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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aclidinium bromide; formoterol fumarate has one hundred and fifty-six patent family members in forty-six countries.

Two suppliers are listed for this compound.

Summary for aclidinium bromide; formoterol fumarate

International Patents:	156
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
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:

RE46417

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	8,051,851		Y
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		RX	Yes	Yes	RE46417		Y	Y
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019		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

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	7,750,023
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	9,056,100
Covis	DUAKLIR PRESSAIR	aclidinium bromide; formoterol fumarate	POWDER, METERED;INHALATION	210595-001	Mar 29, 2019	8,129,405

International Patents for aclidinium bromide; formoterol fumarate

Country	Patent Number	Title	Estimated Expiration
Austria	235492
Uruguay	31687	NUEVA DOSIFICACION Y FORMULACION
Montenegro	02286	JEDINJENJE ZA INHALACIJU KOJE SADRŽI AKLIDINIJUM ZA LEČENJE HRONIČNE OPSTRUKTIVNE BOLESTI PLUĆA (INHALATION COMPOSITION CONTAINING ACLIDINIUM FOR TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
Spain	2193098

Supplementary Protection Certificates for aclidinium bromide; formoterol fumarate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1200431	132013902117495	Italy		PRODUCT NAME: BROMURO DI ACLIDINIO(EKLIRA GENUAIR E BRETARIS GENUAIR); AUTHORISATION NUMBER(S) AND DATE(S): BRETARIS G.: EU/1/12/781/001-002-003; EKLIRA G.:EU/1/12/778/001-002-003, 20120720
1200431	C 2013 002	Romania		PRODUCT NAME: SAREDE ACLIDINIU CU UN ANION ACCEPTABIL FARMACEUTIC AL UNUI ACID MONO SAU POLIVALENT, IN SPECIAL BROMURA DEACLIDINIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/778/001, RO EU/1/12/778/002, RO EU/1/12/778/003; DATE OF NATIONAL AUTHORISATION: 20120720; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/778/001, EMEA EU/1/12/778/002, EMEA EU/1/12/778/003; DATE OF FIRST AUTHORISATION IN EEA: 20120720
1200431	92132	Luxembourg		PRODUCT NAME: SEL D ACLIDINIUM AVEC ANION D UN ACIDE MONO OU POLYVALENT PHARMACEUTIQUEMENT ACCEPTABLE PARTICULIEREMENT LE BROMURE D ACLIDINIUM
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

Aclidinium bromide; formoterol fumarate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aclidinium Bromide/Formoterol Fumarate

Introduction to Aclidinium Bromide/Formoterol Fumarate

Aclidinium bromide/formoterol fumarate, marketed under the name Duaklir® Genuair®, is a fixed-dose combination (FDC) of two long-acting bronchodilators: aclidinium bromide, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-agonist (LABA). This combination is designed to treat chronic obstructive pulmonary disease (COPD), a progressive and chronic condition affecting approximately 300 million people worldwide[1].

Market Approval and Regulation

The drug received Marketing Authorisation from the European Commission in November 2014 for use in the European Union and the European Economic Area. This approval was based on efficacy and safety data from over 2,000 patients in 11 clinical studies conducted across 29 countries[1].

In addition to European approval, the drug has undergone further clinical trials, such as the AVANT phase 3 clinical trial, which demonstrated statistically significant and clinically important outcomes in patients with moderate to severe stable COPD. This trial was conducted in several countries including China, Taiwan, India, Vietnam, and the Philippines[2].

Mechanism of Action and Therapeutic Benefits

Aclidinium bromide works by inhibiting the muscarinic M3 receptor in the airway smooth muscle, leading to bronchodilation. Formoterol fumarate stimulates the β2-receptors in the bronchial smooth muscle, also resulting in bronchodilation. The combination of these two mechanisms provides a synergistic effect, improving lung function and exercise tolerance in COPD patients[3].

Clinical Efficacy

Clinical studies have consistently shown that the combination of aclidinium bromide and formoterol fumarate significantly improves bronchodilation and reduces dyspnea compared to monotherapy or placebo. For example, the 24-week Phase III study demonstrated significant improvements in forced expiratory volume in 1 second (FEV1) and Transition Dyspnoea Index (TDI) focal score[5].

Safety Profile

The safety profile of aclidinium bromide/formoterol fumarate has been found to be comparable to that of the individual components and placebo. No new safety concerns were raised in the AVANT trial, and the findings were consistent with the known safety profiles of aclidinium bromide and formoterol fumarate[2].

Market Dynamics

Growth Drivers

• Increasing Prevalence of COPD: The growing number of COPD cases globally drives the demand for effective treatments. Approximately 300 million people worldwide live with COPD, making it a significant market[1].
• Advancements in Treatment Options: The development of fixed-dose combinations like aclidinium bromide/formoterol fumarate offers improved efficacy and convenience, attracting more patients and healthcare providers[3].
• Expanding Global Reach: The drug's approval and positive clinical trial results in various regions, including Asia, are expected to expand its market reach and penetration[2].

Challenges

• Competitive Landscape: The COPD treatment market is highly competitive, with several established and new treatments available. This competition can impact market share and pricing strategies[4].
• Regulatory Hurdles: Navigating regulatory approvals in different regions can be challenging and time-consuming, affecting the drug's market entry and expansion[1].
• Cost and Accessibility: The cost of the treatment and accessibility issues in some regions can limit its adoption and market growth[4].

Financial Trajectory

Revenue Potential

The approval and positive clinical outcomes of aclidinium bromide/formoterol fumarate have positioned it for significant revenue potential. As the drug expands its market presence, especially in regions like Asia, it is expected to contribute substantially to the revenue of its manufacturers and distributors.

Ownership and Licensing

AstraZeneca initially developed and commercialized Duaklir® Genuair®, but in November 2021, the global rights for Duaklir and Eklira (aclidinium bromide) were transferred to Covis Pharma. This transfer is part of Covis Pharma's strategy to expand its global respiratory portfolio[2].

Market Share

The market share of aclidinium bromide/formoterol fumarate is expected to grow as it becomes more widely available and recognized for its efficacy. The drug's performance in clinical trials and its approval in multiple regions will likely increase its market share in the COPD treatment segment[4].

Key Takeaways

• Effective Treatment Option: Aclidinium bromide/formoterol fumarate is a highly effective treatment for COPD, offering significant improvements in lung function and exercise tolerance.
• Global Expansion: The drug has been approved in the EU and is undergoing regulatory processes in other regions, including Asia.
• Competitive Market: The COPD treatment market is competitive, but the drug's unique combination and positive clinical outcomes position it favorably.
• Revenue Potential: The drug has substantial revenue potential due to its efficacy and expanding market reach.

FAQs

Q: What is the mechanism of action of aclidinium bromide/formoterol fumarate? A: Aclidinium bromide inhibits the muscarinic M3 receptor, while formoterol fumarate stimulates the β2-receptors, both leading to bronchodilation[3].

Q: In which regions has aclidinium bromide/formoterol fumarate been approved? A: It has been approved in the European Union and is undergoing regulatory processes in other regions, including Asia[1][2].

Q: What are the key benefits of using aclidinium bromide/formoterol fumarate for COPD? A: The combination provides significant improvements in lung function, exercise tolerance, and reduces dyspnea compared to monotherapy or placebo[5].

Q: Who currently owns the global rights for Duaklir and Eklira? A: Covis Pharma owns the global rights for Duaklir and Eklira, having acquired them from AstraZeneca in November 2021[2].

Q: What are the potential challenges for the market growth of aclidinium bromide/formoterol fumarate? A: Challenges include a competitive market landscape, regulatory hurdles, and issues related to cost and accessibility[4].

Sources

1. AstraZeneca Press Release: "Duaklir® Genuair® approved in the European Union for chronic obstructive pulmonary disease (COPD)"[1].
2. Covis Pharma Announcement: "Covis Pharma Announces Positive Topline Results from the AVANT Phase 3 Clinical Trial"[2].
3. PubMed Article: "Aclidinium bromide and formoterol fumarate for the maintenance treatment of chronic obstructive pulmonary disease"[3].
4. Patsnap Synapse: "Aclidinium Bromide/Formoterol Fumarate"[4].
5. PubMed Article: "Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combination in patients with COPD"[5].