ALUPENT Drug Patent Profile

When do Alupent patents expire, and when can generic versions of Alupent launch?

Alupent is a drug marketed by Boehringer Ingelheim and is included in five NDAs.

The generic ingredient in ALUPENT is metaproterenol sulfate. There are six drug master file entries for this compound. Additional details are available on the metaproterenol sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Alupent

A generic version of ALUPENT was approved as metaproterenol sulfate by CHARTWELL on July 22^nd, 1992.

Summary for ALUPENT

US Patents:	0
Applicants:	1
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	39
Patent Applications:	3,796
DailyMed Link:	ALUPENT at DailyMed

US Patents and Regulatory Information for ALUPENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	AEROSOL, METERED;INHALATION	016402-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	TABLET;ORAL	015874-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	SOLUTION;INHALATION	017659-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	SOLUTION;INHALATION	018761-002	Oct 10, 1986		DISCN	No	No
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	SOLUTION;INHALATION	018761-001	Jun 30, 1983		DISCN	No	No
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	TABLET;ORAL	015874-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Boehringer Ingelheim	ALUPENT	metaproterenol sulfate	SYRUP;ORAL	017571-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for ALUPENT

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

International Patents for ALUPENT

See the table below for patents covering ALUPENT around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	413863	Verfahren zur Herstellung neuer Aminoalkohole
Germany	1275069	1-(3', 5'-Dihydroxyphenyl)-1-hydroxy-2-isopropylaminoalkane und Verfahren zu ihrer Herstellung
Belgium	611502
France	922
Netherlands	120608
Sweden	310889
Switzerland	410009	Verfahren zur Herstellung neuer Aminoalkohole

ALUPENT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alupent (Metaproterenol Sulfate)

Introduction

Alupent, also known as metaproterenol sulfate, is a bronchodilator used to treat conditions such as asthma, bronchitis, and emphysema. Understanding the market dynamics and financial trajectory of Alupent involves analyzing various factors, including competition, regulatory environment, patient needs, and technological advancements.

Market Overview

The market for respiratory drugs, including bronchodilators like Alupent, is influenced by several key factors:

Prevalence of Respiratory Diseases

The increasing prevalence of respiratory diseases such as asthma and COPD drives the demand for effective treatment options. This trend is expected to continue, contributing to the growth of the market[4].

Competitive Landscape

The respiratory drug market is highly competitive, with multiple players offering various types of bronchodilators. The entry of generic versions of branded drugs can significantly impact the market dynamics, as seen in the generic drug industry where prices decline with the number of competitors, especially when there are eight or more competitors[1].

Generic Competition and Pricing

Generic versions of drugs like Alupent can alter the pricing landscape. Here are some key points:

Price Reduction with Competition

Studies have shown that generic drug prices fall as the number of competitors increases. For instance, prices for the initial generic monopolist can be 35% to 50% above long-run marginal costs, but these prices decline as more firms enter the market. Prices begin to approach long-run marginal cost when there are eight or more competitors[1].

Entry and Profits

More firms enter markets with greater expected rents, and the timing of entry is crucial. The uncertainty in FDA approval times and the sequential nature of entry decisions can affect the market share and profits of individual generic entrants[1].

Regulatory Environment

Regulatory changes and policies can significantly impact the market for drugs like Alupent:

FDA Approvals and Compliance

The FDA's approval process and compliance requirements can affect the availability and pricing of drugs. For example, the transition from CFC-based inhalers to non-CFC alternatives, as seen with Maxair Autohaler, can create temporary market disruptions and affect patient access to certain drugs[5].

Preferred Drug Programs

Programs like the New York State Medicaid Preferred Drug Program can influence the market share of specific drugs. These programs often favor cost-effective medications, which can shift market share from more expensive non-preferred drugs to preferred ones, leading to significant cost savings[2].

Technological Advancements

Advancements in drug delivery devices are transforming the market:

Digital Drug Delivery Devices

There is a growing trend towards digital inhalation devices, which are more patient-friendly and effective. These devices are expected to drive the COPD drug delivery devices market, with a CAGR of around 5% for digital devices compared to 3.8% for manual devices during the forecast period[4].

Patient-Centric Models

The focus on patient-centric models and the integration of new digital technologies are key drivers in the development of new drug delivery devices. This shift is expected to improve patient outcomes and enhance market growth[4].

Financial Trajectory

The financial performance of Alupent and similar drugs can be influenced by several factors:

Revenue and Profits

Generic revenues and profits are highly dependent on the number of competitors and the expected market size. As more firms enter the market, revenues grow initially but begin to fall after five to eight months as competition increases[1].

Cost Savings and Rebates

Programs that promote cost-effective medications can lead to significant savings. For example, the New York State Medicaid Preferred Drug Program reported gross savings of $82.5 million, primarily due to supplemental rebates and a shift to preferred drugs[2].

Regional Market Dynamics

The market dynamics for Alupent can vary by region:

North America and Europe

These regions are expected to remain prominent due to favorable regulatory policies, a focus on research and development, and growing investments in product innovation[4].

Asia Pacific

The Asia Pacific region is anticipated to witness the fastest CAGR growth due to increasing awareness about the benefits of digital COPD drug delivery devices[4].

Key Players and Market Strategies

Major pharmaceutical companies are actively involved in the development and marketing of respiratory drugs:

Product Development

Companies like Novartis AG, Teva Pharmaceutical Industries, and Merck & Co., Inc. are enhancing the designs of conventional drug delivery devices to improve patient outcomes. Acquiring small to mid-sized companies is a strategy to gain market share[4].

Challenges and Opportunities

Regulatory Challenges

Companies must navigate regulatory changes, such as the transition from CFC-based inhalers, to maintain market presence[5].

Technological Opportunities

The integration of digital technologies in drug delivery devices presents significant opportunities for growth and improved patient outcomes[4].

Key Takeaways

• The market for Alupent is influenced by generic competition, regulatory changes, and technological advancements.
• Prices decline with increased competition, especially when there are eight or more competitors.
• Regulatory policies and preferred drug programs can significantly impact market share and cost savings.
• Technological advancements in drug delivery devices are driving market growth.
• Regional dynamics vary, with North America and Europe leading in innovation and the Asia Pacific region showing rapid growth.

FAQs

Q: How does generic competition affect the pricing of Alupent? A: Generic competition leads to a reduction in prices as the number of competitors increases. Prices approach long-run marginal cost when there are eight or more competitors[1].

Q: What role do regulatory policies play in the market for Alupent? A: Regulatory policies, such as FDA approvals and compliance requirements, can affect the availability and pricing of drugs. Policies like the transition from CFC-based inhalers can create temporary market disruptions[5].

Q: How are technological advancements impacting the market for respiratory drugs? A: Technological advancements, particularly in digital drug delivery devices, are improving patient outcomes and driving market growth. These devices are more patient-friendly and effective[4].

Q: What are the key regions driving the growth of the COPD drug delivery devices market? A: North America and Europe are prominent regions due to favorable regulatory policies and investments in innovation. The Asia Pacific region is expected to witness the fastest CAGR growth[4].

Q: How do preferred drug programs influence the market for Alupent? A: Preferred drug programs can shift market share from more expensive non-preferred drugs to cost-effective preferred drugs, leading to significant cost savings[2].

Cited Sources:

1. Federal Trade Commission. Generic Drug Industry Dynamics. February 2002.
2. New York State Department of Health. New York State Medicaid Preferred Drug Program Annual Report to the Legislature. 2006-07.
3. RxList. Alupent (Metaproterenol Sulfate): Side Effects, Uses.
4. Transparency Market Research. COPD Drug Delivery Devices Market by Product, Type and Forecast.
5. Obama White House Archives. Meeting Record. September 10, 2007.