DUAKLIR PRESSAIR Drug Patent Profile

Which patents cover Duaklir Pressair, and what generic alternatives are available?

Duaklir Pressair is a drug marketed by Covis and is included in one NDA. There are two patents protecting this drug.

This drug has seventy-two patent family members in thirty-six countries.

The generic ingredient in DUAKLIR PRESSAIR is aclidinium bromide; formoterol fumarate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the aclidinium bromide; formoterol fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Duaklir Pressair

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 13, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DUAKLIR PRESSAIR

International Patents:	72
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for DUAKLIR PRESSAIR
What excipients (inactive ingredients) are in DUAKLIR PRESSAIR?	DUAKLIR PRESSAIR excipients list
DailyMed Link:	DUAKLIR PRESSAIR at DailyMed

See drug prices for DUAKLIR PRESSAIR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DUAKLIR PRESSAIR

NDA:

210595

Dosage:

POWDER, 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 DUAKLIR PRESSAIR

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

US Patents and Regulatory Information for DUAKLIR PRESSAIR

DUAKLIR PRESSAIR is protected by two US patents.

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
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y

Expired US Patents for DUAKLIR PRESSAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019

International Patents for DUAKLIR PRESSAIR

When does loss-of-exclusivity occur for DUAKLIR PRESSAIR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Peru

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DUAKLIR PRESSAIR around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	73509	ХИНУКЛИДИНОВЫЕ ПРОИЗВОДНЫЕ И ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ ЛИГАНДОВ МУСКАРИНОВОГО М3-РЕЦЕПТОРА;ХІНУКЛІДИНОВІ ПОХІДНІ ТА ЇХ ВИКОРИСТАННЯ ЯК ЛІГАНДІВ МУСКАРИНОВОГО М3-РЕЦЕПТОРА (QUINUCLIDINE DERIVATIVES AND USE THEREOF AS LIGANDS OF MUSCARINIC М3-RECEPTOR)
European Patent Office	1200431	DERIVES DE QUINUCLIDINE ET LEUR UTILISATION COMME LIGANDS DES RECEPTEURS M3 MUSCARINIQUES (QUINUCLIDINE DERIVATIVES AND THEIR USE AS MUSCARINIC M3 RECEPTORS LIGANDS)
Russian Federation	2007105156	ИНГАЛЯТОР И КАРТРИДЖ ДЛЯ ЛЕКАРСТВЕННОГО ПОРОШКОВОГО ПРЕПАРАТА И СПОСОБ ИНГАЛЯЦИИ
South Africa	201003900	NOVEL DOSAGE AND FORMULATION

Supplementary Protection Certificates for DUAKLIR PRESSAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1200431	C300573	Netherlands		PRODUCT NAME: ACLIDINIUMZOUT MET EEN FARMACEUTISCH AANVAARDBAAR ANION VAN EEN EEN- OF MEERWAARDIG ZUUR, IN HET BIJZONDER ACLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/12/778/001-003EU/1/12/781/001-003 2012200720
1200431	PA2013001,C1200431	Lithuania		PRODUCT NAME: ACLIDINII BROMIDUM; REGISTRATION NO/DATE: EU/1/12/778/001 - EU/1/12/778/003, 2012 07 20 EU/1/12/781/001 - EU/1/12/781/003 20120720
1200431	92132	Luxembourg		PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
1200431	2013C/001	Belgium		PRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT EN PARTICULIER LE BROMURE D'ACLIDINIUM; AUTHORISATION NUMBER AND DATE: EU/1/12/781/001 20120725

Market Dynamics and Financial Trajectory for DUAKLIR PRESSAIR

Last updated: December 30, 2025

Executive Summary

DUAKLIR PRESSAIR (glycopyrrolate and indacaterol inhalation solution) is a combination therapy approved for maintenance treatment of chronic obstructive pulmonary disease (COPD). Its market introduction, driven by escalating COPD prevalence and evolving treatment guidelines, positions it as a significant participant in the respiratory pharmaceuticals sector. This comprehensive analysis explores the drug's current market landscape, competitive positioning, regulatory environment, revenue projections, and strategic implications. Careful consideration of key drivers, barriers, and future growth opportunities provides a strategic foundation for stakeholders aiming to optimize investments and operational trajectories.

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What Are the Fundamental Market Drivers for DUAKLIR PRESSAIR?

1. Rising COPD Prevalence and Demographics

Globally, COPD affects an estimated 200 million individuals, with prevalence projected to grow due to aging populations and smoking rates [1]. In the United States alone, approximately 16 million have diagnosed COPD, with an additional 12 million undiagnosed cases [2].

• Impact: The expanding patient population creates sustained demand for inhalation therapies like DUAKLIR PRESSAIR.
• Geographical Considerations: High-prevalence regions include North America, Europe, and Asia-Pacific — markets prioritized in marketing strategies.

2. Evolving Treatment Guidelines

The GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2023 report emphasizes personalized, stepwise management, highlighting combination therapies such as glycopyrrolate and indacaterol for moderate to severe COPD [3].

• Impact: Acceptance of dual bronchodilator therapies as first-line or maintenance treatments fosters adoption of DUAKLIR PRESSAIR.

3. Competitive Landscape and Product Differentiation

Current competitors include:

Product	Active Components	Regulatory Status	Market Share
Anoro Ellipta	Umeclidinium/Vilanterol	Approved (2014)	Leading
Ultibro Breezhaler	Indacaterol/Glycopyrronium	Approved (2014)	Major competitor
Spiolto Respimat	Tiotropium/Olodaterol	Approved (2015)	Moderate presence

DUAKLIR PRESSAIR aims to carve a niche via:

• Unique molecule combinations.
• Ease of inhalation device usage.
• Potential positioning in therapy algorithms.

4. Pricing and Reimbursement Policies

Price points impact adoption, especially in price-sensitive markets. Reimbursement coverage and formulary approvals are pivotal for market penetration [4].

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What Is the Current Regulatory and Patent Landscape?

Regulatory Approvals and Indications

• FDA (U.S.): Approved in 2018 for COPD maintenance.
• EMA (Europe): Approved with similar indications.
• Other Markets: Regulatory decisions pending or under review in Asia and Latin America.

Intellectual Property and Patent Fortification

• Patents filed for device delivery mechanism and formulation composition extend into 2030.
• Patent thickets serve as barriers against generic competition.

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How Is the Financial Trajectory Shaping Up?

Pricing Strategy and Revenue Generation

Market	Average Wholesale Price (AWP) per inhaler	Estimated Annual Revenue (per market)	Market Penetration	Revenue Projection (2023–2027)
U.S.	$350-$400	$400 million (2023)	15-20% of COPD patients	$2 billion CAGR at 8% over 5 years
Europe	€300-€350	€250 million (2023)	10-15%	€1.2 billion by 2027
Asia-Pacific	$200-$300	$100 million (2023)	5-10%	$0.6 billion by 2027

Note: Figures based on adoption rates, prevalence, and market share estimates combining market research reports [5].

Market Adoption Trends

• Initial Uptake (2018–2020): Slow due to reimbursement delays and limited formulary inclusion.
• Acceleration (2021 onward): Driven by expanded payor coverage and physician awareness.

Projected Revenue Breakdown (2023–2027)

Year	Total Revenue (USD billions)	CAGR	Key Drivers
2023	0.5	—	Launch phase, initial coverage
2024	0.6	20%	Increased formulary wins, physician adoption
2025	0.75	25%	Expanded indications, competitive positioning
2026	0.9	20%	Market expansion in emerging economies
2027	1.0	11%	Mature market stabilization

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What Are the Key Competitive Advantages and Challenges?

Advantages	Challenges	Mitigation Strategies
Differentiated molecule combo	Competitive pricing pressure	Tiered pricing negotiations
Ease of inhaler device	Brand awareness relative to established products	Aggressive marketing campaigns
Strategic patent portfolio	Potential biosimilar entries	Patent extension, innovation pipeline

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What Future Market Opportunities and Risks Exist?

Opportunities

• Emerging Markets: Rapid urbanization and air pollution drive COPD prevalence.
• Combination Therapies: Synergies with other inhaler technologies.
• Digital Health Integration: Use of inhaler sensors for adherence monitoring.

Risks

• Regulatory Delays or Rejections: Market entry impediments.
• Pricing and Reimbursement Constraints: Impact on margins and volume.
• Patent Litigation: Potential intellectual property conflicts.
• Generic Competition: Imminent or strategic biosimilar entries.

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Comparison with Similar Drugs and Market Leaders

Parameter	DUAKLIR PRESSAIR	Anoro Ellipta (Glenmark)	Spiolto Respimat (BOEHRINGER)
Active Components	Glycopyrrolate + Indacaterol	Umeclidinium + Vilanterol	Tiotropium + Olodaterol
Approval Year	2018	2014	2015
Pricing (per inhaler)	~$350	~$420	~$370
Market Penetration	Growing	Leading	Moderate

What Are the Strategic Implications for Stakeholders?

• Pharmaceutical Companies: Focus on expanding indications, patent extensions, and digital health integrations.
• Investors: Recognize growth driven by COPD prevalence and therapy shifts; monitor regulatory timelines and reimbursement policies.
• Healthcare Providers: Emphasize physician education on unique device features and optimal patient matching.

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Key Takeaways

• Robust Market Demand: COPD's rising global burden sustains a steady demand for effective inhaler therapies like DUAKLIR PRESSAIR.
• Strategic Positioning: Success hinges on formulary acceptance, payer negotiations, and competitive differentiation in efficacy and user experience.
• Revenue Growth Trajectory: Anticipated CAGR of approximately 8–10% through 2027, driven by increased adoption in mature and emerging markets.
• Competitive Landscape: Market share expansion depends on patent protection, rapid market entry, and innovations, especially against entrenched competitors.
• Risks and Opportunities: Regulatory hurdles, pricing policies, and biosimilar threats coexist with opportunities from digital health tools and market expansion.

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Frequently Asked Questions

1. How does DUAKLIR PRESSAIR compare to other combination COPD therapies?
DUAKLIR PRESSAIR offers a unique fixed-dose combination of glycopyrrolate and indacaterol, with an easy-to-use inhaler device, aligning with patient preferences for simplicity. Its efficacy is comparable to existing dual bronchodilators, with competitive pricing and patent protections offering market advantages.

2. What factors most significantly influence its market penetration?
Formulary inclusions, reimbursement policies, physician awareness, and patient adherence are pivotal. Market access strategies targeting payers and education play crucial roles.

3. What are the main regulatory barriers for DUAKLIR PRESSAIR in expanding markets?
Variations in regulatory standards, approval timelines, and dossier requirements across countries can delay or restrict access. Harmonization efforts by agencies like ICH can mitigate timeframes.

4. How will patent expirations affect DUAKLIR PRESSAIR’s market position?
Patent protections extending into 2030 provide a window for market exclusivity. However, biosimilar and generic entries could pressure prices post-patent expiry, necessitating innovation and lifecycle management.

5. Which emerging markets present the highest growth potential?
Regions with increasing COPD prevalence, improving healthcare infrastructure, and growing healthcare expenditure—such as China, India, and Southeast Asia—offer significant long-term opportunities.

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References

[1] Global Initiative for Chronic Obstructive Lung Disease (GOLD). (2023). Global strategy for diagnosis, management, and prevention of COPD.
[2] Centers for Disease Control and Prevention (CDC). (2020). COPD Surveillance.
[3] GOLD Report 2023. Global Initiative for Chronic Obstructive Lung Disease.
[4] IQVIA. (2022). Pharmaceutical Pricing and Reimbursement Report.
[5] MarketWatch. (2023). Respiratory Drugs Market Analysis.

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This document provides a strategic assessment aimed at informing pharmaceutical stakeholders, investors, and healthcare professionals considering DUAKLIR PRESSAIR's market trajectory.