ACLIDINIUM BROMIDE - Generic Drug Details

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

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

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

There is one drug master file entry for aclidinium bromide. One supplier is listed for this compound.

Summary for ACLIDINIUM BROMIDE

International Patents:	72
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	39
What excipients (inactive ingredients) are in ACLIDINIUM BROMIDE?	ACLIDINIUM BROMIDE excipients list
DailyMed Link:	ACLIDINIUM BROMIDE at DailyMed

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

Constraining patent/regulatory exclusivity:

10,085,974

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

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

Sponsor	Phase
AstraZeneca	Phase 1
QuintilesIMS, Inc.	Phase 4
Maastricht University Medical Center	Phase 4

See all ACLIDINIUM BROMIDE clinical trials

Pharmacology for ACLIDINIUM BROMIDE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ACLIDINIUM BROMIDE

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

US Patents and Regulatory Information for ACLIDINIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes	11,000,517		Y
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes	10,085,974		Y
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		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 ACLIDINIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	RE46417
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	6,681,768
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	9,333,195
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	10,034,867
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	7,078,412
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012	6,750,226

EU/EMA Drug Approvals for ACLIDINIUM BROMIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Covis Pharma Europe B.V.	Bretaris Genuair	aclidinium bromide	EMEA/H/C/002706Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).	Authorised	no	no	no	2012-07-20
Covis Pharma Europe B.V.	Eklira Genuair	aclidinium bromide	EMEA/H/C/002211Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).	Authorised	no	no	no	2012-07-20

International Patents for ACLIDINIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
Chile	2009000602
Canada	2716724
Lithuania	2954889
Croatia	P20220919
China	102083416
Brazil	PI0905775

Supplementary Protection Certificates for ACLIDINIUM BROMIDE

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	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	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
1200431	C01200431/01	Switzerland		PRODUCT NAME: ACLIDINIUM; REGISTRATION NO/DATE: SWISSMEDIC 62590 25.04.2013
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Aclidinium Bromide

Last updated: July 30, 2025

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Introduction

Aclidinium bromide, a long-acting muscarinic antagonist (LAMA), is primarily marketed for the management of chronic obstructive pulmonary disease (COPD). Since its approval, it has played a pivotal role in addressing the therapeutic needs associated with airflow limitation and exacerbations in COPD patients. As market forces evolve, understanding the dynamics and financial trajectory of aclidinium bromide offers insight into its commercial potential, competitive positioning, and future revenue streams.

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Market Overview

Global COPD Treatment Landscape
COPD remains a significant global health burden, projected to be the third leading cause of death worldwide by 2030 (World Health Organization, 2021). The disease's prevalence is rising, driven by aging populations and increased tobacco use, especially in emerging markets. This expanding patient demographic fosters sustained demand for effective bronchodilators like aclidinium bromide.

Product Profile and Regulatory Status
Aclidinium bromide is marketed under brands such as Tudorza Pressair (USA) and Eklira Genuair (Europe). It was approved by the U.S. Food and Drug Administration (FDA) in 2012 and by the European Medicines Agency (EMA) in 2013. Its fast onset of action and once or twice-daily dosing enhance patient adherence, strengthening its therapeutic appeal.

Competitive Positioning
Aclidinium competes with other LAMAs such as tiotropium, glycopyrronium, and umeclidinium, various fixed-dose combinations, and emerging biologics. Its unique delivery device and favorable safety profile serve as differentiators, although a lack of extensive head-to-head trials tempers its market penetration against entrenched competitors like tiotropium.

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Market Dynamics

Drivers

1. Rising COPD Prevalence:
   Global epidemiological data indicate a continuous increase in COPD cases, especially in Asia-Pacific and Latin America. This demographic shift guarantees a consistent demand for inhaled bronchodilators, including aclidinium bromide.

2. Innovative Drug Formulations:
   Aclidinium's inhalation device offers user-friendly features that improve medication adherence. Innovations in delivery systems and combination formulations further bolster its market appeal.

3. Expanding Indications:
   Research exploring aclidinium’s utility in other respiratory conditions, such as asthma or bronchiectasis, may unlock additional revenue streams.

4. Regulatory Approvals and Patent Extensions:
   Market exclusivity, secured through patents and regulatory periods, postpones generic entries, enabling sustained revenue growth during patent life.

Challenges

1. Intense Competition:
   Dominance of tiotropium and the rise of combination therapies limit market share. The lack of direct comparative studies diminishes comparative confidence among clinicians.

2. Pricing and Reimbursement Dynamics:
   Price sensitivity in emerging markets and reimbursement constraints in developed economies influence sales. Payers favor cost-effective combinations, pressing on standalone aclidinium bromide’s profitability.

3. Generic and Biosimilar Entry:
   Patent expirations, expected in the late 2020s, threaten future revenues, emphasizing the importance of lifecycle management strategies.

4. R&D Risks:
   Limited evidence of superior efficacy over existing LAMAs constrains promotional efforts, and unanticipated adverse effects can impair market perception.

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Financial Trajectory and Market Forecasts

Historical Financial Performance

Revenue from aclidinium bromide has historically reflected steady growth, driven by its initial market penetration and expanding indications. In 2021, global sales are estimated at approximately USD 400 million, with North America contributing over 50% due to high COPD prevalence and healthcare infrastructure. Margins remain healthy, bolstered by patent protections and brand recognition.

Forecasted Growth and Market Penetration

Projections suggest a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, reaching USD 530-600 million by 2027. This growth will be fueled by:

• Expanding markets: Particularly in Asia-Pacific, where COPD awareness and diagnosis rates increase.
• Combination therapies: Partnerships and co-formulations (e.g., aclidinium/formoterol) are anticipated to represent a growing share of sales, boosting average selling prices.
• Renewed focus on personalized medicine: Biomarker-driven approaches targeting specific patient populations may enhance drug efficacy and uptake.

Impact of Patent Expiry and Generic Competition

With patent protection anticipated to lapse around 2028-2030, market revenues are expected to decline unless the manufacturer innovates or files new formulations. Entry of generics could reduce prices by as much as 50%, sharply influencing profitability. Accordingly, strategic investments in lifecycle management, such as development of combination inhalers or novel delivery devices, are critical.

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Key Market Players and Strategic Moves

Major pharmaceutical entities include AstraZeneca and Teva Pharmaceuticals, both possessing significant COPD portfolios. Strategic collaborations focus on co-marketing, clinical trials, and pipeline expansion. For instance, Teva's development of fixed-dose combinations aims to capture a broader segment, incorporating aclidinium into comprehensive COPD treatment regimens.

Emerging competitors are investing heavily in novel LAMA/LABA combinations and biologic therapies. Therefore, continuous innovation and differentiation are vital for maintaining market share.

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Regulatory and Market Access Trends

Regulatory agencies are increasingly emphasizing real-world evidence to approve and reimburse COPD therapies. Manufacturers must demonstrate not only efficacy but also health economic benefits. For aclidinium bromide, the ability to position it as cost-effective and improve patient adherence remains pivotal to secure favorable reimbursement pathways across diverse healthcare systems.

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Conclusion

The financial trajectory of aclidinium bromide appears cautiously optimistic amid robust COPD prevalence and ongoing demand for effective bronchodilators. Market growth hinges on strategic lifecycle management, innovation in drug formulations, and expanding into emerging markets. However, competitive pressures, impending patent cliffs, and evolving reimbursement dynamics necessitate proactive adaptation to sustain profitability and market relevance.

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Key Takeaways

• Steady Growth Expectation: Global COPD prevalence supports ongoing demand, with projected revenue growth of 4-6% annually until 2027.
• Competitive Differentiation: Unique device features and combination therapies are central to maintaining market share amidst competitors.
• Lifecycle Management: Patent expiration around 2028-2030 underscores the importance of innovations such as combination inhalers to offset potential revenue declines.
• Emerging Markets: Rapid COPD diagnosis and treatment adoption in Asia-Pacific and Latin America represent significant upside.
• Regulatory Focus: Demonstrating economic advantages and patient adherence benefits is crucial for market access and reimbursement success.

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FAQs

1. When is aclidinium bromide expected to face generic competition?
Patent expiry is projected around 2028-2030, after which generic versions are likely to enter the market, potentially reducing prices and revenue margins.

2. How does aclidinium bromide compare with other LAMAs in the market?
While it offers quick onset and a user-friendly inhaler, head-to-head data remain limited. Its differentiation largely hinges on device design and safety profile rather than clear efficacy superiority.

3. What emerging markets hold the most promise for aclidinium bromide sales?
Asia-Pacific and Latin America show significant growth potential due to rising COPD prevalence, increasing healthcare infrastructure, and expanding access to inhaled therapies.

4. What strategic measures can prolong aclidinium bromide’s market relevance?
Developing fixed-dose combinations, expanding into new indications, and implementing lifecycle management initiatives are critical strategies.

5. How are reimbursement policies affecting aclidinium bromide?
Reimbursement success depends on demonstrating cost-effectiveness. Payers favor therapies that improve adherence and reduce healthcare burden, influencing market access and pricing strategies.

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References

1. World Health Organization. (2021). Global Status Report on Noncommunicable Diseases 2021.
2. European Medicines Agency. (2013). Eklira Genuair product information.
3. U.S. Food and Drug Administration. (2012). Tudora Pressair approval documentation.
4. Market research reports. (2022). COPD inhaler therapeutics market analysis.
5. Industry insights and financial disclosures from AstraZeneca and Teva annual reports (2021-2022).