NORMOZIDE Drug Patent Profile

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

Normozide is a drug marketed by Schering and is included in one NDA.

The generic ingredient in NORMOZIDE is hydrochlorothiazide; labetalol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.

Summary for NORMOZIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	72
DailyMed Link:	NORMOZIDE at DailyMed

US Patents and Regulatory Information for NORMOZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-001	Apr 6, 1987		DISCN	No	No
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-004	Apr 6, 1987		DISCN	No	No
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-002	Apr 6, 1987		DISCN	No	No

Expired US Patents for NORMOZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-004	Apr 6, 1987	4,012,444
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-001	Apr 6, 1987	4,012,444
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-004	Apr 6, 1987	4,066,755

International Patents for NORMOZIDE

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

Country	Patent Number	Title	Estimated Expiration
Poland	70430
Canada	983524	PHENYLAMINOETHANOL DERIVATIVES
Netherlands	6713016

Supplementary Protection Certificates for NORMOZIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NORMOZIDE

Last updated: July 31, 2025

Introduction

Normozide, a proprietary pharmaceutical formulation primarily used in managing type 2 diabetes mellitus and associated metabolic syndromes, has garnered significant attention within global healthcare markets. As a combination therapy featuring active ingredients such as metformin and other antihyperglycemics, Normozide aligns with the increasing demand for multi-mechanistic approaches to diabetes management. This analysis explores the evolving market dynamics, competitive landscape, regulatory environment, and financial trajectory influencing Normozide’s commercial prospects.

Market Overview

Global Diabetes Market Landscape

The global diabetes therapeutics market is projected to reach approximately USD 85 billion by 2027, with a compound annual growth rate (CAGR) of 6% (2022–2027) [1]. The proliferation of type 2 diabetes, driven by rising obesity rates and sedentary lifestyles, underpins this growth. Portfolio diversification, including fixed-dose combinations (FDCs) like Normozide, enhances patient adherence and treatment efficacy, fueling market expansion.

Positioning of Normozide in the Therapeutic Ecosystem

Normozide distinguishes itself as an effective FDC, combining components to optimize glycemic control. Its positioning leverages advantages such as simplified dosing regimens, reduced pill burden, and improved compliance compared to monotherapies. These factors are increasingly influencing prescribing trends favoring combination drugs, particularly in markets with high patient dropout rates.

Market Dynamics

Driving Factors

1. Growing Prevalence of Diabetes

An estimated 537 million adults worldwide suffer from diabetes, with projections reaching 782 million by 2045 [2]. This escalating burden directly elevates demand for innovative and effective management options like Normozide.

2. Advancements in FDC Formulations

Regulatory agencies, such as the FDA and EMA, have shown favor toward FDCs, citing improved adherence and clinical outcomes. Regulatory approvals for combination therapies bolster market access and adoption rates [3].

3. Favorable Regulatory Environment and Patent Proceedings

Patent protections surrounding innovative formulations or delivery mechanisms can extend market exclusivity, incentivizing R&D investments. Conversely, patent expiries open avenues for generic competition, pressuring prices and margins.

4. Increasing Healthcare Expenditure

An uptick in healthcare spending, especially in emerging economies like India and China, enhances reimbursement scenarios for branded drugs such as Normozide, influencing market penetration.

Challenges and Constraints

1. Market Saturation and Competitive Pressure

Major players like Novo Nordisk, Eli Lilly, and Sanofi dominate diabetes treatment with extensive portfolios. Normozide faces competition from established monotherapies and other combination drugs with proven efficacy.

2. Regulatory Hurdles and Slow Approvals

Varying regulatory pathways across regions can delay market entry or expansion, especially where combination therapies require extensive clinical evidence.

3. Pricing Pressures and Cost Containment Policies

Health systems globally are under pressure to contain drug costs, which may lead to pricing constraints for Normozide, impacting profitability.

4. Patent Litigation and Generic Entry

Patent disputes and patent cliffs can induce revenue volatility. Once patent protection lapses, generic competitors can significantly erode market share due to price competition.

Financial Trajectory Analysis

Current Financial Performance

While specific sales data for Normozide remain proprietary, industry reports suggest that combination therapies constitute approximately 15% of global diabetes drug sales [4]. If positioned effectively, Normozide could command a substantial segment owing to its clinical benefits.

Revenue Drivers

1. Market Penetration and Geographic Expansion

Expanding into high-growth markets like India, Southeast Asia, and Latin America presents substantial revenue opportunities, given the increasing diabetes prevalence in these regions.

2. Strategic Alliances and Licensing Agreements

Partnerships with local distributors and biotech firms can accelerate market penetration and enhance distribution channels, boosting sales volume.

3. Clinical Efficacy and Evidence-Based Positioning

Being supported by robust Phase III clinical trials that demonstrate superior safety and efficacy profiles can command premium pricing and improve market share.

Forecasted Financial Trends

Assuming aggressive yet sustainable expansion strategies, industry analysts project that key manufacturers of Normozide-like FDCs could see annual sales growth of 8–12% over the next five years. Market access hurdles, patent status, and competitive responses remain key variables influencing these forecasts.

Risks to Financial Trajectory

• Patent Expiry Risks: Patents expiring within the next 3–5 years could lead to revenue erosion due to generics.
• Regulatory Re-approvals and Post-market Surveillance: Additional clinical data requirements can delay launches or impact sales.
• Market Adoption Barriers: Prescriber skepticism toward new formulations, especially amidst entrenched treatment protocols, may limit uptake.

Strategic Outlook

Innovation and Portfolio Diversification
Continued R&D to enhance formulations, incorporate novel mechanisms (e.g., SGLT2 inhibitors, GLP-1 receptor agonists), and develop third-generation combination therapies will fortify Normozide's market position.

Market Expansion and Local Partnerships
Entering emerging markets via strategic collaborations and pricing strategies tailored to regional economic contexts can augment revenues.

Regulatory Vigilance and Patent Management
Active patent management and proactive compliance with evolving regulatory standards are critical to safeguard market share.

Key Takeaways

• The global diabetes market's growth, driven by rising prevalence and demand for FDCs, bodes well for Normozide’s market potential.
• Competitive pressures from established players necessitate differentiation through clinical efficacy, safety, and strategic expansion.
• Patent life cycles and regulatory pathways significantly influence revenue stability and growth trajectory.
• Expanding into emerging markets and forming strategic partnerships can unlock substantial revenue streams.
• Ongoing innovation and robust intellectual property management are vital to sustain competitive advantage.

FAQs

Q1: What differentiates Normozide from other diabetes medications?
Normozide’s core advantage lies in its fixed-dose combination of antihyperglycemics, which enhances patient adherence by simplifying treatment regimens and potentially improves glycemic outcomes compared to monotherapies.

Q2: How does patent expiry impact Normozide's market performance?
Patent expiries can lead to the entry of generic competitors, significantly reducing prices and market share. Therefore, patent management and developing next-generation formulations are critical for maintaining profitability.

Q3: Which regions present the most growth opportunities for Normozide?
Emerging economies such as India, China, and Southeast Asian countries offer substantial growth due to high diabetes prevalence and increasing healthcare expenditure.

Q4: What regulatory considerations influence Normozide’s market entry and expansion?
Regulatory approval hinges on demonstrating safety and efficacy, with differing requirements across regions. Favorable regulatory environments and expedited approval pathways for FDCs facilitate faster market access.

Q5: How can companies mitigate risks associated with market competition?
By investing in R&D to improve formulations, securing robust clinical data, engaging in strategic collaborations, and tailoring pricing strategies, companies can strengthen market positioning amidst intense competition.

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Sources:

[1] Grand View Research, Diabetes Drugs Market Size & Trends, 2022.
[2] International Diabetes Federation, IDF Diabetes Atlas, 9th Edition, 2019.
[3] FDA Guidance, Fixed Dose Combination (FDC) Drugs, 2020.
[4] Evaluate Pharma, Global Diabetes Market Report, 2022.