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
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
Argentina	029760	DERIVADOS DE QUINUCLIDINA, PROCESO PARA PREPARAR DICHOS DERIVADOS, COMPUESTOS INTERMEDIARIOS UTILIZABLES EN DICHO PROCESO, COMPOSICIONES FARMACEUTICAS FORMULADAS CON DICHOS DERIVADOS Y USO DE DICHOS DERIVADOS PARA LA PRODUCCION DE MEDICAMENTOS PARA EL TRATAMIENTO DE ENFERMEDADES RESPIRATORIAS, URINA
Austria	235492
Australia	2005202144
Australia	6433000
Australia	779881
Bulgaria	106301

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	CA 2013 00002	Denmark
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	92132	Luxembourg		PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
1200431	2013/002	Ireland		PRODUCT NAME: ACLIDINIUM SALT WITH A PHARMACEUTICALLY ACCEPTABLE ANION OF A MONO OR POLYVALENT ACID ESPECIALLY AS ACLIDINIUM BROMIDE; NAT REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720; FIRST REGISTRATION NO/DATE: EU/1/12/781/001-003 20/07/2012 EUROPEAN UNION EU/1/12/778/001-003 20/07/2012 EUROPEAN UNION EU/1/12/781/001-003 20120720
1200431	13C0001	France		PRODUCT NAME: SEL D'ACLIDINIUM AVEC UN ANION PHARMACEUTIQUEMENT ACCEPTABLE D'UN ACIDE MONO OU POLYVALENT, EN PARTICULIER LE BROMURE D'ACLIDINIUM; REGISTRATION NO/DATE: EU/1/12/778/001-003 20120720

Last updated: July 24, 2026

DUAKLIR PRESSAIR (Aclidinium Bromide/Formoterol Fumarate) Market Dynamics and Financial Trajectory

DUAKLIR PRESSAIR (aclidinium bromide/formoterol fumarate) is a chronic obstructive pulmonary disease (COPD) maintenance inhaler marketed in the US as a fixed-dose dual bronchodilator. Public financial disclosures and competitive market signals (pricing pressure in inhaled COPD, payer steerage toward preferred LAMA/LABA combinations, and persistent switching risk from established brands) point to a mature-category growth profile rather than a high-momentum launch curve. Revenue trajectory is therefore shaped less by incremental clinical differentiation and more by formulary access, contracting outcomes, and supply stability across device and dose strengths.

No complete, source-verifiable revenue, unit, or payer-contract time series is provided in the available input, so the financial trajectory below is limited to market-structure drivers and the commercial variables that determine DUAKLIR PRESSAIR’s realized sales.

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How does DUAKLIR PRESSAIR compete in COPD inhaler markets and what drives uptake?

What is the competitive basis for uptake

DUAKLIR PRESSAIR is positioned as a LAMA/LABA combination delivered via a dry powder inhaler (DPI). In COPD, uptake generally depends on:

• Formulary inclusion and preferred tier placement for LAMA/LABA DPIs versus rival DPIs and metered-dose inhalers (MDIs).
• Switching friction (device familiarity, training requirements, and prescriber habit) relative to incumbent DPI brands.
• Payer mandates that restrict reimbursement to a subset of inhalers within a therapeutic interchange group.

Which competitive products shape market share

The primary competitive set is other COPD dual bronchodilator inhalers, especially those with strong contracting footprints and entrenched prescriber use. Typical pressure comes from:

• Other LAMA/LABA DPI platforms with dominant pharmacy benefit penetration.
• Therapeutic “step-up” pathways where prescribers start with LAMA or LABA and escalate to LAMA/LABA based on symptoms and exacerbation risk.
• Triple-therapy substitution risk from inhaled corticosteroid (ICS) triple regimens where appropriate, which can compress the addressable population for dual bronchodilators.

Device and channel dynamics

PRESSAIR-style DPI ecosystems can gain advantages when:

• The device has established patient acceptability and lower perceived technique failure.
• Pharmacies and clinics can operationalize training and adherence workflows.
• Managed care prefers DPI delivery to reduce administration complexity.

At the same time, DPI-focused competition increases risk of:

• Cross-brand switching when payers enforce step-edit rules.
• Technique failure complaints that drive short cycles of re-prescribing.

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What is the DUAKLIR PRESSAIR revenue trajectory after launch and how do market forces affect it?

Expected stage profile in a mature inhaled COPD category

Because DUAKLIR PRESSAIR sits in a mature COPD inhaler category with many established alternatives, the most likely financial pattern is:

• Early penetration driven by formulary placement and prescriber conversion from monotherapy or free-standing LAMA/LABA equivalents.
• Subsequent growth constrained by class saturation, with gains mostly offset by pricing resets and contracting outcomes across the class.

Primary determinants of realized sales

Realized revenue in inhaled COPD is dominated by:

• Net price and discounting: class-wide rebate intensity can lower effective revenue even when units rise.
• Contracting and utilization controls: tier placement and prior authorization restrictions determine persistence.
• Exacerbation-management patterns: when clinicians increase ICS use, dual bronchodilator share can erode.
• Substitution to competitors with stronger PBM relationships: the incremental benefit of the product matters less once payer rules dominate.

Financial trajectory signals to monitor

Even without a numeric time series, the commercial trajectory can be evaluated using common market KPIs:

• Script velocity and refill persistence (adherence proxies for chronic inhalers).
• Channel inventory and distribution (risk of post-launch pull-through pauses).
• Share of new starts vs switches (switching often drives volatility in COPD).
• Formulary changes across major PBMs and Medicaid plans.

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When do COPD inhaler market dynamics shift toward triple therapy and what does that mean for DUAKLIR PRESSAIR?

How ICS triple therapy affects dual bronchodilator economics

In the US, dual bronchodilators face category pressure when prescribers and payers move patients into ICS-containing triple regimens. This can happen when:

• A patient history supports exacerbation risk.
• Inadequate control drives escalation.
• Payers create preferential access for triple therapy options.

Economic impact mechanism

Triple therapy adoption can reduce DUAKLIR PRESSAIR addressable patient share through:

• Step-up displacement: dual bronchodilator users convert once symptoms or exacerbations trigger escalation.
• Contract-driven substitution: preferred status for a triple inhaler can shift prescriber ordering behavior.

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What patents protect DUAKLIR PRESSAIR and how does IP shape long-term commercial outlook?

Patent estate impact on competitive entry

DUAKLIR PRESSAIR’s longer-horizon financial trajectory is sensitive to:

• Expiration of composition, formulation, and device-related patents.
• Method-of-use coverage (if present) that can delay certain generic or biosimilar-like substitution pathways (though small molecule inhalers differ from biologics).

Generic entry risk framework (small-molecule inhaler)

For inhaled small molecule combinations, generic entry risk generally depends on:

• Regulatory and patent posture in Orange Book for drug substance, drug product, and use claims.
• Paragraph IV litigation outcomes if challenged.
• Practical barriers for equivalent inhaler performance in real-world usage, including dose uniformity and device-engineering considerations.

No Orange Book listing, patent numbers, or expiration dates are included in the provided input, so the protective scope and timing cannot be enumerated here.

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What is the Orange Book status of DUAKLIR PRESSAIR and where are the key exclusivity cliffs?

No Orange Book entries, exclusivity periods, or patent expiration dates are provided in the available input. As a result, this section cannot be populated with verified exclusivity cliffs, listed patents, or litigation-linked timelines.

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Is DUAKLIR PRESSAIR exposed to FDA Paragraph IV challenges or authorized generics?

No FDA Paragraph IV, ANDA submissions, or settlement descriptions are included in the available input. This prevents a factual assessment of challenge probability, suit triggers, or authorized generic risk.

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How does DUAKLIR PRESSAIR compare with other LAMA/LABA combinations on commercial and execution metrics?

What tends to matter most commercially

Across LAMA/LABA COPD inhalers, performance in the market often aligns with:

• Formulary access depth across commercial and government formularies.
• PBM coverage stability during contract renegotiation cycles.
• Device learning curve and patient persistence.

Why DPI vs MDI mix matters

DPI competitors can gain traction if:

• They reduce perceived coordination burden.
• They align with patient preference for breath-actuated or powder-based delivery.

MDI competitors can gain if:

• They offer easier technique for patients with poor inspiratory flow.
• They fit managed-care preferences for specific device families.

DUAKLIR PRESSAIR’s financial trajectory is therefore best interpreted through payer coverage and patient persistence rather than purely through clinical endpoint readouts.

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What pricing and payer dynamics determine DUAKLIR PRESSAIR net sales and gross-to-net compression?

Gross-to-net compression as the core financial lever

For inhaled COPD, gross-to-net is usually driven by:

• Manufacturer rebates tied to formulary position.
• Performance-based contracting with PBMs.
• Limits imposed by Medicare Part D and Medicaid managed care rules.

Rebate intensity and net realization

In categories with many close substitutes, net prices often compress as:

• Formularies narrow to “preferred” SKUs.
• Competitors bid for preferred tiers.
• Utilization shifts increase manufacturer discount pressure.

Without numeric net pricing disclosures in the provided input, no quantified margin trajectory can be stated.

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What settlements, litigation, or licensing arrangements could alter DUAKLIR PRESSAIR market access?

No litigation or licensing agreements are included in the available input. This prevents a factual summary of settlement timing, brand protection strength, or generic launch constraints.

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Key takeaways

• DUAKLIR PRESSAIR’s commercial outcomes depend primarily on COPD payer contracting, formulary placement, and patient persistence in a saturated dual bronchodilator class.
• The most likely financial trajectory is mature-category growth with volatility driven by gross-to-net compression, switching dynamics, and triple-therapy displacement.
• Patent, Orange Book, and Paragraph IV timing are decisive for long-run exposure to generics, but no verified IP or exclusivity dataset is present in the available input, so no timelines can be stated.

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FAQs

1. How do PBM formulary switches affect DUAKLIR PRESSAIR script volume in the US?
   Formulary tier changes and prior authorization requirements typically drive abrupt utilization shifts and can reduce new starts even when baseline patient prevalence stays stable.

2. Does the PRESSAIR DPI delivery platform influence adherence and persistence versus other COPD inhalers?
   DPI technique and inspiratory flow requirements influence effective use, which can affect refill persistence and perceived outcomes in real-world settings.

3. What is the main pathway for DUAKLIR PRESSAIR to lose share to COPD triple therapy?
   Step-up escalation from dual bronchodilation to ICS-containing regimens after symptom worsening or exacerbation history, compounded by payer preference for triple therapy SKUs.

4. What financial KPI best predicts DUAKLIR PRESSAIR net sales direction during a contract cycle?
   Gross-to-net realization (rebate rate) alongside script velocity and refill persistence typically determines whether unit gains translate into revenue growth.

5. How does generic entry risk typically show up in inhaled COPD brands before launch?
   Expect pre-entry utilization pressure through switching behavior and increased rebate demands as payers anticipate alternatives, even before an ANDA is approved.

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References (APA)

1. No external sources were provided in the prompt; no citations can be generated from the available input.