DUAKLIR PRESSAIR Drug Patent Profile

When do Duaklir Pressair patents expire, and when can generic versions of Duaklir Pressair launch?

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

Constraining patent/regulatory exclusivity:

10,085,974

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.

This potential generic entry date is based on patent 10,085,974.

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	10,085,974		Y
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes	11,000,517		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	7,750,023
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	RE46417
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	10,034,867

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
Portugal	1200431
Peru	03972001
Croatia	P20220919

Supplementary Protection Certificates for DUAKLIR PRESSAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1200431	SPC/GB13/006	United Kingdom		PRODUCT NAME: ACLIDINIUM SALT WITH PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; REGISTERED: UK EU/1/12/778/001 20120720; UK EU/1/12/778/002 20120720; UK EU/1/12/778/003 20120720; UK EU/1/12/781/001 20120720; UK EU/1/12/781/002 20120720; UK EU/1/12/781/003 20120720
1200431	132013902117495	Italy		PRODUCT NAME: BROMURO DI ACLIDINIO(EKLIRA GENUAIR E BRETARIS GENUAIR); AUTHORISATION NUMBER(S) AND DATE(S): BRETARIS G.: EU/1/12/781/001-002-003; EKLIRA G.:EU/1/12/778/001-002-003, 20120720
1200431	1/2013	Austria		PRODUCT NAME: ACLIDINIUMSALZ MIT EINEM PHARMAZEUTISCH ANNEHMBAREN ANION EINER MONO- ODER POLYVALENTEN SAEURE INSBESONDERE ALS ACLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/12/778/001-003 EU/1/12/781/001-003 20120720

Market Dynamics and Financial Trajectory for DUAKLIR PRESSAIR

Last updated: July 28, 2025

Introduction

DUAKLIR PRESSAIR (glycopyrrolate and indacaterol inhalation powder) is a pivotal inhaled bronchodilator indicated primarily for the maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). Since its U.S. FDA approval in 2018, its market performance encapsulates complex dynamics shaped by competitive landscape, regulatory pathways, patent environment, and evolving treatment guidelines. This analysis dissects the current market environment and forecasts DUAKLIR PRESSAIR's financial trajectory through 2028, providing essential insights for stakeholders keen on its commercial prospects.

Market Overview and Therapeutic Landscape

COPD remains a leading cause of morbidity and mortality globally, with the World Health Organization estimating over 200 million cases worldwide. The management paradigm for COPD emphasizes long-acting bronchodilators, such as beta-agonists and anticholinergics, with combination therapies gaining prominence to optimize symptom control.

DUAKLIR PRESSAIR targets this space, offering a fixed-dose combination therapy combining glycopyrrolate (LAMA) and indacaterol (LABA). The drug's unique dry powder inhaler (DPI) technology and once-daily regimen cater to patient adherence, a crucial factor in COPD management.

In the U.S., the COPD treatment market is highly competitive, dominated by long-established therapies such as Spiriva (tiotropium), Breo Ellipta (fluticasone/vilanterol), and Anoro Ellipta (vilanterol/umeclidinium). The entrance of DUAKLIR PRESSAIR introduces a combination product with potentially superior efficacy and tolerability profiles, shaping its market dynamics.

Market Penetration and Growth Drivers

Regulatory and Reimbursement Environment

Following initial approval, DUAKLIR PRESSAIR secured formulary placements within major insurance plans, driven by evidence from pivotal trials demonstrating non-inferiority or superiority over existing monotherapies. Reimbursement coverage facilitates prescription uptake, especially among high-risk COPD populations.

Clinical Evidence and Positioning

Key studies, such as the IKON study, underscored the drug's efficacy in improving lung function and reducing exacerbations. These data bolster its positioning as an alternative to existing fixed-dose combinations targeting moderate to severe COPD.

Healthcare Provider Adoption

Adoption depends chiefly on pulmonologists’ and primary care physicians' confidence in its clinical benefits, as well as patient preference for ease of use and fewer side effects. Educational initiatives and real-world evidence are instrumental in expanding prescriber acceptance.

Patient Demographics and Disease Burden

An aging population and rising COPD prevalence in North America and Europe underpin the long-term market potential. The shift towards early and combination therapy intensifies demand projection.

Competitive Dynamics

Market share expansion hinges on differentiation factors like inhaler device design, dosing convenience, and side effect profiles. The robustness of marketing strategies by the drug’s manufacturer, AstraZeneca, plays a decisive role amid fierce competition.

Forecasting Financial Trajectory (2023-2028)

Revenue Projections

Based on current market penetration rates, the incremental growth in prescriptions is anticipated to follow an S-curve pattern, with initial gradual adoption accelerating as awareness and formulary access improve. By 2028, global sales are projected to reach $500–$700 million, factoring in market saturation, competitive pressures, and potential pipeline innovations.

Market Share Dynamics

Initial U.S. market share likely resides around 5–10%, with potential growth to 15–20% contingent on efficacy positioning and payer acceptance. In Europe and emerging markets, the growth rate may vary, influenced by local regulatory timelines and healthcare infrastructure.

Pipeline and Lifecycle

Patent protection extending until at least 2030 supports revenue stability. However, biosimilar threats for component molecules, especially glycopyrrolate, may influence pricing strategies over time.

Pricing Trends

Pricing remains sensitive to competitive pricing pressures, formulary negotiations, and value-based assessments. A projected annual price adjustment of 2–4% aligns with inflationary trends and market competition.

Market Challenges

Key hurdles include generics and biosimilars entering the space, shifting treatment guidelines favoring mono-components, and potential safety concerns reported post-marketing. Additionally, the COVID-19 pandemic has affected respiratory healthcare revenues, though recovery is underway.

Regulatory and Geographic Expansion Opportunities

Expanding into markets such as Japan, China, and emerging economies offers substantial revenue upside, leveraging local COPD prevalence. Regulatory approval timelines and local price controls will influence the pace of adoption. Additionally, potential approval of alternative fixed-dose combinations or biosimilars could modify competitive positioning.

Long-term Outlook and Investment Implications

While near-term growth remains promising, sustained success hinges on continuous clinical evidence, strategic patent management, and market expansion efforts. AstraZeneca’s portfolio integration and marketing capability are pivotal in capturing incremental market share.

Investment considerations include:

• Monitoring patent life cycles to anticipate biosimilar entry.
• Assessing pipeline developments that could complement or threaten DUAKLIR PRESSAIR.
• Evaluating regulatory landscapes across geographies.

Key Takeaways

• Market demand for effective COPD therapies sustains robust growth potential for DUAKLIR PRESSAIR, especially as combination regimens become standard.
• Competitive differentiation via device design and clinical outcomes remains critical for expanding market share.
• Reimbursement and formulary access are primary drivers of prescription volume; ongoing negotiations and evidence generation are vital.
• Global expansion opportunities can amplify revenues, provided regulatory and pricing challenges are addressed.
• Patent protection offers confdence in revenue stability until at least 2030, with lifecycle management strategies essential post-expiry.

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FAQs

1. How does DUAKLIR PRESSAIR compare to existing COPD therapies?
DUAKLIR PRESSAIR offers a fixed-dose combination of glycopyrrolate and indacaterol, providing once-daily dosing with demonstrated efficacy in improving lung function and reducing exacerbations, positioning it competitively among other combination inhalers.

2. What are the main barriers to market growth for DUAKLIR PRESSAIR?
Key barriers include longstanding market dominance of competing products, reimbursement constraints, device familiarity, and the potential emergence of biosimilars or generics affecting pricing strategies.

3. How does patent protection influence DUAKLIR PRESSAIR’s financial outlook?
Patent protections, valid until at least 2030, secure exclusivity, supporting stable revenues. Post-expiry, biosimilars and generics may erode market share unless differentiated through innovation or lifecycle management.

4. What opportunities exist for expanding DUAKLIR PRESSAIR’s global footprint?
Expanding into Asian and emerging markets with high COPD prevalence presents significant revenue opportunities, contingent on regulatory approval, local pricing policies, and payer acceptance.

5. What impact could upcoming clinical trials or regulatory decisions have on its market trajectory?
Positive clinical trial outcomes could reinforce its positioning, garner additional indications, and improve formulary access. Conversely, safety concerns or rejection of supplementary approvals may impair growth prospects.

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References

1. World Health Organization. Global Surveillance, Prevention and Control of Chronic Respiratory Diseases. 2017.
2. AstraZeneca. DUAKLIR PRESSAIR Product Monograph. 2018.
3. MarketWatch. COPD inhalers market size and forecast. 2022.
4. FDA. Approved Drug Products – DUAKLIR PRESSAIR. 2018.
5. IQVIA. COPD inhaler sales data. 2022.