their clinical validation and acceptance.

Financial Trajectory and Revenue Forecasts

Historical Performance

Boehringer Ingelheim’s olodaterol franchise recorded revenues exceeding €500 million globally in the years following its launch, with steady growth driven by expanding indications and combination formulations (estimated figures based on financial reports, e.g., 2018-2020) [[2]]. Sales were predominantly concentrated in Europe and North America, with emerging markets contributing progressively.

Forecasted Growth Trends

Analysts project a compound annual growth rate (CAGR) of approximately 3-5% over the next five years for olodaterol, driven by:

• Expansion of fixed-dose combinations into routine treatment algorithms.
• Increased COPD diagnosis and awareness programs.
• Entry into new markets facilitated by regulatory approvals and strategic partnerships.

However, impending patent expiries and potential market saturation could temper growth projections. The shift towards personalized, combination therapies suggests that olodaterol, especially in innovatively delivered formulations, will sustain a moderate but stable revenue stream.

Impact of Patent Expirations and Biosimilar Entry

Patent expiry timelines (anticipated around 2023–2024) threaten exclusivity, paving the way for biosimilar manufacturers to introduce cost-competitive alternatives. The resultant price competition could erode margins unless olodaterol is repositioned within higher-priced combination inhalers or novel delivery systems.

Strategic Considerations for Stakeholders

• Portfolio Diversification: Extending olodaterol’s utility through combination therapies and exploring potential indications beyond COPD can mitigate patent cliffs.
• Market Access and Pricing: Engaging early with payers and regulators ensures favorable reimbursement pathways, especially in cost-sensitive regions.
• Innovation Investment: Prioritizing formulation improvements and digital health integrations could maintain competitive advantages.
• Geographical Expansion: Targeting emerging markets with tailored access strategies maximizes revenue potential.

Regulatory and Clinical Development Outlook

Future regulatory landscapes may favor more personalized inhalation therapies, requiring robust clinical evidence of olodaterol’s efficacy in diverse populations. Real-world evidence and comparative effectiveness studies will be pivotal in affirming its place alongside or within combination regimens.

Conclusion

Olodaterol hydrochloride occupies a significant segment within COPD management, with its market dynamics influenced by a confluence of clinical efficacy, formulation innovation, and competitive pressures. While current financial trajectories suggest moderate growth, strategic repositioning—through combination therapies, geographic expansion, and technological enhancement—remains essential to sustain and augment its market presence in a rapidly evolving therapeutic landscape.

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Key Takeaways

• Olodaterol’s unique pharmacological profile and once-daily dosing foster its competitiveness in COPD therapy, particularly in combination formulations.
• The approaching patent expiry presents both a challenge through potential biosimilar entry and an opportunity to refine product positioning.
• Expanding into emerging markets and leveraging technological innovations can drive sustained revenue growth.
• Price sensitivity and reimbursement policies critically impact market penetration, especially outside Western markets.
• Strategic investments in formulation, personalized medicine, and digital integration will be vital for maintaining market relevance.

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FAQs

1. What are the primary therapeutic advantages of olodaterol hydrochloride over other LABAs?
   Its once-daily dosing, high receptor selectivity, and favorable safety profile enhance adherence and reduce side effects, offering a competitive edge over some traditional LABAs.

2. How will patent expiration impact olodaterol's market share?
   Patent expiry may lead to biosimilar competition, exerting downward pressure on prices and margins. However, its integration into combination inhalers and expanding indications can offset declines.

3. In which regions is olodaterol likely to experience the highest growth?
   Emerging markets with rising COPD prevalence and growing healthcare infrastructure, such as Asia-Pacific and Latin America, present significant growth opportunities.

4. What role do combination therapies play in olodaterol’s future market strategy?
   Combining olodaterol with LAMAs or ICS enhances clinical outcomes, adherence, and allows premium pricing, making it a central pillar of its growth strategy.

5. What technological innovations could influence olodaterol’s market dynamics?
   Smart inhalers with dose-tracking, improved formulations such as dry powder inhalers, and personalized treatment approaches will bolster its clinical and commercial appeal.

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References

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for Prevention, Diagnosis, and Management of COPD. 2022.

2. Boehringer Ingelheim. Annual Financial Reports. 2018-2020.