NORMODYNE Drug Patent Profile

Which patents cover Normodyne, and when can generic versions of Normodyne launch?

Normodyne is a drug marketed by Schering and is included in two NDAs.

The generic ingredient in NORMODYNE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Normodyne

A generic version of NORMODYNE was approved as labetalol hydrochloride by HERITAGE PHARMA on August 3^rd, 1998.

Summary for NORMODYNE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	2
Patent Applications:	5,451
DailyMed Link:	NORMODYNE at DailyMed

Recent Clinical Trials for NORMODYNE

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

Sponsor	Phase
Nebraska Methodist Health System	Phase 4
Winthrop University Hospital	Phase 4
Baylor College of Medicine	Phase 4

See all NORMODYNE clinical trials

US Patents and Regulatory Information for NORMODYNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984		DISCN	Yes	No
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987		DISCN	Yes	No
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-002	Aug 1, 1984		DISCN	Yes	No
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984		DISCN	Yes	No
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-004	Aug 1, 1984		DISCN	Yes	No

Expired US Patents for NORMODYNE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-002	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-003	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-002	Aug 1, 1984

International Patents for NORMODYNE

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	806	PHENYLAMINOETHANOL DERIVATIVES
Denmark	133279
France	8010
Greece	34663	ΜΕΘΟΔΟΣ ΔΙΑ ΤΗΝ ΠΑΡΑΣΚΕΥΗΝ ΠΑΡΑΓΩΓΩΝ ΦΕΝΥΛΑΜΙΝΟΕΘΑΝΟΛΗΣ.
Israel	28643	1-PHENYL-2-AMINOETHANOL DERIVATIVES
Switzerland	592051
Switzerland	582647

Market Dynamics and Financial Trajectory for Beta Blockers: A Focus on Normodyne (Labetalol)

Introduction

Beta blockers, including Normodyne (Labetalol), are a class of drugs that have been widely used to manage various cardiovascular conditions, such as hypertension, angina, and heart failure. This article delves into the market dynamics and financial trajectory of beta blockers, with a specific focus on Normodyne.

Global Beta Blockers Market Overview

The global beta blockers market is experiencing steady growth, driven primarily by the increasing prevalence of cardiovascular diseases and the rising geriatric population. This market is projected to grow from $9.1 billion in 2022 to over $14.4 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 5.2% from 2023 to 2031[1].

Market Drivers

Several factors are driving the growth of the beta blockers market:

Increasing Prevalence of Cardiovascular Diseases

Cardiovascular diseases, such as hypertension, angina, and heart failure, are on the rise globally. Beta blockers are effective in managing these conditions, which has led to an increased demand for these drugs[1].

Rise in Geriatric Population

The geriatric population is more prone to cardiovascular diseases, and as this demographic grows, so does the demand for beta blockers. This segment held more than 65.0% of the market share in 2022, primarily due to the high incidence of cardiac diseases in older adults[1].

Research and Development

Pharmaceutical companies are investing heavily in research and development to introduce new beta blockers with improved efficacy, safety, and tolerability. This includes the development of combination therapies and novel drug delivery systems, which are expected to further boost market growth[1].

Regional Market Analysis

The beta blockers market is geographically diverse, with different regions contributing significantly to its growth:

North America

North America is expected to account for the largest share of the beta blockers market from 2023 to 2031. This is due to the well-established healthcare system and high awareness of cardiovascular diseases in the region[1].

Asia Pacific

The Asia Pacific region is anticipated to grow at a significant pace during the forecast period. Factors such as the growing geriatric population, increasing cases of cardiovascular diseases, and ongoing research and development of new formulations are driving this growth[1].

Europe

Europe also plays a crucial role in the beta blockers market, with significant investments in research and development and a well-established healthcare system contributing to market expansion[1].

Normodyne (Labetalol) Market Dynamics

Definition and Use

Normodyne, also known as Labetalol, is a non-selective beta blocker used primarily to treat severe high blood pressure (hypertension). It works by reducing the workload on the heart and arteries, thus lowering blood pressure[5].

Market Size and Growth

While specific financial data for Normodyne is not readily available, it is part of the broader beta blockers market. The Labetalol market, in particular, is expected to grow significantly, with North America accounting for the highest market share in terms of revenue. The Asia Pacific region is also expected to witness substantial growth due to the presence of key pharmaceutical companies in economies like Japan and China[4].

Competitive Landscape

The beta blockers market, including Normodyne, is highly competitive with several key players such as Mylan N.V., Novartis AG, Pfizer Inc., Abbott, and Teva Pharmaceutical Industries Ltd. These companies are engaged in continuous research and development to enhance their market share[1].

Financial Trajectory

Revenue Projections

The overall beta blockers market is projected to reach over $14.4 billion by 2031. While specific revenue projections for Normodyne are not available, it is expected to contribute significantly to this growth due to its efficacy in treating hypertension and other cardiovascular conditions[1].

Pricing and Cost Savings

The cost of beta blockers, including Normodyne, can vary significantly depending on the region and distribution channel. Initiatives such as the Medicare Drug Price Negotiation Program aim to reduce drug costs, which could impact the pricing strategy for these drugs. For example, negotiated prices under such programs can lead to significant savings for patients and healthcare systems[2].

Distribution Channels

The distribution of beta blockers like Normodyne occurs through various channels:

Hospital Pharmacies

Hospital pharmacies are a significant distribution channel for beta blockers, especially for acute conditions requiring immediate treatment[1].

Retail Pharmacies

Retail pharmacies also play a crucial role in the distribution of beta blockers, providing easy access to patients for chronic condition management[1].

Challenges and Opportunities

Regulatory Environment

Changes in regulatory policies, such as those related to drug pricing and negotiations, can impact the market dynamics of beta blockers. For instance, the Medicare Drug Price Negotiation Program can influence the pricing and profitability of these drugs[2].

New Drug Approvals and Patent Expirations

New drug approvals and patent expirations can significantly affect the market. The introduction of new drugs can increase competition, while patent expirations can lead to the entry of generic versions, potentially reducing the market share of branded drugs like Normodyne[3].

Key Takeaways

• The global beta blockers market is growing steadily due to the increasing prevalence of cardiovascular diseases and the rise in the geriatric population.
• Normodyne (Labetalol) is a key player in this market, used primarily for treating severe hypertension.
• The market is highly competitive with several major pharmaceutical companies involved.
• Regional growth varies, with North America and the Asia Pacific region showing significant potential.
• Regulatory changes and new drug approvals can impact market dynamics and financial trajectories.

FAQs

What is the primary use of Normodyne (Labetalol)?

Normodyne (Labetalol) is primarily used to treat severe high blood pressure (hypertension) by reducing the workload on the heart and arteries.

How is the global beta blockers market expected to grow?

The global beta blockers market is expected to grow from $9.1 billion in 2022 to over $14.4 billion by 2031, with a CAGR of 5.2% from 2023 to 2031.

Which regions are driving the growth of the beta blockers market?

North America and the Asia Pacific region are expected to drive significant growth in the beta blockers market due to factors such as a well-established healthcare system and increasing cases of cardiovascular diseases.

What are the key factors influencing the financial trajectory of beta blockers?

Key factors include the increasing prevalence of cardiovascular diseases, rise in the geriatric population, research and development activities, and regulatory changes such as drug price negotiations.

How does the competitive landscape of the beta blockers market impact Normodyne?

The competitive landscape is highly fragmented with several major players. Continuous research and development and the launch of new formulations and combination therapies are key strategies to maintain market share.

Sources

1. Transparency Market Research - Beta Blockers Market Size, Share, Growth, Industry Report - 2031
2. CMS - Medicare Drug Price Negotiation Program
3. PubMed - National trends in prescription drug expenditures and projections for 2024
4. Intellectual Market Insights - Labetalol Market Size, Growth Forecast- Industry Outlook to 2028
5. Mayo Clinic - Labetalol (intravenous route) - Mayo Clinic