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

Aclidinium bromide has one hundred and fifty-six patent family members in forty-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:	156
US Patents:	4
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
Patent Applications:	783
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:

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

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	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	RE46417		Y	Y
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450-001	Jul 23, 2012		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	7,078,412
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	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/002706 Bretaris 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/002211 Eklira 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
Canada	2716724	NOUVEAU DOSAGE ET NOUVELLE FORMULATION (NOVEL DOSAGE AND FORMULATION)
Hungary	228594	NOVEL QUINUCLIDINE DERIVATIVES, PROCESS FOR THEIR PREPARATION AND MEDICINAL COMPOSITIONS CONTAINING THE SAME
Slovenia	1200431

Supplementary Protection Certificates for ACLIDINIUM BROMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	CA 2013 00002	Denmark

ACLIDINIUM BROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aclidinium Bromide

Introduction

Aclidinium bromide, a long-acting muscarinic antagonist (LAMA), has been a significant player in the treatment of chronic obstructive pulmonary disease (COPD) and other respiratory conditions. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key factors influencing its growth and projections.

Market Size and Projections

The aclidinium bromide market has shown promising growth. As of 2023, the market size was valued at approximately USD 20 million, and it is expected to reach USD 33 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7% from 2024 to 2031[1].

However, another report suggests a broader market valuation, indicating that the aclidinium bromide market size was around USD 600 million in 2023 and is projected to reach around USD 1.1 billion by 2032[4]. This discrepancy may be due to differences in market segmentation and geographical scope.

Market Segmentation

The aclidinium bromide market is segmented based on several factors:

• Type: This includes inhalation powder, inhaler, Dry Powder Inhaler (DPI), nebulizer solution, and aerosol. The DPI segment, particularly the TUDORZA® PRESSAIR® formulation, has been a key driver due to its ease of use and effectiveness[1][2].
• Application: The primary applications are for the treatment of COPD, bronchospasm, asthma, emphysema, and chronic bronchitis. COPD remains the dominant application due to the drug's efficacy in reducing exacerbations and improving patient outcomes[1][2].
• Geography: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth dynamics influenced by local healthcare policies, patient demographics, and market penetration of respiratory treatments[1].

Drivers of Market Growth

Several factors are driving the growth of the aclidinium bromide market:

• Increasing Incidence of Respiratory Conditions: The rising prevalence of COPD and other respiratory diseases is a major driver. COPD is a significant health concern, especially among the aging population, and aclidinium bromide's effectiveness in managing COPD symptoms is crucial[1][2].
• Advancements in Inhalation Devices: Improvements in inhalation treatment devices and formulations have enhanced patient compliance and treatment outcomes. The TUDORZA® PRESSAIR® inhaler, for example, has been praised for its user-friendly design and efficacy in reducing COPD exacerbations[2].
• Respiratory Health Awareness: Growing awareness about respiratory health issues and the importance of long-term management of COPD are also propelling market growth[1].

Regulatory Approvals and Updates

Regulatory approvals and updates play a critical role in the market trajectory of aclidinium bromide. For instance, the FDA approval of TUDORZA® PRESSAIR® to include data on the reduction of COPD exacerbations and hospitalizations, as well as safety data regarding major adverse cardiovascular events, has significantly boosted the drug's credibility and market position[2].

Competitive Landscape

The aclidinium bromide market is competitive, with several key players involved:

• AstraZeneca: A major player, especially with the TUDORZA® PRESSAIR® brand.
• Boehringer Ingelheim: Known for its strong presence in the respiratory market with other LAMA products like tiotropium bromide.
• Novartis, Teva Pharmaceuticals, Mylan, Sun Pharmaceutical, Lupin Pharmaceuticals, Cipla, Glenmark Pharmaceuticals, Hikma Pharmaceuticals, Sandoz, and Zydus Cadila: These companies also have a significant presence in the market, offering various formulations and brands of aclidinium bromide[1].

Financial Performance and Projections

The financial performance of aclidinium bromide is closely tied to its market size and growth projections. Here are some key financial highlights:

• Revenue Growth: The market is expected to grow from USD 20 million in 2023 to USD 33 million by 2031, indicating a steady revenue increase driven by increasing demand and improved market penetration[1].
• Market Valuation: The broader market valuation of around USD 600 million in 2023, projected to reach USD 1.1 billion by 2032, suggests significant financial potential for the drug[4].

Patient Compliance and Cost Considerations

Patient compliance is a crucial factor in the financial trajectory of aclidinium bromide. Programs like the Tudorza eVoucher, which allows commercially insured patients to pay as little as $0 per prescription, enhance patient compliance and contribute to the drug's financial success[5].

Challenges and Opportunities

Despite the positive growth trajectory, there are challenges and opportunities to consider:

• Cost of Drug Development: The high cost of developing respiratory drugs, estimated to be over $1.5 billion per approved drug, poses a significant challenge. However, reducing attrition rates during development could significantly lower these costs[3].
• Market Competition: The respiratory drug market is highly competitive, with several established and emerging players. Differentiating aclidinium bromide through clinical efficacy, patient compliance programs, and innovative delivery systems is essential[1][3].

Key Takeaways

• The aclidinium bromide market is growing, driven by increasing incidence of respiratory conditions and advancements in inhalation devices.
• Regulatory approvals and updates, such as the FDA approval for TUDORZA® PRESSAIR®, are critical for market growth.
• The competitive landscape is diverse, with several key players contributing to the market.
• Financial projections indicate steady revenue growth, with the market expected to reach USD 33 million by 2031.
• Patient compliance programs and cost considerations are vital for the drug's financial success.

FAQs

What is the primary use of aclidinium bromide?

Aclidinium bromide is primarily used for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) to reduce exacerbations and improve symptoms.

Which companies are major players in the aclidinium bromide market?

Major players include AstraZeneca, Boehringer Ingelheim, Novartis, Teva Pharmaceuticals, Mylan, Sun Pharmaceutical, Lupin Pharmaceuticals, Cipla, Glenmark Pharmaceuticals, Hikma Pharmaceuticals, Sandoz, and Zydus Cadila.

What are the key drivers of the aclidinium bromide market?

Key drivers include the increasing incidence of respiratory conditions, advancements in inhalation devices, and growing awareness about respiratory health.

What is the projected market size of aclidinium bromide by 2031?

The market size is expected to reach around USD 33 million by 2031, growing at a CAGR of 7% from 2024 to 2031[1].

How does the FDA approval impact the market for TUDORZA® PRESSAIR®?

The FDA approval to include data on the reduction of COPD exacerbations and hospitalizations, as well as safety data regarding major adverse cardiovascular events, has significantly boosted the drug's credibility and market position[2].

References

1. Market Research Intellect: "Aclidinium Bromide Market Size and Projections"
2. Biospace: "FDA Approves TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) Supplemental New Drug Application (sNDA)"
3. European Respiratory Journal: "Barriers to new drug development in respiratory disease"
4. Dataintelo: "Aclidinium Bromide Market Research Report 2032"
5. Tudorza: "Savings Information | TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder)"