ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - Generic Drug Details

What are the generic sources for albuterol sulfate; ipratropium bromide and what is the scope of patent protection?

Albuterol sulfate; ipratropium bromide is the generic ingredient in four branded drugs marketed by Boehringer Ingelheim, Aiping Pharm Inc, Apotex Inc, Cipla, Luoxin Aurovitas, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, Watson Labs Teva, and Norvium Bioscience, and is included in twelve NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate; ipratropium bromide has one hundred and eighteen patent family members in thirty-six countries.

Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

International Patents:	118
US Patents:	6
Tradenames:	4
Applicants:	11
NDAs:	12
Finished Product Suppliers / Packagers:	15
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
DailyMed Link:	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE at DailyMed

Recent Clinical Trials for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
James J. Peters Veterans Affairs Medical Center	Phase 2
University of Texas Southwestern Medical Center	Phase 4
Dey	Phase 3

See all ALBUTEROL SULFATE; IPRATROPIUM BROMIDE clinical trials

Generic filers with tentative approvals for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.083% BASE;0.017%	SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Drug Class	Anticholinergic beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

R01AX	Other nasal preparations
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMBIVENT RESPIMAT	Inhalation Aerosol	albuterol sulfate; ipratropium bromide	100 mcg/20 mcg per actuation	021747	1	2023-03-30

US Patents and Regulatory Information for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes			Y
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes			Y
Cipla	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	077559-001	Dec 31, 2007	AN	RX	No	No
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes			Y

Expired US Patents for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011

International Patents for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
Germany	102006022002	Zerstäuber und Verfahren zur Zerstäubung von Fluid
Hong Kong	1093175	MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION, SPRAYER WITH THE NOZZLE AND MANUFACTURING METHOD OF THE NOZZLE
Cyprus	1111564
Montenegro	00797	SREDSTVO ZA DRŽANJE FLUIDNE KOMPONENTE (DEVICE FOR HOLDING A FLUIDIC COMPONENT)

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Albuterol Sulfate and Ipratropium Bromide

Introduction

Albuterol sulfate and ipratropium bromide, when combined, form a potent therapeutic agent used primarily in the treatment of respiratory diseases such as asthma, bronchial spasm, and chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics and financial trajectory of this drug combination.

Market Size and Growth

The global market for albuterol, a key component of this combination, was valued at USD 4,587.68 million in 2022 and is projected to reach USD 7,984.37 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.80% during the forecast period[3].

Drivers of Market Growth

Several factors drive the growth of the albuterol and ipratropium bromide market:

Increasing Prevalence of Respiratory Diseases

The rising global prevalence of respiratory diseases such as asthma, COPD, and bronchitis significantly contributes to the demand for albuterol and ipratropium bromide. These conditions require effective management, making these medications essential[3].

Growing Awareness and Diagnosis

Improved awareness and diagnostic techniques have led to earlier detection and better management of respiratory diseases. This increased diagnosis rate translates into higher demand for treatments like albuterol and ipratropium bromide[3].

Lifestyle Changes

Modern lifestyles, characterized by sedentary habits, poor dietary choices, and exposure to environmental pollutants, exacerbate respiratory diseases. This lifestyle-driven increase in respiratory conditions further boosts the market for these medications[3].

Government Initiatives and Healthcare Expenditure

Governments and healthcare organizations invest in awareness campaigns, research, and healthcare budgets for managing respiratory diseases. These initiatives enhance access to albuterol and ipratropium bromide, driving market growth[3].

Combination Therapies

Combination therapies that include albuterol and ipratropium bromide offer enhanced efficacy and convenience. These combinations are a significant opportunity for market expansion, as they simplify treatment regimens and provide better symptom management for patients[3].

Economic Evaluation and Cost Savings

Studies have shown that the use of ipratropium and albuterol combination therapies can lead to significant cost savings:

Cost Comparison

A retrospective claims analysis revealed that patients using the nebulized ipratropium and albuterol combination (DuoNeb) had lower total per-member-per-month (PMPM) expenditures compared to those using generic ipratropium and albuterol as separate agents. The study found that DuoNeb was associated with lower emergency department costs and fewer therapy interruptions[2].

Formulary Substitution

An automatic substitution of ipratropium-albuterol nebulization solution for metered-dose inhalers (MDIs) resulted in substantial cost savings. A three-month period saw a savings of $99,359 in drug costs, with an extrapolated full-year savings of $397,436. This substitution also reduced overall respiratory drug spending, despite additional costs for equipment and personnel[5].

Pharmacokinetics and Efficacy

The combination of ipratropium bromide and albuterol sulfate has been shown to be highly effective:

Dual Mechanism of Action

Ipratropium bromide inhibits muscarinic acetylcholine receptors (mAChRs), reducing mucus production and bronchoconstriction, while albuterol sulfate activates β2-adrenergic receptors, leading to bronchodilation and improved airflow[1].

Clinical Studies

Clinical studies have demonstrated that the combination of ipratropium bromide and albuterol sulfate results in significantly better changes in Forced Expiratory Volume in one second (FEV1) compared to using albuterol sulfate alone[4].

Market Segmentation

The market for albuterol and ipratropium bromide is segmented based on several factors:

By Diseases

The primary indications include asthma, COPD, and other respiratory conditions[3].

By Product Type

Different formulations such as inhalation solutions with varying concentrations are available[3].

By Type

Both generic and branded versions of the drug are available in the market[3].

By Dosage

The drug is administered through various routes, including inhalations and oral forms[3].

By End-Users

The primary end-users include hospitals, specialty clinics, and home healthcare settings[3].

Regulatory Framework

The regulatory environment plays a crucial role in the market dynamics of albuterol and ipratropium bromide:

Approval History

Ipratropium bromide and albuterol sulfate were first approved in France in January 1995 and are now approved in multiple countries globally[1].

Safety and Efficacy

The drug has successfully completed clinical trials and has been deemed safe and effective for use in patients with respiratory diseases[1].

Challenges and Considerations

While the market for albuterol and ipratropium bromide is growing, there are several challenges to consider:

Side Effects

As with all sympathomimetic amines, the drug should be used with caution in patients with cardiovascular disorders, convulsive disorders, hyperthyroidism, or diabetes mellitus[4].

Resource Utilization

The use of nebulized ipratropium and albuterol combination may require additional resources, such as vibrating mesh nebulizer technology and patient-specific kits, which can add to the overall cost[5].

Key Takeaways

• The global market for albuterol and ipratropium bromide is driven by the increasing prevalence of respiratory diseases, growing awareness and diagnosis, lifestyle changes, and government initiatives.
• Combination therapies offer enhanced efficacy and cost savings.
• The drug has a dual mechanism of action, targeting both mAChRs and β2-adrenergic receptors.
• Market segmentation includes various factors such as disease type, product type, and end-users.
• Regulatory approvals and safety profiles are crucial for market growth.

FAQs

What are the primary indications for ipratropium bromide and albuterol sulfate?

The primary indications include asthma, bronchial spasm, and chronic obstructive pulmonary disease (COPD)[1].

How does the combination of ipratropium bromide and albuterol sulfate work?

The combination targets both muscarinic acetylcholine receptors (mAChRs) and β2-adrenergic receptors, providing dual benefits in reducing mucus production and bronchoconstriction while promoting bronchodilation[1].

What are the economic benefits of using ipratropium and albuterol combination therapies?

Studies have shown that these combination therapies can result in significant cost savings, including lower emergency department costs and reduced overall respiratory drug spending[2][5].

What are the potential side effects of ipratropium bromide and albuterol sulfate?

The drug should be used with caution in patients with cardiovascular disorders, convulsive disorders, hyperthyroidism, or diabetes mellitus due to potential side effects such as increased heart rate and decreased serum potassium[4].

How is the market for albuterol and ipratropium bromide expected to grow?

The market is expected to grow at a CAGR of 6.80% from 2022 to 2030, reaching a value of USD 7,984.37 million by 2030[3].

Sources

1. Ipratropium bromide/Albuterol sulfate's R&D Progress - Synapse by Patsnap
2. Exploratory economic evaluation of patients with COPD on a nebulized ipratropium and albuterol combination product - PubMed
3. Global Albuterol Market – Industry Trends and Forecast to 2030 - Data Bridge Market Research
4. Ipratropium and Albuterol: Package Insert / Prescribing Info - Drugs.com
5. Financial effect of converting ipratropium-albuterol therapy from MDIs to nebulization solution - PubMed