ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE - Generic Drug Details

What are the generic sources for aclidinium bromide; formoterol fumarate and what is the scope of freedom to operate?

Aclidinium bromide; formoterol fumarate is the generic ingredient in one branded drug marketed by Covis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aclidinium bromide; formoterol fumarate has seventy-two patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

International Patents:	72
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	16
DailyMed Link:	ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

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.

Recent Clinical Trials for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

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

Sponsor	Phase
QuintilesIMS, Inc.	Phase 4
Maastricht University Medical Center	Phase 4
Center for Integrated Rehabilitation and Organ Failure Horn	Phase 4

See all ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE clinical trials

Pharmacology for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

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

Anatomical Therapeutic Chemical (ATC) Classes for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

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 ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

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 ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

Country	Patent Number	Title	Estimated Expiration
Peru	20190406
New Zealand	585857
Spain	2551307
Cyprus	1116926

Supplementary Protection Certificates for ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

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	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	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
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

Market Dynamics and Financial Trajectory for ACLIDINIUM BROMIDE and FORMOTEROL FUMARATE

Last updated: July 29, 2025

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Introduction

The global pharmaceutical landscape for respiratory therapies continues to experience significant shifts driven by emerging innovations, regulatory landscapes, and evolving patient needs. Among the prominent compounds in this space are Aclidinium Bromide and Formoterol Fumarate, two medications primarily indicated for chronic obstructive pulmonary disease (COPD) and asthma. Analyzing their market dynamics and financial trajectories involves understanding clinical efficacy, patent statuses, competitive environment, regulatory pathways, and shifting healthcare policies.

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Market Overview

Aclidinium Bromide and Formoterol Fumarate occupy critical niches within bronchodilator therapy, both achieving widespread adoption due to their efficacy profiles, safety, and delivery mechanisms.

• Aclidinium Bromide is a long-acting muscarinic antagonist (LAMA), approved for COPD maintenance therapy, marketed under brand names like Tudorza Pressair (USA) and Eklira Genuair (Europe). Its competitive advantage lies in its once-daily dosing, inhaler design, and minimal systemic absorption.

• Formoterol Fumarate is a long-acting beta-agonist (LABA), often used alone or in combination therapies for asthma and COPD. It is frequently embedded in combination inhalers, such as Symbicort and Dulera, offering rapid onset with prolonged duration.

Market Drivers and Dynamics

Growing Incidence of Respiratory Diseases

The increasing prevalence of COPD and asthma globally, driven by aging populations and environmental factors, fuels demand for inhaled bronchodilators. The WHO estimates COPD affects over 200 million people worldwide, with incidence expected to rise due to air pollution and tobacco use.

Innovations and Combination Therapies

Pharmacological innovation continues to boost market growth. Both drugs are now part of combination inhalers—Aclidinium with formoterol (e.g., Brimica Genuair/ Daxcaster) and others—enhancing convenience and adherence. The development of triple therapy inhalers (LABA + LAMA + ICS) leverages these compounds' synergistic effects, further expanding their market.

Regulatory and Patent Considerations

Patent expirations significantly influence market dynamics. For instance, the expiration of patent protections for key formulations of Formoterol Fumarate has prompted generic versions, intensifying competition and reducing prices. Conversely, novel delivery devices and formulations for Aclidinium Bromide, like inhaler improvements, offer opportunities for extending exclusivity.

Competitive Landscape

Major pharmaceutical companies such as AstraZeneca, Chiesi, Teva, and Novartis dominate the market with proprietary formulations. Emerging players focus on biosimilars and generic versions, challenging incumbent pricing power. Market entry barriers include regulatory approval processes and the need for demonstrating clinical superiority or added value.

Pricing and Market Access

Pricing remains a pivotal factor, especially as healthcare systems aim to balance affordability with innovation. Reimbursement policies across different regions influence the uptake of these therapies. Incentives for inhaler adherence and device ease-of-use also shape market penetration.

Financial Trajectory Analysis

Revenue Streams

The revenue for ACLIDINIUM BROMIDE and FORMOTEROL FUMARATE depends substantially on patent protections, market penetration, and the prevalence of respiratory diseases. The inhaler market's value was projected to surpass USD 30 billion globally by 2025, with significant proportions attributable to these molecules.

Impact of Patent Expirations

The loss of patent exclusivity leads to revenue decline for branded formulations (e.g., AstraZeneca's Tudorza). However, it also creates opportunities for generics, which can potentially lead to market expansion through lower-cost alternatives. Companies leveraging patent extensions through new formulations or delivery devices can sustain revenues.

Emerging Markets

Growth in Asia-Pacific, Latin America, and Africa presents untapped opportunities. The rising burden of respiratory diseases, coupled with increasing healthcare expenditure, supports proliferating sales. Local manufacturers and patent challenges in these regions could influence the financial state for incumbent firms.

Pricing Strategies and Market Penetration

Strategic pricing, insurance negotiations, and formulary placements directly influence sales volume and revenue. Innovative delivery mechanisms that improve adherence and reduce side effects may command premium pricing, positively impacting financial trajectories.

Future Outlook

Looking ahead, the financial trajectory for Aclidinium Bromide and Formoterol Fumarate appears favorable, assuming continued innovation, favorable regulatory pathways, and expanding markets. The following factors will heavily influence their future financial landscape:

• Continued pipeline development for combination therapies
• Regulatory approvals for new indications or formulations
• Entering biosimilar markets and accepting generic competition
• Deployment of digital health and adherence-enhancing technologies
• Market expansion in emerging regions

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Regulatory and Commercial Challenges

Despite promising growth, regulatory hurdles—such as changing inhaler device standards—may pose hurdles. Additionally, competitive pressures from newer molecule classes like ultra-LABAs or biologics could constrain market share gains. Health economic evaluations emphasizing cost-effectiveness will determine formulary decisions, influencing sales trajectories.

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Key Takeaways

• Disease burden growth sustains demand for bronchodilator therapies involving ACLIDINIUM BROMIDE and FORMOTEROL FUMARATE, especially within COPD and asthma markets.

• Patent expirations and generics are expected to exert downward pressure on pricing but simultaneously create opportunities via biosimilar and alternative formulations.

• Innovations in inhaler technology and combination therapies will enable companies to extend market share and maintain revenue streams.

• Emerging markets comprise substantial future revenue potentials, driven by rising disease prevalence and increasing healthcare investments.

• Regulatory developments and healthcare policy shifts will significantly dictate the pace and scope of market expansion.

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FAQs

1. How does patent expiration impact the financial outlook for ACLIDINIUM BROMIDE and FORMOTEROL FUMARATE?
Patent expiration typically leads to revenue decline for brand-name products as generics enter the market. However, it also fosters market expansion through lower-cost alternatives, which can increase overall sales volume but at reduced profit margins for original developers.

2. What role do combination inhalers play in the future market for these drugs?
Combination inhalers incorporating ACLIDINIUM BROMIDE or FORMOTEROL FUMARATE improve treatment adherence and efficacy, fostering increased adoption. They also extend product lifecycle via new formulations and are central to triple therapy regimens.

3. Which regions are expected to drive the greatest growth for these therapies?
Emerging markets in Asia-Pacific, Latin America, and Africa are poised for significant growth owing to rising disease prevalence and expanding healthcare infrastructures, often with cost-sensitive reimbursement models.

4. How do regulatory changes influence the financial trajectory of these compounds?
Stringent regulations on inhaler devices and formulations can delay approvals or require redesigns, impacting timelines and revenue. Conversely, favorable regulatory pathways for innovative delivery systems can enhance market penetration.

5. What are the key challenges facing the growth of ACLIDINIUM BROMIDE and FORMOTEROL FUMARATE?
Challenges include increasing competition from generics and biosimilars, rapid technology obsolescence, pricing pressures, and the need for sustained innovation to maintain therapeutic relevance.

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References

1. World Health Organization. (2021). Chronic obstructive pulmonary disease (COPD). https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease
2. Grand View Research. (2022). Respiratory Disease Drugs Market Size, Share & Trends Analysis Report.
3. IQVIA. (2022). The Global Use of Medicine in 2022: Outlook and Trends.
4. AstraZeneca Annual Report. (2022). Strategic review of COPD portfolio.
5. US Patent Office. (2022). Patent filings related to inhaler devices and formulations.

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