Metaproterenol sulfate - Generic Drug Details

What are the generic sources for metaproterenol sulfate and what is the scope of freedom to operate?

Metaproterenol sulfate is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Apotex Inc, Astrazeneca, DEY, Mylan Speciality Lp, Nephron, Wockhardt, Muro, Chartwell, Cosette, G And W Labs Inc, Morton Grove, Am Therap, Heritage Pharma, Strides Pharma, Usl Pharma, and Watson Labs, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for metaproterenol sulfate.

Summary for metaproterenol sulfate

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	36
Drug Master File Entries:	5
Raw Ingredient (Bulk) Api Vendors:	58
Patent Applications:	2,557
What excipients (inactive ingredients) are in metaproterenol sulfate?	metaproterenol sulfate excipients list
DailyMed Link:	metaproterenol sulfate at DailyMed

Medical Subject Heading (MeSH) Categories for metaproterenol sulfate

Adrenergic beta-2 Receptor Agonists

Bronchodilator Agents

Sympathomimetics

Tocolytic Agents

US Patents and Regulatory Information for metaproterenol sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nephron	METAPROTERENOL SULFATE	metaproterenol sulfate	SOLUTION;INHALATION	071726-001	Jul 14, 1988		DISCN	No	No
Nephron	METAPROTERENOL SULFATE	metaproterenol sulfate	SOLUTION;INHALATION	071855-001	Jul 14, 1988		DISCN	No	No
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	SOLUTION;INHALATION	017659-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Apotex Inc	METAPROTERENOL SULFATE	metaproterenol sulfate	SYRUP;ORAL	075235-001	Jan 27, 2000		DISCN	No	No
Mylan Speciality Lp	METAPROTERENOL SULFATE	metaproterenol sulfate	SOLUTION;INHALATION	070804-001	Aug 17, 1987		DISCN	No	No
Wockhardt	METAPROTERENOL SULFATE	metaproterenol sulfate	SYRUP;ORAL	074702-001	Mar 24, 1997		DISCN	No	No
Wockhardt	METAPROTERENOL SULFATE	metaproterenol sulfate	SOLUTION;INHALATION	072190-001	Jun 7, 1988		DISCN	No	No

Expired US Patents for metaproterenol sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	TABLET;ORAL	015874-002	Approved Prior to Jan 1, 1982
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	AEROSOL, METERED;INHALATION	016402-001	Approved Prior to Jan 1, 1982
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	TABLET;ORAL	015874-001	Approved Prior to Jan 1, 1982
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	SYRUP;ORAL	017571-001	Approved Prior to Jan 1, 1982
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	SOLUTION;INHALATION	017659-001	Approved Prior to Jan 1, 1982
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	SOLUTION;INHALATION	018761-001	Jun 30, 1983

Metaproterenol sulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metaproterenol Sulfate

Introduction to Metaproterenol Sulfate

Metaproterenol sulfate is an oral bronchodilator used primarily for the treatment of bronchial asthma and reversible bronchospasm associated with bronchitis and emphysema. It belongs to the class of adrenergic bronchodilators, acting by stimulating beta adrenergic receptors to relax bronchial smooth muscle and inhibit the release of mediators of immediate hypersensitivity[1].

Market Size and Growth

The global market for asthma drugs, which includes metaproterenol sulfate, is experiencing significant growth. As of 2023, the U.S. asthma drugs market was valued at USD 8.95 billion and is projected to surpass USD 14.75 billion by 2033, with a Compound Annual Growth Rate (CAGR) of 5.12% over the forecast period[3].

Drivers of Market Growth

Rising Prevalence of Asthma

The increasing prevalence of asthma is a major driver of the market growth. Asthma affects approximately 25 million individuals in the United States, contributing to a substantial healthcare burden. The annual cost of asthma in the U.S. is estimated at around $56 billion, with direct costs primarily stemming from hospital stays and indirect costs including lost pay due to sickness or death[3].

Advancements in Treatment

Recent advancements in asthma treatment, such as the approval of new drugs like Airsupra and TEZSPIRE, are also driving market growth. These new treatments have shown significant efficacy in managing asthma, particularly in adult patients, and are expected to further solidify the market position of asthma drugs[3].

Segmentation of the Market

Adult, Pediatric, and Adolescent Segments

The U.S. asthma drugs market is segmented into pediatric, adult, and adolescent segments. The adult segment is currently the dominant force and is expected to maintain its market leadership throughout the forecast period. The pediatric segment, however, holds significant promise due to the need for personalized medication plans and the effectiveness of inhaled corticosteroids in reducing airway inflammation in children[3].

Financial Trajectory

Revenue Projections

The global asthma drugs market, which includes metaproterenol sulfate, is projected to grow from USD 25.69 billion in 2024 to USD 40.17 billion by 2033, with a CAGR of 5.09% over the forecast period. North America, led by the U.S., holds the highest market share, accounting for 49.56% of the global market in 2023[3].

Cost and Access

Despite the growing market, financial barriers remain a significant challenge. The high cost of asthma treatment, including medications and specialist visits, restricts access to care, particularly for low-income individuals. Public sector initiatives and programs like Medicaid and the Children’s Health Insurance Plan play a crucial role in mitigating these costs and improving patient outcomes[3].

Competitive Landscape

New Drug Approvals

The competitive landscape is dynamic, with recent approvals of new drugs such as Airsupra and TEZSPIRE. These drugs have demonstrated superior efficacy compared to traditional treatments like albuterol, further solidifying their market position. For instance, Airsupra has shown a 28% reduction in the risk of severe asthma attacks in adult patients[3].

Generic and Branded Options

Metaproterenol sulfate, being a generic drug, faces competition from both branded and generic alternatives. However, its established efficacy and safety profile, as demonstrated in clinical trials, help it maintain a significant market presence[1][2].

Clinical Efficacy and Safety

Pulmonary Function Improvements

Clinical studies have consistently shown that metaproterenol sulfate improves pulmonary function in patients with asthma. For example, a study in asthmatic children demonstrated statistically significant improvements in forced expiratory volume, peak expiratory flow rate, and other pulmonary function tests compared to placebo[2].

Side Effects and Safety Concerns

While metaproterenol sulfate is generally well-tolerated, it can cause side effects typical of beta-sympathomimetic agents, such as tachycardia and blood pressure changes. There are also concerns regarding teratogenic and embryotoxic effects in animal studies, although the significance of these findings in humans is unknown[1].

Regulatory Environment

FDA Approvals and Guidelines

The regulatory environment plays a crucial role in the market dynamics of asthma drugs. Recent FDA approvals for new treatments and the acceptance of New Drug Applications (NDAs) for drugs like Ensifentrine highlight the ongoing regulatory support for innovative asthma treatments[3].

Key Takeaways

• The U.S. asthma drugs market, including metaproterenol sulfate, is projected to grow significantly, driven by the rising prevalence of asthma and advancements in treatment.
• The adult segment dominates the market, but the pediatric segment holds promise due to personalized care and effective medication strategies.
• Financial barriers, including high treatment costs, remain a challenge, but public sector initiatives help mitigate these costs.
• Metaproterenol sulfate maintains a significant market presence due to its established efficacy and safety profile.

Frequently Asked Questions

1. What is metaproterenol sulfate used for? Metaproterenol sulfate is used as a bronchodilator for the treatment of bronchial asthma and reversible bronchospasm associated with bronchitis and emphysema[1].

2. How does metaproterenol sulfate work? Metaproterenol sulfate works by stimulating beta adrenergic receptors, leading to the relaxation of bronchial smooth muscle and inhibition of the release of mediators of immediate hypersensitivity[1].

3. What are the common side effects of metaproterenol sulfate? Common side effects include tachycardia and blood pressure changes, similar to those noted with other sympathomimetic agents[1].

4. Is metaproterenol sulfate safe during pregnancy? Metaproterenol sulfate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as it has shown teratogenic and embryotoxic effects in animal studies[1].

5. How is the market for asthma drugs expected to grow? The U.S. asthma drugs market is projected to grow from USD 8.95 billion in 2023 to USD 14.75 billion by 2033, with a CAGR of 5.12% over the forecast period[3].

Cited Sources

1. Drugs.com: Metaproterenol Tablets: Package Insert / Prescribing Info.
2. JAMA: Long-Term Metaproterenol Therapy in Asthmatic Children.
3. Biospace: U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033.