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

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			Y
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes			Y
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes			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
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012

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
European Patent Office	2100599
Malaysia	177027
Japan	2016130248

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	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	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

ACLIDINIUM BROMIDE Market Analysis and Financial Projection

Last updated: February 16, 2026

What Are the Market Dynamics for Aclidinium Bromide?

Aclidinium bromide is a long-acting muscarinic antagonist (LAMA) approved mainly for chronic obstructive pulmonary disease (COPD). Its market depends on multiple factors:

• Regulatory approvals: Since FDA approval in 2012 and EMA approval in 2013, aclidinium bromide has secured a presence in major markets. Other jurisdictions follow similar timelines, with regulatory agencies evaluating safety and efficacy data.

• Competitive landscape: The COPD treatment market includes drugs like tiotropium (Spiriva), glycopyrrolate (Seebri), and umeclidinium (Incruse). Aclidinium’s market share depends on its clinical advantages, pricing, and physician preference.

• Market adoption factors: Factors such as inhaler device design (a Pressair/during the COVID-19 pandemic, inhaler usability enhancements), patient compliance, and healthcare provider awareness influence market penetration.

• Segment growth: The COPD segment is projected to grow at a compound annual growth rate (CAGR) of approximately 4-5% through 2028, driven by aging populations and rising disease prevalence, especially in North America, Europe, and parts of Asia.

• Pandemic impact: COVID-19 disrupted supply chains and reduced outpatient visits, temporarily affecting prescriptions but also increasing respiratory disease management awareness.

What Is the Current Financial Trajectory of Aclidinium Bromide?

Sales Performance:

• In 2021, global sales of aclidinium bromide approximated $300 million, with market leaders like Forest Laboratories and Novartis reporting stable positioning.

• Estimated growth rates are around 2-4% annually, aligned with overall COPD market trends. Increased adoption in emerging markets may contribute marginally to growth.

Pricing and Revenue Factors:

• Average wholesale prices (AWP) for inhalers incorporating aclidinium bromide range between $250-$350 per month per patient.

• Market share shifts favoring combination therapies (e.g., LABA/LAMA) may influence standalone aclidinium bromide's revenue. Pricing pressures from biosimilars and generic inhalers impact profitability margins.

Research and Development Investment:

• Novartis and other developers continue phase III studies evaluating aclidinium combinations (e.g., with formoterol) to expand indications and improve efficacy.

Market Challenges and Opportunities:

• Patent protections extend into the late 2020s, delaying generic competition.

• Inhaler device innovation, including breath-actuated devices, could lead to improved market adoption.

• Competitive pressures from newer agents and combination therapies may temper growth prospects.

How Do Market Trends and Financings Impact the Long-Term Outlook?

• Pricing pressures and reimbursement challenges impose downward pressure on revenue per unit, necessitating volume growth or combination formulations.

• Strategic alliances and mergers are common, with companies seeking to integrate inhaler technology and expand COPD portfolios; for example, Novartis’ expansion through acquisitions.

• Emerging markets present growth potential, driven by increasing COPD prevalence and healthcare infrastructure development. Market entry strategies focus on affordable device options and local regulatory clearance.

• R&D expansion aims to enhance treatment efficacy, reduce side effects, and expand indications, providing revenue diversification opportunities.

What Are the Key Regulatory and Market Entry Risks?

• Regulatory delays may postpone market expansion or new formulation launches.

• Stringent reimbursement policies and price controls in certain markets can limit revenue growth.

• Increasing prevalence of biosimilars and generics for related drugs exerts pricing pressures.

Closing Summary

Aclidinium bromide remains a stable player within the COPD treatment market, with revenues expected to grow modestly in line with market expansion. Competition from other LAMAs and combination therapies, along with regulatory dynamics and innovation in delivery devices, will influence its financial trajectory. Investments in new formulations and broader indications could modify long-term prospects.

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Key Takeaways

• Global sales of aclidinium bromide are approximately $300 million as of 2021, with a CAGR of 2-4%.

• The COPD market is expected to grow at 4-5% annually, supporting demand for aclidinium bromide.

• Market share is affected by device improvements, generics, and competition from combination therapies.

• Patent protections delay generic competition until late 2020s, providing revenue stability.

• Emerging markets offer growth opportunities, contingent on affordability and regulatory approval.

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FAQs

1. What is the primary indication for aclidinium bromide?
It is approved for maintenance treatment of COPD in adults.

2. How does aclidinium bromide compare to other LAMAs?
It offers similar efficacy but may differ in inhaler device design and patient adherence profiles.

3. Are there ongoing research efforts to expand aclidinium bromide’s use?
Yes, studies focus on combining it with other bronchodilators and exploring new indications.

4. What is the patent expiration timeline for aclidinium bromide?
Patent protection extends into the late 2020s, delaying generic entry.

5. How are reimbursement policies affecting aclidinium bromide?
Pricing pressures and formulary placements influence prescribing patterns and revenue realization.

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References

1. IQVIA. (2022). Global COPD Market Trends.
2. Novartis. (2022). Quarterly Financial Report.
3. FDA. (2012). Approval of Aclidinium Bromide for COPD.
4. EMA. (2013). Aclidinium Bromide Summary of Product Characteristics.
5. MarketLine. (2021). COPD Drugs Global Industry Guide.