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
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-003	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	019046-003	Apr 6, 1987
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-001	Apr 6, 1987
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-004	Apr 6, 1987
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-003	Apr 6, 1987
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-002	Apr 6, 1987
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-002	Apr 6, 1987
Schering	NORMOZIDE	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019046-001	Apr 6, 1987

International Patents for NORMOZIDE

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

Country	Patent Number	Title	Estimated Expiration
Germany	1643224
Cyprus	806	PHENYLAMINOETHANOL DERIVATIVES
Belgium	752892
Cyprus	713	Phenylaminoethanol derivatives
Netherlands	162897
Spain	381534
South Africa	7004414

Supplementary Protection Certificates for NORMOZIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
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
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607

NORMOZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Normozide

Introduction

Normozide, a brand name for the combination of various antihypertensive drugs, is part of a broader market segment that includes treatments for hypertension and related cardiovascular diseases. To understand the market dynamics and financial trajectory of Normozide, it is essential to delve into the broader context of the antihypertensive drug market.

Global Antihypertensive Drug Market Overview

The global market for antihypertensive drugs is driven by several key factors, including an increasing prevalence of hypertension, a growing senior population, and rising healthcare expenditures.

• Increasing Prevalence of Hypertension: Hypertension is a widespread condition that affects millions worldwide. According to the Centers for Disease Control and Prevention, approximately 75 million people in the United States alone have high blood pressure, driving the demand for antihypertensive medications like Normozide[1].

Market Size and Growth

The market for antihypertensive drugs, including those similar to Normozide, is substantial and growing.

• Telmisartan Market Example: The telmisartan market, which is part of the broader antihypertensive market, was valued at USD 3,567.30 million in 2023 and is expected to reach USD 4,661.27 million by 2032, growing at a CAGR of 3.4% during the forecast period (2024-2032)[1].

Regional Market Dynamics

The market for antihypertensive drugs like Normozide varies significantly across different regions.

North America

• Dominant Market Share: North America is expected to be the highest shareholder in the antihypertensive drug market, driven by an increase in hypertension patients, advanced healthcare facilities, and a surge in the deployment of anti-hypertensive drugs. The geriatric population in the U.S., projected to reach approximately 98 million by 2060, also contributes to this growth[1].

Asia Pacific

• High Growth Rate: The Asia Pacific region is expected to grow at a higher CAGR, driven by densely populated countries like China and India, an increase in healthcare expenditures, and rising awareness of antihypertensive treatments. Significant players in this region, such as Zydus Cadila and Sun Pharmaceutical Industries Ltd., contribute to the market expansion[1].

Key Drivers

Several factors drive the market for antihypertensive drugs like Normozide:

• Aging Population: The increasing senior population is more susceptible to chronic renal illnesses and hypertension, leading to higher demand for these medications[1].
• Sedentary Lifestyle: A sedentary lifestyle and associated health issues contribute to the growing need for antihypertensive treatments[1].
• Healthcare Spending: Rising healthcare expenditures and increased awareness about hypertension treatment fuel the demand for these drugs[1].

Challenges

Despite the growth drivers, the market faces several challenges:

• Medication Shortages: Shortages of essential medications can hinder market expansion and impact patient care[1].
• Regulatory Changes: Changes in healthcare policies, such as those introduced by the Inflation Reduction Act (IRA), can shift market dynamics and impact drug coverage and pricing[3].

Impact of Regulatory Changes

The IRA is set to significantly impact the pharmaceutical market, including antihypertensive drugs.

• Part D Market Dynamics: The IRA will shift liability for stakeholders, increase costs for Part D plans, and favor Medicare Advantage Prescription Drug Plans (MA-PDs) over standalone Prescription Drug Plans (PDPs). This could lead to enrollment shifts and potential disruptions for fee-for-service enrollees[3].

Competitive Landscape

The market for antihypertensive drugs is highly competitive, with several key players:

• Major Players: Companies like Zydus Cadila, Aurobindo Pharma, Cipla Inc., and Sun Pharmaceutical Industries Ltd. are active in this market, contributing to its expansion through new drug launches and increased geographic presence[1].

Financial Trajectory

The financial trajectory of the antihypertensive drug market, including Normozide, is positive but complex.

• Revenue Growth: The telmisartan market, for example, is expected to grow from USD 3,567.30 million in 2023 to USD 4,661.27 million by 2032, indicating a steady revenue growth trajectory[1].
• CAGR: A CAGR of 3.4% during the forecast period reflects a stable and growing market[1].

Conclusion

The market dynamics and financial trajectory for drugs like Normozide are influenced by a combination of factors including demographic changes, healthcare spending, and regulatory environments.

Key Takeaways

• Growing Demand: Increasing prevalence of hypertension and a growing senior population drive the demand for antihypertensive drugs.
• Regional Variations: North America and Asia Pacific are key regions with different growth rates and market drivers.
• Regulatory Impact: Changes in healthcare policies, such as the IRA, can significantly impact market dynamics.
• Competitive Market: The market is highly competitive with major players contributing to its expansion.

FAQs

What are the main drivers of the antihypertensive drug market?

The main drivers include an increasing senior population, sedentary lifestyle, and rising healthcare expenditures.

How does the IRA impact the Part D market?

The IRA shifts liability for stakeholders, increases costs for Part D plans, and favors MA-PDs over standalone PDPs, potentially leading to enrollment shifts and market instability.

Which regions are expected to dominate the antihypertensive drug market?

North America is expected to be the highest shareholder, while the Asia Pacific region is expected to grow at a higher CAGR.

What are the challenges faced by the antihypertensive drug market?

Medication shortages and regulatory changes are significant challenges.

Who are the major players in the antihypertensive drug market?

Companies like Zydus Cadila, Aurobindo Pharma, Cipla Inc., and Sun Pharmaceutical Industries Ltd. are major players.

Sources

1. Straits Research: Telmisartan Market Size, Share and Forecast to 2030
2. BMJ Open: Research reported in this publication
3. Avalere: How May the IRA Shift Part D Market Dynamics?
4. MarketResearch.biz: Diuretic Drugs Market Size, Share Trends, Analysis, Forecast 2032