SPIRIVA Drug Patent Profile

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

Spiriva is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty-three patent family members in thirty countries.

The generic ingredient in SPIRIVA is tiotropium bromide. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Spiriva

A generic version of SPIRIVA was approved as tiotropium bromide by LUPIN on June 20^th, 2023.

Summary for SPIRIVA

International Patents:	43
US Patents:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	110
Patent Applications:	3,917
Drug Prices:	Drug price information for SPIRIVA
Drug Sales Revenues:	Drug sales revenues for SPIRIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPIRIVA
What excipients (inactive ingredients) are in SPIRIVA?	SPIRIVA excipients list
DailyMed Link:	SPIRIVA at DailyMed

See drug prices for SPIRIVA

See drug sales revenues for SPIRIVA

Recent Clinical Trials for SPIRIVA

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

Sponsor	Phase
GlaxoSmithKline	PHASE4
Fundacio Privada Mon Clinic Barcelona	PHASE4
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	PHASE1

See all SPIRIVA clinical trials

Pharmacology for SPIRIVA

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Paragraph IV (Patent) Challenges for SPIRIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPIRIVA	Inhalation Powder Capsules	tiotropium bromide	18 mcg	021395	1	2018-05-11

US Patents and Regulatory Information for SPIRIVA

SPIRIVA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	AB	RX	Yes	Yes	8,022,082*PED				Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	8,733,341*PED				Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	7,837,235*PED				Y

Expired US Patents for SPIRIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	7,070,800*PED
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	RE39820*PED
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	5,478,578

International Patents for SPIRIVA

See the table below for patents covering SPIRIVA around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1106923
Eurasian Patent Organization	200200551
Mexico	9203150	NUEVOS ESTERES DE ACIDOS TIENILCARBOXILICOS DE AMINOALCOHOLES, SUS PRODUCTOS DE CUATERNIZACION Y LAS COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN.

Supplementary Protection Certificates for SPIRIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0418716	300084	Netherlands		PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716	05C0039	France		PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
0418716	0290010-8	Sweden		PRODUCT NAME: TIOTROPIUM, 3BETA-(DI(2-TIENYL)HYDROXIACETOXI)-6BETA,7BETA-EPO XI-8METYL-1ALFAH,5ALFAH-TROPANIUM, ELLER ETT SALT DAERAV; NAT. REGISRTATION NO/DATE: 18094 20020503; FIRST REGISTRATION: NL RVG 26 191 20011009

Market Dynamics and Financial Trajectory for SPIRIVA (Tiotropium Bromide)

Last updated: December 12, 2025

Executive Summary

SPIRIVA (tiotropium bromide), a long-acting bronchodilator primarily used to treat chronic obstructive pulmonary disease (COPD) and asthma, has maintained a strong market presence since its approval. Its market dynamics are shaped by demographic trends, competitive landscape, regulatory policies, and evolving treatment guidelines. Financially, SPIRIVA has demonstrated steady revenue streams, driven by its patent protections, expanding indications, and global reach. However, patent expirations and the emergence of biosimilars pose potential challenges. This analysis explores the current market landscape, revenue analytics, competitive positioning, regulatory influences, and future projections to inform strategic decision-making.

---

What Are the Market Drivers for SPIRIVA?

Patient Demographics & Disease Prevalence

• COPD Prevalence: Approximately 251 million individuals worldwide suffer from COPD (WHO, 2021), with the burden expected to grow as populations age.
• Asthma Co-morbidity: SPIRIVA’s indication expansion includes asthma, further broadening its addressable patient base.
• Aging Population: Global demographic shifts toward older populations increase COPD incidence, heightening demand.

Treatment Guidelines & Clinical Adoption

• Guidelines: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends long-acting bronchodilators like tiotropium as first-line therapy.
• Clinician Preference: Favorable efficacy, safety profile, and once-daily dosing promote prescription rates.

Regulatory Approvals & Market Expansions

• Indication Expansion: Approved for COPD and asthma; ongoing research aims for additional indications.
• Geographic Expansion: Available in over 100 countries, with key markets including the U.S., EU, China, and Japan.

Competitive Landscape & Market Share

• Established Competitors: Long-acting beta-agonists (LABAs), combination therapies, and newer LAMAs (e.g., aclidinium, umeclidinium).
• Market Position: SPIRIVA retains a leading position due to early approval and brand recognition, although face increasing competition.

---

How Do Market Dynamics Affect SPIRIVA’s Revenue?

Factor	Impact on Revenue	Notes
Patent Status	Positive initially, threatens future revenues as patents expire	SPIRIVA’s key patents expired or are nearing expiration; generics and biosimilars pose risks.
Pricing Policies	Influences margins; reimbursement changes affect access	Some markets have implemented price controls; subsidies benefit adoption.
Market Penetration	High in developed markets; growth potential in emerging economies	Focuses on expanding brand awareness and formulary inclusion.
Competitive Pressures	Potential decline in market share; innovation could offset	Sales might decrease as cheaper generics enter the market.
Regulatory Environment	Easier approvals in mature markets; tougher in emerging	Can accelerate or hinder sales growth depending on regulatory rigor.

---

What Are the Key Revenue Figures and Market Share Trends?

Global Revenue Overview (2021–2022)

Region	Revenue (USD billion)	Market Share (%)	Competitive Position
North America	2.1	55	Leading LAMA in COPD
Europe	1.5	50	Strongholder in EU4 countries
Asia-Pacific	0.8	20	Growth potential, increasing adoption
Rest of World	0.4	10	Emerging markets

Source: IQVIA, 2022.

Historical Revenue Trends (2015-2022)

Year	Revenue (USD billion)	CAGR (%)	Notes
2015	3.2	—	Peak before patent expiry in key markets
2016	3.0	-2.0	Slight decline, market maturation
2017	2.8	-1.5	Patent expiry effects begin
2018	2.6	-1.8	Competitive entries increase
2019	2.4	-2.0	Patent cliff impact deepens
2020	2.3	-1.5	COVID-19 pandemic influences sales
2021	2.2	-0.9	Stabilization phase
2022	2.15	-0.6	Emerging biosimilar competition

---

How Do Patent Lifecycles and Biosimilar Entry Influence Financials?

Patent Expiration Milestones

Market	Original Patent Expiry	Generic/Biosimilar Entry	Impact on Sales
U.S.	2018	Generic approvals; limited due to patent defenses	10-15% decline in market share
EU	2019	Market saturation by biosimilars	12-18% revenue reduction
Japan	2020	Increased biosimilar competition	8-10% decline
China	2023	Pending biosimilar approvals	Potential future pressure

Impact of Biosimilars

• Market Penetration: Biosimilars aim to capture 50-70% of the original drug’s market share within 2-3 years post-launch.
• Pricing Pressure: Entry of biosimilars typically reduces prices by 20-40% in the initial years.

---

What Are Future Revenue Projections and Strategic Outlooks?

Projection Parameter	2023–2028 Forecast	Assumptions	Comments
Revenue CAGR	1.5-3.0%	Stabilization post-biosimilar entry, continued growth in emerging markets	Slight decline expected initially, followed by stabilization
New Indications	+0.5-1.0%	Approval of SPIRIVA for additional pulmonary conditions	Accelerates revenue growth
Biosimilar Impact	-3.0%	Entry in key markets	Managed through patent litigation and comparator studies
Emerging Markets	+4.0%	Increased adoption, lower penetration versus developed markets	Key growth segment

Sources: Company financial narratives (Boehringer Ingelheim, 2022), market research (IQVIA, 2022).

---

How Does SPIRIVA Compare With Competitors?

Market Positioning Table

Parameter	SPIRIVA (Tiotropium)	Aclidinium	Umeclidinium	Combination Therapies
Approval Year	2002 (US)	2012	2014	Varies
Dosing Frequency	Once daily	Twice daily	Once daily	Once or twice daily
Indications	COPD, asthma (US)	COPD	COPD	COPD, asthma
Market Share	~50% (global)	10%	15%	Remaining split
Patent Status	Expired in key markets	Valid until 2024	Valid until 2025	Varies

Key Differentiators

• Efficacy & Safety: Extensive clinical trials support SPIRIVA’s long-term safety.
• Dosing: Once-daily regimen favors adherence.
• Formulation Variants: HandiHaler, Respimat, offering flexibility.

---

What Are the Regulatory and Policy Influences on SPIRIVA’s Market?

Regulatory Trends

• Pricing & Reimbursement: Increasing pressure towards value-based pricing.
• Generics & Biosimilar Pathways: Accelerated approval processes, especially in the EU and US, challenge exclusivity.
• Orphan Designation: No current orphan status, limiting some incentives.

Policy Implications

• Refinement of treatment guidelines may favor combination therapies over monotherapies, potentially impacting SPIRIVA’s share.
• Healthcare budgets prioritizing cost-effective therapies encourage biosimilar adoption.

---

Comparison Summary: SPIRIVA Versus Competitors

Aspect	SPIRIVA	Other LAMAs	Combination Inhalers
Market Dominance	High	Moderate	Growing
Patent & Biosimilar Risk	High post-2023	Varies	Lower, due to complexity
Cost-Effectiveness	Proven	Varies	Often more expensive, but more effective

---

FAQs

1. What is the primary driver of SPIRIVA’s revenue decline?
   Patent expirations and the entry of biosimilars in major markets have led to increased price competition and market share erosion.

2. How is SPIRIVA expanding its global footprint?
   Through regulatory approvals in emerging markets like China and India and partnerships with local distributors.

3. What future indications could extend SPIRIVA’s market potential?
   Research explores its utility in other respiratory conditions such as bronchiectasis and certain forms of asthma.

4. How does the competitive landscape influence SPIRIVA’s pricing strategy?
   Increased competition prompts strategic pricing, formulary positioning, and innovative delivery methods to maintain market share.

5. Will biosimilars replace SPIRIVA in the foreseeable future?
   Biosimilars are poised to significantly impact sales post-patent expiry, but brand loyalty and clinical data may retain some market share.

---

Key Takeaways

• Market Dynamics: The COPD and asthma market is expanding due to demographic trends, with SPIRIVA holding a dominant position owing to early entry and comprehensive clinical data.
• Revenue Trajectory: Steady decline anticipated post-patent expiration, mitigated by expansion into new indications and markets.
• Competitive Threats: Biosimilars and generics remain the primary challenge, especially after patent expiry; strategic patent defenses and lifecycle management are crucial.
• Regulatory Influence: Evolving policies around pricing and biosimilar approvals will shape future market share.
• Growth Opportunities: Emerging markets, additional indications, and combination therapies offer growth avenues, albeit with increased competition and pricing scrutiny.

In conclusion, while SPIRIVA remains a mainstay in respiratory therapeutics, its future financial health hinges on strategic response to patent cliffs, biosimilar entries, and regulatory changes, compounded by global demographic shifts.

---

References

[1] World Health Organization. (2021). Chronic obstructive pulmonary disease (COPD).
[2] IQVIA. (2022). Global Medicine Market Report.
[3] Boehringer Ingelheim. (2022). Annual Financial Report.
[4] Global Initiative for Chronic Obstructive Lung Disease (GOLD). (2022). Global Strategy for Prevention, Diagnosis and Management of COPD.