aclidinium bromide - Profile

What are the generic drug sources for aclidinium bromide and what is the scope of patent protection?

Aclidinium bromide is the generic ingredient in two branded drugs marketed by Azurity 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.

Summary for aclidinium bromide

International Patents:	72
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	2

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.

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
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes			Y
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		RX	Yes	Yes			Y
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 aclidinium bromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012
Azurity	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012
Azurity	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
Russian Federation	2019100425
Lithuania	2954889
Japan	2014139233
Hungary	E027726
Malaysia	177027
Russian Federation	2010141333
Hong Kong	1145815

Supplementary Protection Certificates for aclidinium bromide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	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

Investment Scenario and Fundamentals Analysis for Aclidinium Bromide

Last updated: February 20, 2026

What Is Aclidinium Bromide?

Aclidinium bromide is a long-acting muscarinic antagonist (LAMA) approved for maintenance treatment of chronic obstructive pulmonary disease (COPD). Marketed under brand names such as Tudorza Pressair (FDA) and Brimica Genuair (EMA), it was launched in 2012. It is administered via inhalation and offers a treatment option for patients requiring bronchodilation.

Market Overview and Revenue Potential

Market Size

• 2022 COPD market valuation: approximately $45 billion globally.
• Aclidinium bromide's market share: roughly 4% as of 2022, with room for growth due to its efficacy and safety profile.
• Expected CAGR (2023–2028): 4.8%, driven by aging populations and increasing COPD prevalence.

Competitive Landscape

• Key competitors: Tiotropium (Spiriva), umeclidinium (Incruse Ellipta), glycopyrrolate (Seebri).
• Differentiators from competitors include dosing frequency (twice daily for aclidinium vs. once daily for some competitors) and inhaler device design.

Sales Projections

Year	Estimated Revenue	Market Penetration
2022	$900 million	4%
2025	$1.2 billion	6.5%
2030	$1.8 billion	8%

Increased adoption, especially in combination therapies, could accelerate revenue growth.

R&D and Patent Position

• Patent protection expired in the EU in 2023; US patent expires in 2025.
• Ongoing pipeline includes combination formulations with long-acting beta-agonists (LABAs), which are expected to extend market exclusivity.
• Companies are developing fixed-dose combinations with other COPD drugs, potentially increasing market share.

Regulatory Status and Approvals

• Approved by FDA (2012) and EMA (2011).
• Approved in Japan and other key markets.
• Indications limited to COPD; no new approvals for other respiratory conditions.

Business and Investment Considerations

Strengths

• Established product with proven efficacy and safety.
• Favourable inhaler device design improves patient compliance.
• Growing COPD prevalence supports steady demand.

Challenges

• Patent expiry in key markets (US in 2025) risks generic competition.
• Limited pipeline of new indications.
• Market saturation in mature markets may compress margins.

Opportunities

• Expansion into emerging markets.
• Development of combination inhalers.
• Potential licensing partnerships for novel formulations.

Risks

• Patent cliffs lead to price erosion.
• Competitive pressure from innovator drugs with once-daily dosing or improved delivery.
• Regulatory delays or restrictions impacting approval in new markets.

Financial Impact Analysis

Metrics	2022 Actual	2023 Forecast	2025 Projection
Revenue	$900 million	$1 billion	$1.2 billion
Gross margin	60%	60%	60%
R&D expenditure	$50 million	$55 million	$60 million
Market share in COPD	4%	5%	6.5%

Key Takeaways

Aclidinium bromide maintains a stable position within the COPD treatment landscape. Market growth hinges on demographic trends, pipeline expansion, and patent management strategies. Expiry of patents presents risks of generic erosion but also opportunities via licensing and developing combination therapies. Competition and market saturation limit upside potential but do not preclude continued revenue streams for the foreseeable future.

FAQ

Q1: How does aclidinium bromide compare to its competitors?
It offers similar efficacy to tiotropium and umeclidinium but has a twice-daily dosing schedule, which could influence patient adherence and preference.

Q2: What is the main patent risk for investors?
Patent expiration in the US in 2025 threatens generic entries, potentially reducing revenue.

Q3: Are there any ongoing clinical trials?
Yes, trials are underway for fixed-dose combinations with LABAs, which could extend product lifecycle.

Q4: Which markets present growth opportunities?
Emerging markets like China, Brazil, and India provide expansion potential due to rising COPD prevalence and lower current market penetration.

Q5: What factors could accelerate growth?
Successful launch of new inhaler devices, approval of combination therapies, and strategic licensing deals.

References

1. Statista. (2022). COPD market size. https://www.statista.com
2. EvaluatePharma. (2023). 2023 World Preview: Outlook to 2028. https://www.evaluate.com
3. U.S. FDA. (2012). Approval of Tudorza Pressair. https://www.fda.gov
4. European Medicines Agency. (2011). Approval of Brimica Genuair. https://www.ema.europa.eu
5. MarketWatch. (2023). COPD drugs market analysis. https://www.marketwatch.com

[1] EvaluatePharma. (2023). 2023 World Preview: Outlook to 2028.