STRIVERDI RESPIMAT Drug Patent Profile

Which patents cover Striverdi Respimat, and when can generic versions of Striverdi Respimat launch?

Striverdi Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There is one patent protecting this drug.

This drug has fifty-one patent family members in thirty-six countries.

The generic ingredient in STRIVERDI RESPIMAT is olodaterol hydrochloride. One supplier is listed for this compound. Additional details are available on the olodaterol hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Striverdi Respimat

Striverdi 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 STRIVERDI RESPIMAT

International Patents:	51
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	114
Drug Prices:	Drug price information for STRIVERDI RESPIMAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STRIVERDI RESPIMAT
What excipients (inactive ingredients) are in STRIVERDI RESPIMAT?	STRIVERDI RESPIMAT excipients list
DailyMed Link:	STRIVERDI RESPIMAT at DailyMed

See drug prices for STRIVERDI RESPIMAT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for STRIVERDI RESPIMAT

Constraining patent/regulatory exclusivity:

7,727,984

NDA:

203108

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 STRIVERDI RESPIMAT

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

Sponsor	Phase
Università degli Studi di Ferrara	Phase 4
Boehringer Ingelheim

See all STRIVERDI RESPIMAT clinical trials

Pharmacology for STRIVERDI RESPIMAT

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

US Patents and Regulatory Information for STRIVERDI RESPIMAT

STRIVERDI RESPIMAT is protected by one 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	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014		RX	Yes	Yes	7,727,984			Y

Expired US Patents for STRIVERDI RESPIMAT

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	7,491,719
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	7,220,742
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	7,056,916
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	7,786,111
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108-001	Jul 31, 2014	6,988,496

International Patents for STRIVERDI RESPIMAT

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1641569
Slovakia	89098	MECHANICAL COUNTER FOR A METERING APPARATUS
Yugoslavia	49347
Netherlands	300650
Germany	69334260
New Zealand	522221	Method for producing a container having a pressure compensation opening, and container produced according to said method
Hungary	226553	METHOD FOR PRODUCING A CONTAINER HAVING A PRESSURE COMPENSATION OPENING, AND CONTAINER PRODUCED ACCORDING TO SAID METHOD

Supplementary Protection Certificates for STRIVERDI RESPIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1562603	SPC/GB14/023	United Kingdom		PRODUCT NAME: OLODATEROL OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: MT MA 211/00401 20130918; UK PL 14598/0093 20131010
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	513	Finland
1562603	C300650	Netherlands		PRODUCT NAME: OLODATEROL, OPTISCHE ISOPMEREN; NAT. REGISTRATION NO/DATE: RVG 112058 20131023; FIRST REGISTRATION:
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	PA2014012,C1562603	Lithuania		PRODUCT NAME: OLODATEROLIS, JO OPTINIAI IZOMERAI, JO ATSKIRU ENANTIOMERU ARBA RACEMATU MISINIAI, JO RUGSTIES ADITYVINES DRUSKOS SU FRAMAKOLOGINIU POZIURIU PRIIMTINOMIS RUGSTIMIS, O TAIP PAT JO SOLVATAI IR/ARBA HIDRATAI, KONKRECIAI OLODATEROLIS IR OLODATEROLIO CHLORIDAS; NAT. REGISTRATION NO/DATE: LT/1/13/3429/001, LT/1/13/3429/002, LT/1/13/3429/003, LT/1/13/3429/004 20131031; FIRST REGISTRATION: 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 Striverdi Respimat

Last updated: February 20, 2026

What is the current market position of Striverdi Respimat?

Striverdi Respimat (generic name: olodaterol), developed by Boehringer Ingelheim, is a long-acting beta2-agonist (LABA) indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD). Launched in 2014 in the U.S. and Europe, it competes primarily with Tiotropium (Spiriva), Formoterol, and Salmeterol-based inhalers. The drug is positioned as a once-daily inhaler targeting moderate-to-severe COPD patients.

How does the drug perform within the COPD market?

Market Size and Penetration

• The COPD treatment market, valued at approximately $11 billion globally in 2022, is expected to reach $14 billion by 2028 at a CAGR of 4.1% (Data from IMV Market Research).
• Striverdi Respimat holds an estimated 10-12% share among LABA/long-acting muscarinic antagonist (LAMA) combination therapies, primarily in Europe and the U.S.
• The drug appeals to patients requiring once-daily dosing and those intolerant of other inhaler devices.

Distribution Channels

• Pharmacies account for over 75% of sales.
• Hospitals and specialty clinics constitute minor but growing channels, especially in severe COPD cases.
• Insurance formularies influence prescribing patterns, favoring drugs with proven efficacy and cost-effectiveness.

What are key drivers and barriers shaping the market?

Drivers

• Rising prevalence of COPD globally, projected to reach 200 million cases by 2040 (WHO).
• Increased awareness of inhalation therapy benefits.
• Growing adoption of inhaler devices with improved delivery mechanisms like Respimat, which offers better dose consistency and reduced user error.
• Boehringer Ingelheim's expanding geographic footprint, especially in emerging markets.

Barriers

• Competition from established brands: Tiotropium (Spiriva), which maintains around 55% market share among COPD therapies.
• Pricing pressures and formulary restrictions, particularly in countries with strong public healthcare controls.
• Limited differentiation: Striverdi Respimat's clinical benefits are comparable to other LABAs, exerting minimal pricing power.
• Patent protection expiry plans: No immediate patent cliffs reported but future exclusivity periods are finite (patent expiry expected in 2024-2025, barring extensions).

How do financials reflect the product's performance?

Revenue and Sales Growth

• In 2021, Striverdi Respimat generated approximately EUR 338 million (~USD 370 million), representing a year-over-year increase of roughly 4% (Boehringer Ingelheim Annual Report, 2021).
• The product’s CAGR from launch until 2022 has hovered around 5%, aligning with COPD market growth.

Cost Structure and Profitability

• Manufacturing costs are stable due to standardized inhaler production.
• Marketing expenses focus on physician education and patient adherence programs.
• Gross margins are estimated in low 70% range; net margins depend on R&D and marketing investments.

Future Revenue Trajectory

• Potential growth hinges on expanding indications, especially in asthma, and market penetration in emerging geographies.
• Launch of new formulations or combination therapies could cannibalize standalone Striverdi Respimat sales.
• Patent extensions could bolster exclusivity, while biosimilar or generic entrants pose risks post-expiration.

How is the broader market landscape evolving?

• The COPD market is increasingly oriented toward combination therapies—both inhaled corticosteroids (ICS) with LABAs and LAMAs with LABAs—diminishing standalone LABA market share.
• The rise of device innovation, including smart inhalers, seeks to improve adherence and outcomes, influencing device selection.
• Regulatory agencies have tightened approval criteria, emphasizing real-world evidence for inhaler efficacy and safety.

What regulatory and competitive developments are impacting the outlook?

• The U.S. FDA approval of generic versions of Spiriva in 2025 could pressure pricing for inhaled therapies like Striverdi Respimat.
• Boehringer Ingelheim actively seeks to extend indications and improve formulation delivery mechanisms.
• Competition from newer therapies, including bronchoscopic interventions and biologics for COPD, remains limited but could grow.

What strategic moves can influence future financial outcomes?

• Expanding into asthma indication could diversify revenue streams.
• Formulation innovations—like adding anti-inflammatory agents or fixed-dose combinations—may increase market share.
• Collaborations with payers to include Striverdi Respimat in preferred formularies could accelerate adoption.
• Geographic expansion into Asia-Pacific markets offers significant growth potential, with COPD prevalence rising.

Summary table of key data points

Metric	Details
Global COPD market size (2022)	$11 billion
Expected market size (2028)	$14 billion
Striverdi Respimat revenue (2021)	$370 million
Market share among LABA therapies	10-12%
Patent expiry expected	2024-2025
CAGR since launch (approximate)	5%

Key Takeaways

• Striverdi Respimat holds a steady position in the COPD sector, with moderate revenue growth aligned to overall disease prevalence.
• Competitive pressures from established therapies and emerging biosimilars pose challenges.
• The product's future hinges on geographic expansion, combination therapy development, and potential indication diversification.
• Pricing and formulary access are critical factors influencing financial trajectory.
• Strategic innovation and market access efforts can improve long-term profitability.

FAQs

What factors influence Striverdi Respimat’s market share?
Market share depends on prevalence of COPD, competitive offerings, device preference, formulary inclusion, and pricing strategies.

How does patent expiry affect future revenues?
Patent expiry around 2024-2025 may permit biosimilar entry, exerting downward pressure on prices and market share.

Are there new formulations or indications planned?
Current focus includes combination therapies and potential expansion into asthma; no confirmed new formulations announced.

What emerging markets present growth opportunities?
Asia-Pacific shows high potential due to rising COPD prevalence and expanding healthcare infrastructure.

How does device innovation influence sales?
Devices like Respimat offer dose accuracy and ease of use, supporting differentiated positioning and adherence.

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References

1. IMV Market Research. (2022). COPD treatment market analysis.
2. Boehringer Ingelheim. (2021). Annual report.
3. World Health Organization. (2022). COPD prevalence estimates.
4. U.S. Food and Drug Administration. (2023). Generic drug approvals.