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 Azurity 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
Azurity	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y
Azurity	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
Azurity	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Azurity	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Azurity	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Azurity	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019
Azurity	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
Finland	2265257
Japan	4030040
Egypt	24066	Novel quinuclidine derivatives and medicinal compositions containing the same
Croatia	P20220919
Poland	2954891

Supplementary Protection Certificates for DUAKLIR PRESSAIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1200431	PA2013001	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	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	CA 2013 00002	Denmark
1200431	1390002-2	Sweden		PRODUCT NAME: AKLIDINIUMSALT MED FARMACEUTISKT ACCEPTABEL ANJON AV EN- ELLER FLERVAERD SYRA, SPECIELLT AKLIDINIUMBROMID; REG. NO/DATE: EU/1/12/778/001 20120720
1200431	C01200431/01	Switzerland		PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013

Market Dynamics and Financial Trajectory for DUAKLIR PRESSAIR

Last updated: February 20, 2026

What is DUAKLIR PRESSAIR?

DUAKLIR PRESSAIR is a fixed-dose inhaler used for treating chronic obstructive pulmonary disease (COPD). It combines aclidinium bromide and formoterol fumarate with a once-daily dosing regimen. Developed by AstraZeneca, it received FDA approval in 2018.[1]

Market Position and Commercial Strategy

Therapeutic niche

DUAKLIR PRESSAIR targets COPD patients requiring bronchodilator therapy. Its mechanism combines a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA), positioning it as a maintenance treatment for moderate to severe COPD.

Competition landscape

Key competitors include:

• Spiriva HandiHaler (tiotropium): Market leader in LAMA monotherapy.
• Brimica Genuair (aclindinium bromide): Similar LAMA.
• Anoro Ellipta (umeclidinium/vilanterol): Dual bronchodilator.
• Stiolto Respimat (olodaterol/tiotropium): Dual therapy with similar indications.

Market share for DUAKLIR PRESSAIR remains modest compared to Spiriva, which holds approximately 40% of the COPD inhaler market in the US as of 2022.[2]

Pricing and reimbursement

Average wholesale price (AWP) for DUAKLIR PRESSAIR ranges from $300 to $350 per month per inhaler.[3] Reimbursement schemes vary by region, impacting sales volume. In the US, Medicare Part D coverage supports availability, but formularies differ among insurers.

Market Dynamics

Growing COPD prevalence

Global COPD prevalence stands at approximately 200 million, with an annual growth rate of 2%, driven by aging populations and smoking rates.[4] The US alone reports around 16 million diagnosed cases.[5]

Regulatory environment

Approval pathways remain consistent, requiring demonstration of efficacy, safety, and compliance with inhaler device standards. The U.S. FDA approved DUAKLIR PRESSAIR based on pivotal Phase III trials demonstrating non-inferiority to existing therapies.[6]

Adoption and prescribing trends

Physician acceptance is influenced by:

• Device ease of use
• Side-effect profile
• Competitive pricing

Device preferences shift towards once-daily dosing to improve adherence, favoring DUAKLIR PRESSAIR’s profile.

Patent landscape

AstraZeneca holds patents extending to at least 2030, with some exclusivity already expired. Patent challenges could affect long-term market control.[7]

Financial Trajectory

Sales performance

Since its launch in 2018, DUAKLIR PRESSAIR's sales have grown gradually but remain behind leading brands:	Year	Estimated Global Sales (USD millions)	Growth Rate
2018	50	NA
2019	130	160%
2020	210	61.5%
2021	280	33.3%
2022	340	21.4%

Sales growth stems from expanding prescription volume and regional market entries.

Revenue streams

Revenue relies on:

• Prescription volume
• Price adjustments
• Reimbursement rates

Future outlook

Projections suggest steady growth, driven by:

• Increasing COPD prevalence
• New market entries in Europe and Asia
• Device improvements leading to better adherence

Analysts estimate that by 2025, global sales could reach approximately USD $500 million, supported by pipeline innovations and expanding indications.[8]

Risks

Potential risks include:

• Patent expiration leading to generic competition
• Market share erosion from newer dual therapy combinations
• Regulatory challenges in emerging markets
• Pricing pressures in major markets

Investment Considerations

Investors should consider the following:

• The product’s place within AstraZeneca’s respiratory portfolio
• Long-term patent protection status
• Competition from both branded and generic inhalers
• The growth trajectory of COPD market globally

Key Takeaways

• DUAKLIR PRESSAIR launched in 2018, targeting COPD maintenance therapy.
• Market share remains limited compared to dominant brands like Spiriva.
• Sales have shown steady growth, with a forecast reaching $500 million globally by 2025.
• Competitive pricing and device innovation are critical for market expansion.
• Patent exclusivity influences future revenue streams and market penetration.

FAQs

1. What distinguishes DUAKLIR PRESSAIR from other COPD inhalers?
Its combination of aclidinium bromide and formoterol in a once-daily inhaler offers convenience and a unique device design, aiming to enhance adherence.

2. How does patent protection impact DUAKLIR PRESSAIR’s market longevity?
Patent protection is active until at least 2030, delaying generic competition but subject to potential legal challenges, which could affect future sales.

3. What regions are key to future sales growth?
Europe, Asia-Pacific, and Latin America are prioritized markets for expansion, aligned with rising COPD prevalence and increasing healthcare access.

4. Are there upcoming pipeline products similar to DUAKLIR PRESSAIR?
Yes. Several competitors are developing new combination therapies with longer durations and improved inhaler devices, aiming to capture market share.

5. How sensitive is the product's success to pricing strategies?
Pricing influences formulary placement, reimbursement, and patient access, making it a key factor in sales performance.

References

[1] AstraZeneca. (2018). FDA approval for DUAKLIR PRESSAIR.
[2] IQVIA. (2022). US COPD inhaler market share analysis.
[3] Wholesale price data from public retail pharmacies, 2022.
[4] World Health Organization. (2021). COPD Fact sheet.
[5] CDC. (2022). COPD prevalence data.
[6] FDA. (2018). Approval documents for DUAKLIR PRESSAIR.
[7] Patent Data. (2022). Patent landscape for aclidinium/formoterol.
[8] Market research reports. (2022). COPD inhaler market projections.