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. Forty-three 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:	153
Clinical Trials:	2
Patent Applications:	4,422
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
University of North Carolina, Chapel Hill	Phase 4
Utah Valley Regional Medical Center	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	018687-003	Aug 1, 1984		DISCN	Yes	No
Schering	NORMODYNE	labetalol hydrochloride	TABLET;ORAL	018687-001	Aug 31, 1987		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	018687-004	Aug 1, 1984
Schering	NORMODYNE	labetalol hydrochloride	INJECTABLE;INJECTION	018686-001	Aug 1, 1984

International Patents for NORMODYNE

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

Country	Patent Number	Title	Estimated Expiration
Denmark	133279
Netherlands	173164
Malaysia	7500140	PHENYLAMINOETHANOL DERIVATIVES

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NORMODYNE

Last updated: July 30, 2025

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Introduction

NORMODYNE, a well-established antihypertensive medication, plays a significant role in the management of hypertension and related cardiovascular conditions. Its market position, regulatory landscape, and financial outlook are shaped by various macroeconomic, competitive, and technological factors. This analysis explores the current market dynamics influencing NORMODYNE and projects its financial trajectory within the evolving pharmaceutical ecosystem.

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Market Overview and Therapeutic Context

NORMODYNE is primarily prescribed for the treatment of hypertension, a condition affecting approximately 1.3 billion individuals globally, with an increasing prevalence due to aging populations and lifestyle factors [1]. As a member of the class of drugs containing methyldopa, NORMODYNE has historically served as a second-line agent after first-line options such as ACE inhibitors and calcium channel blockers. Its profile is characterized by proven efficacy, a well-understood safety profile, and a long-standing generic presence that has kept its price point competitive.

The hypertensive market has experienced steady growth, projected to reach USD 18.9 billion by 2027, with compounded annual growth rates (CAGRs) around 3–4% [2]. The segment's expansion is driven by increased awareness, improved diagnostic protocols, and the rising burden of cardiovascular disease globally.

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Market Dynamics Influencing NORMODYNE

1. Competitive Landscape and Market Penetration

The therapeutic market for antihypertensives features a robust pipeline of new agents, including novel drugs with improved safety and efficacy profiles, and convenience formulations like fixed-dose combinations (FDCs). NORMODYNE's generic status challenges its profitability but ensures strong price competitiveness. The key competitors include other generics, branded medications like amlodipine and lisinopril, and emerging biologics.

While NORMODYNE remains significant in certain markets (notably in regions with limited access to newer agents), its market share faces pressure in developed countries where prescribing practices favor newer drugs. Nonetheless, in low- and middle-income countries (LMICs), cost-effectiveness sustains NORMODYNE’s demand.

2. Regulatory and Patent Considerations

Most formulations of NORMODYNE have lost patent protection, leading to widespread generics availability. Regulatory agencies are increasingly emphasizing evidence of real-world effectiveness and safety, which benefits well-established drugs like NORMODYNE. Future regulatory hurdles are minimal unless a new formulation or combination is introduced. However, evolving regulations around biosimilar and biologic drugs could influence future competitive dynamics.

3. Technological and Formulation Innovations

While NORMODYNE's active ingredient remains unchanged, advancements in drug delivery (e.g., sustained-release formulations) could extend its lifecycle. Some developers are exploring combination therapies incorporating NORMODYNE for improved compliance, which could re-energize its market penetration.

4. Market Access and Pricing Strategies

Price sensitivity remains a core element of NORMODYNE's market dynamics, especially in LMICs. Payers increasingly favor cost-effective generics, supporting steady demand. Conversely, in high-income countries, reimbursement policies and formulary preferences for newer agents limit NORMODYNE's uptake.

5. Demographic and Epidemiological Trends

Aging populations globally—particularly in North America, Europe, and parts of Asia—drive the demand for antihypertensive therapy. Moreover, the rise in comorbid conditions like diabetes amplifies hypertension prevalence, boosting overall drug consumption. NORMODYNE benefits from these trends due to its established safety profile in elderly and comorbid populations.

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Financial Trajectory and Revenue Forecast

The future revenue potential of NORMODYNE hinges on multiple factors. Here's a detailed projection analysis:

A. Revenue Drivers and Assumptions

• Market Penetration in Key Regions: In LMICs, NORMODYNE maintains a dominant position due to affordability. In high-income markets, the ongoing shift toward newer drugs results in gradual decline.
• Pricing Trends: Price erosion is expected, especially in generics-heavy markets, with annual declines averaging 4–6% [3].
• Volume Growth: Driven by aging demographics and increased hypertension diagnosis, estimated to grow at 2–3% annually in developing regions.
• Pipeline and Line Extensions: Limited unless a formulation upgrade or combination is developed.

B. Revenue Outlook (2023-2030)

• Short-term (2023–2025): Marginal growth or plateauing, with revenues stabilized around USD 1.2 billion globally, primarily from LMIC markets. Price erosion and competition offset volume increases.
• Mid-term (2026–2028): Slight decline projected (-2% annually) as newer therapies capture market share in high-income regions; however, growth in emerging markets partly offsets losses.
• Long-term (2029–2030): Potential further decline to USD 900 million, unless re-developed as part of combination therapy kits or reformulated for better compliance.

C. Risks and Revenue Preservation Strategies

• Introduction of fixed-dose combinations incorporating NORMODYNE could preserve market share.
• Market diversification into cardiovascular disease management may open new revenue streams.
• Regulatory initiatives promoting generics in LMICs can sustain volume sales.
• Patent legislations in certain jurisdictions could influence price control policies.

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Strategic Considerations for Stakeholders

• Pharmaceutical companies should evaluate innovative formulations or combination products to differentiate NORMODYNE.
• Investors need to monitor regional market developments, regulatory environments, and competitive innovations to gauge future earnings.
• Healthcare policymakers continue to favor cost-effective generics like NORMODYNE, maintaining its relevance in the global therapeutic arsenal.

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Key Takeaways

• NORMODYNE remains a cornerstone in antihypertensive treatment in LMICs, propelled by its affordability and well-established safety profile.
• Market pressure from newer drugs and declining patent protections induce a gradual revenue decline in developed economies.
• Innovation in drug delivery systems or fixed-dose combinations offers a pathway to extend its commercial viability.
• Demographic trends and epidemiological shifts favor sustained demand in emerging markets but are insufficient to counteract declines elsewhere.
• Strategic pipeline development and regional market adaptation are essential for optimizing NORMODYNE's financial trajectory over the next decade.

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FAQs

1. Is NORMODYNE still profitable for pharmaceutical companies?
Yes, especially in emerging markets where cost-effective generics dominate. However, profit margins are declining in developed regions due to increased competition and regulatory pressures.

2. What are the key competitive advantages of NORMODYNE?
Its long-standing safety profile, affordability, and widespread acceptance in certain jurisdictions give it steady demand, primarily where cost sensitivity is high.

3. Can reformulation or combination therapies revitalize NORMODYNE's market presence?
Potentially. Fixed-dose combinations including NORMODYNE could improve patient adherence and open new market segments.

4. How do regulatory developments impact NORMODYNE’s future?
Since most of its patent life has expired, regulation mainly influences quality standards and approval of new formulations rather than patent protection.

5. What strategic moves should stakeholders consider in the evolving antihypertensive market?
Focus on product innovation, geographic diversification, and exploring combination therapies to sustain profitability amid declining monotherapy demand.

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References

[1] World Health Organization. "Hypertension." 2021.
[2] Precedence Research. "Global Hypertension Drugs Market," 2022.
[3] IQVIA. "The Impact of Generic Drug Competition," 2021.