Olodaterol hydrochloride - Generic Drug Details

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

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

Olodaterol hydrochloride has fifty-one patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for olodaterol hydrochloride

International Patents:	51
US Patents:	5
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	7,396,341*PED				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	8,733,341		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
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	7,727,984			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	7,802,568
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	7,104,470
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	7,284,474
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	7,896,264

International Patents for olodaterol hydrochloride

Country	Patent Number	Title	Estimated Expiration
Malaysia	136034	NEW MEDICAMENTS FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Taiwan	I343812
Netherlands	300650
Canada	2506082	NOUVEAUX MEDICAMENTS DESTINES AU TRAITEMENT DE LA BRONCHOPNEUMOPATHIE CHRONIQUE OBSTRUCTIVE (NOVEL MEDICAMENTS FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASES)
Spain	2326878
World Intellectual Property Organization (WIPO)	2004045618

Supplementary Protection Certificates for olodaterol hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	C01562603/01	Switzerland		PRODUCT NAME: OLODATEROL; REGISTRATION NO/DATE: SWISSMEDIC 62880 12.05.2014
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	513	Finland
1562603	C20140010 00101	Estonia		PRODUCT NAME: OLODATEROOL;REG NO/DATE: EE 825513 03.10.2013
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	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

Olodaterol hydrochloride Market Analysis and Financial Projection

Last updated: February 15, 2026

Market Dynamics and Financial Trajectory for Olodaterol Hydrochloride

Overview of Olodaterol Hydrochloride

Olodaterol hydrochloride is a long-acting beta-agonist (LABA) indicated primarily for maintenance treatment of chronic obstructive pulmonary disease (COPD). It is marketed under the brand name Striverdi Respimat by Boehringer Ingelheim. Approved by the FDA in 2014, it offers twice-daily dosing and has demonstrated efficacy in improving lung function and reducing exacerbations.

Market Penetration and Competitive Landscape

Current Market Position

• As of 2023, olodaterol remains a niche within the broader COPD management market.
• Its primary competitors include indacaterol, formoterol, and vilanterol.
• Olodaterol's global sales were estimated at approximately $300 million in 2022 (source: IQVIA), with steady growth projected.

Geographic Distribution

• Dominates in Europe, where it benefits from established healthcare procurement.
• Its presence in the U.S. market is contingent on formulary placements, influenced by competitive offerings and contract negotiations.
• Growing adoption in Asian markets, especially Japan and China, driven by expanding COPD prevalence.

Regulatory Developments

• Regulatory flexibility, such as orphan drug designation for specific subpopulations in some regions, can influence market access.
• Pending or recent approvals of combination products with long-acting muscarinic antagonists (LAMAs) could expand its clinical utility, affecting overall sales.

Market Drivers and Restraints

Drivers

• Rising COPD prevalence globally, estimated at 210 million cases (WHO, 2021).
• Increased adoption of inhaled long-acting bronchodilators as standard care.
• Favorable dosing profile (twice daily) relative to some competitors.

Restraints

• Competition from newer, once-daily LABAs like indacaterol and vilanterol.
• Patent expirations; Boehringer Ingelheim's patent on Striverdi Respimat expired in most territories between 2020 and 2022, opening generic and OTC options.
• Cost and formulary constraints limiting access in some healthcare systems.

Financial Trajectory

Revenue Outlook

• Short-term growth (2023-2025): Expected to stabilize or slightly decline as competition intensifies.
• Long-term growth (2026-2030): Potential increase if combination therapies featuring olodaterol gain approval, such as with glycopyrrolate or umeclidinium.

Year	Estimated Sales (USD millions)	Growth Rate
2022	300	—
2023	280–310	-3% to +3%
2024	290–330	+3% to +6%
2025	300–350	+3% to +6%
2026	330–400	+4% to +14%

Note: These projections incorporate market competition, patent status, and regulatory extensions.

Investment and R&D Outlook

• Boehringer Ingelheim continues research into fixed-dose combinations that include olodaterol.
• Potential pipeline candidates include once-daily formulations and formulations with enhanced pulmonary delivery.
• R&D investments are moderate, focusing on improving patient adherence and expanding indications.

Key Market Challenges

• Patent cliffs create pressure on pricing.
• Competition from generic formulations reduces margins.
• The advent of triple therapy inhalers (e.g., ICS/LABA/LAMA combinations) offers alternatives that may diminish olodaterol's market share.

Strategic Considerations

• Formulation enhancements and new combination products could revive growth.
• Partnering with generic manufacturers or engaging in licensing agreements could mitigate revenue declines post-patent expiry.
• Market expansion into emerging economies requires tailored pricing strategies and local regulatory navigation.

Key Takeaways

• Olodaterol hydrochloride's current market share is modest but stable, supported by existing COPD treatment protocols.
• Competition and patent expiry present significant risks to revenue.
• Future growth hinges on the success of combination therapies and pipeline development.

FAQs

1. What is the primary clinical advantage of olodaterol hydrochloride?
   Its twice-daily dosing offers sustained bronchodilation, improving lung function in COPD patients.

2. How does olodaterol compare to competitors in terms of efficacy?
   Clinical trials show comparable efficacy to other LABAs like indacaterol, with differences mainly in dosing and side-effect profiles.

3. What are the implications of patent expiry on olodaterol sales?
   Patent expiry in several regions lowered barriers for generic competition, potentially reducing brand-name sales and encouraging price competition.

4. Are new formulations or combinations expected to impact the market significantly?
   Yes. Fixed-dose combinations with LAMAs or inhaled corticosteroids (ICS) are likely to attract more prescribers and expand the market.

5. What is the opportunity in emerging markets?
   Growing COPD prevalence and unmet needs present an opportunity, provided companies can navigate local regulations and price sensitivities.

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References

1. IQVIA. "Global Respiratory Market Reports 2022."
2. World Health Organization. "Chronic Obstructive Pulmonary Disease (COPD): Factsheet." 2021.