Aclidinium bromide; formoterol fumarate - Generic Drug Details

What are the generic drug 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

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; 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	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; 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	10,034,867
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	8,129,405
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	RE46417
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	9,333,195

International Patents for aclidinium bromide; formoterol fumarate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2100599
Malaysia	177027
Japan	2016130248
Australia	2009224895

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	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
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

Market Dynamics and Financial Trajectory for Aclidinium Bromide and Formoterol Fumarate

Last updated: February 14, 2026

What is the current market landscape for aclidinium bromide and formoterol fumarate?

Aclidinium bromide and formoterol fumarate are inhaled therapies used primarily for chronic obstructive pulmonary disease (COPD). Their combined or individual use addresses COPD symptoms and exacerbations.

• Aclidinium bromide: Approved in 2012, marketed mainly under Tudorza Pressair (AstraZeneca) and LynRx (Glenmark).
• Formoterol fumarate: Approved in the early 2000s, marketed as Foradil or Perforomist (Novartis), and included in combination inhalers (e.g., Symbicort, Foster).

Global COPD drug sales revenue reached approximately $10 billion in 2022, with inhaled bronchodilators comprising a significant share. The respiratory drug segment is projected to grow at a compound annual growth rate (CAGR) of 4.3% (2022–2027) (source: IQVIA).

How do market share and competition shape the landscape?

Key Players

• AstraZeneca: Dominates with aclidinium bromide (Tudorza Pressair).
• Glenmark: Marketed LynRx.
• Novartis: Commercializes formoterol-based therapies.
• Teva, Mylan, Boehringer Ingelheim: Competing through generic and branded inhalers.

Market Share and Sales Data

Product	Company	Estimated 2022 Sales	Notes
Tudorza Pressair (Aclidinium Bromide)	AstraZeneca	~$900 million	Leading aclidinium sales, approved globally
Foradil/Perforomist (Formoterol fumarate)	Novartis	~$500 million	Widely used in chronic asthma and COPD
Generic Formulations	Multiple (Teva, others)	~$300 million	Gaining market share due to patent expirations

Competition and Treatment Paradigm Shift

• Fixed-dose combination inhalers (LABA/LAMA combinations) gain preference, potentially displacing monotherapies.
• Biologic therapies and new COPD targets under development could impact inhaler market dynamics.
• Increased adoption in emerging markets boosts overall revenue, although patent cliffs and regulatory hurdles temper growth.

What are the regulatory and patent outlooks?

• Patent expirations: The patent for Tudorza Pressair expires in 2028 in major markets, risking generic entry.
• Regulatory support: Both drugs are approved by the FDA, EMA, and other major agencies, with ongoing trials for new indications.
• Orphan drug status: Unlikely, as COPD is a widespread condition.

How are clinical developments influencing market prospects?

Inhaler Formulations and New Indications

• Efforts focus on improved delivery devices and once-daily formulations.
• Trials are investigating combination therapies with other bronchodilators and anti-inflammatory agents.
• The FDA granted breakthrough therapy designation for some combination products, indicating potential market entry.

Pipeline and Innovation

• Glenmark and other companies are exploring biosimilar and generic versions.
• Development of digital inhalers for adherence monitoring impacts market landscape.

What are the financial trajectories' key drivers?

Revenue Growth Factors

• Increasing COPD prevalence: projected to reach 200 million cases globally by 2030.
• Improved drug delivery technology: enhances adherence and outcome, boosting sales.
• Expanding markets: particularly in Asia-Pacific and Latin America.

Challenges

• Patent expirations threaten revenue stability.
• Regulatory hurdles for new formulations and indications.
• Competitive pricing pressures from generics and biosimilars.

What are the implications for investors and R&D?

• Monitor patent expiration timelines and biosimilar entry points.
• Focus on pipeline developments for fixed-dose combinations.
• Track regulatory decisions on new indications or delivery devices.
• Evaluate emerging markets for growth opportunities.

Key Takeaways

• The inhaler segment of COPD therapies is characterized by dominance of branded inhalers with high sales, but faces an upcoming patent cliff.
• Complementary or combination therapies influence market share dynamics, with fixed-dose inhalers gaining favor.
• Innovation in formulation, delivery, and digital health solutions are key to future growth.
• Patent expirations in 2028–2030 present risks but also opportunities for biosimilar entrants.
• The global COPD market size is expected to expand at a CAGR of 4.3%, driven by aging populations and increased diagnosis rates.

FAQs

1. When do key patents for aclidinium bromide and formoterol fumarate expire?
Patent expirations are expected around 2028 in major markets, opening the door for generic competition.

2. Are there approved biosimilars for these drugs?
Currently, biosimilars are not available for these inhaled agents, but biosimilar development is under consideration for existing branded inhalers.

3. Which regions are key for expanding COPD drug sales?
Emerging markets like China, India, and Latin America show increasing adoption due to rising COPD prevalence and improving healthcare infrastructure.

4. How is combination therapy affecting the market?
Fixed-dose combinations of LAMAs and LABAs are favored due to improved adherence, potentially reducing sales of monotherapies.

5. What technological innovations are expected to influence future sales?
Digital inhalers and once-daily formulations are poised to enhance patient compliance and clinical outcomes.

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Sources:

[1] IQVIA, "Global COPD Market Report," 2022.
[2] FDA Approved Drugs Database, 2023.
[3] AstraZeneca Investor Relations, 2022.
[4] Novartis Annual Review, 2022.
[5] MarketWatch, "COPD Drug Market Analysis," 2022.