LOPRESSOR HCT Drug Patent Profile

When do Lopressor Hct patents expire, and what generic alternatives are available?

Lopressor Hct is a drug marketed by Validus Pharms and is included in one NDA.

The generic ingredient in LOPRESSOR HCT is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.

Summary for LOPRESSOR HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	26
Drug Prices:	Drug price information for LOPRESSOR HCT
What excipients (inactive ingredients) are in LOPRESSOR HCT?	LOPRESSOR HCT excipients list
DailyMed Link:	LOPRESSOR HCT at DailyMed

See drug prices for LOPRESSOR HCT

Recent Clinical Trials for LOPRESSOR HCT

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

Sponsor	Phase
University of Wisconsin, Madison	Phase 2
National Center for Advancing Translational Science (NCATS)	Phase 2
Corcept Therapeutics	Phase 1

See all LOPRESSOR HCT clinical trials

Pharmacology for LOPRESSOR HCT

Drug Class	Thiazide Diuretic beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Increased Diuresis

US Patents and Regulatory Information for LOPRESSOR HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	AB	RX	Yes	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984		DISCN	Yes	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984		DISCN	Yes	No

Expired US Patents for LOPRESSOR HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	3,876,802
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	3,876,802
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	3,998,790

International Patents for LOPRESSOR HCT

See the table below for patents covering LOPRESSOR HCT around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	2106209
Switzerland	578507
Austria	317181

Supplementary Protection Certificates for LOPRESSOR HCT

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

LOPRESSOR HCT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LOPRESSOR HCT

Introduction to LOPRESSOR HCT

LOPRESSOR HCT is a combination tablet that includes metoprolol tartrate, a beta-adrenergic receptor blocker, and hydrochlorothiazide (HCTZ), a thiazide diuretic. It is primarily indicated for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and non-fatal cardiovascular events such as strokes and myocardial infarctions[2][4].

Market Size and Growth

The global metoprolol tartrate market, which includes LOPRESSOR HCT, is projected to experience significant growth over the forecast period. Here are some key financial metrics:

• The global metoprolol tartrate market was valued at approximately $6,101.4 million in 2022 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.3% from 2022 to 2030, reaching a projected value of $7,931.7 million by 2030[3].
• Another report estimates that the metoprolol tartrate market will reach $868.3 million by 2027, growing at a CAGR of 5.2% during the forecast period 2022-2027[1].

Market Drivers

Several factors are driving the growth of the LOPRESSOR HCT market:

• Increasing Prevalence of Hypertension: The rising prevalence of hypertension globally is a significant driver. For instance, in the U.S., approximately 47.3% of the adult population, or around 116 million people, suffered from hypertension in 2019[3].
• Expanding Elderly Population: The growing elderly population, who are more prone to cardiovascular diseases, is expected to increase the demand for metoprolol tartrate[1].
• Product Launches and Innovations: Market players are launching new products and strengths, such as Mylan N.V's introduction of new tablet strengths, which is expected to drive market growth[3].
• COVID-19 Impact: The COVID-19 pandemic has also contributed to the growth, as research into the use of metoprolol tartrate for treating cardiovascular complications associated with COVID-19 has shown promising results[3].

Geographical Analysis

The market for LOPRESSOR HCT is geographically diverse, with different regions contributing significantly:

• North America: This region holds the largest market share, accounting for 36% of the overall market in 2021. The high prevalence of heart diseases and the presence of major pharmaceutical companies drive this dominance[1][3].
• Asia-Pacific: This region is expected to exhibit the fastest CAGR over the forecast period due to the increasing application of metoprolol tartrate for treating hypertension and angina[1].

Application and Usage

LOPRESSOR HCT is indicated for several critical applications:

• Hypertension: It is primarily used to treat high blood pressure, reducing the risk of fatal and non-fatal cardiovascular events such as strokes and myocardial infarctions[2][4].
• Angina: It is also used to treat chest pain (angina) and improve survival chances after a heart attack[3].
• Myocardial Infarction: The injectable form of metoprolol tartrate is used in the early stages of a heart attack to minimize the risk of death[1].

Dosage and Administration

The dosage of LOPRESSOR HCT typically involves:

• Metoprolol tartrate: 100 mg to 400 mg per day
• Hydrochlorothiazide: 12.5 mg to 50 mg per day The tablets are usually administered once daily, with or immediately following meals[2][4].

Challenges and Restraints

Despite the growth potential, the market faces several challenges:

• Side Effects: The rising side effects of metoprolol tartrate, such as bradycardia, hypotension, and electrolyte imbalances, are significant restraints[2].
• Government Regulations: Strict government regulations on the use and distribution of metoprolol tartrate also hamper market growth[1].
• Contraindications: LOPRESSOR HCT is contraindicated in patients with cardiogenic shock, decompensated heart failure, and certain other conditions, which limits its use[2].

Competitive Landscape

The market for LOPRESSOR HCT is highly competitive, with several key players:

• Novartis Pharmaceuticals
• AstraZeneca Pharma India Limited
• Teva Pharmaceutical Industries Ltd.
• Mylan N.V.
• Dr. Reddy’s Laboratories Ltd.
• Sun Pharmaceutical Industries Inc.
• Hikma Pharmaceuticals PLC
• Validus Pharmaceuticals LLC
• Alembic Pharmaceuticals Limited
• Aurobindo Pharma USA
• Sandoz Canada Inc.
• Apotex Inc.
• Ipca Laboratories Ltd
• Rubicon Research Pvt. Ltd.[3].

Key Takeaways

• The global metoprolol tartrate market, including LOPRESSOR HCT, is expected to grow significantly due to increasing hypertension prevalence and product innovations.
• North America dominates the market, but the Asia-Pacific region is expected to grow at the fastest CAGR.
• The market faces challenges from side effects and government regulations.
• Major pharmaceutical companies are actively involved in product launches and expansions.

FAQs

1. What is LOPRESSOR HCT used for? LOPRESSOR HCT is used for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and non-fatal cardiovascular events such as strokes and myocardial infarctions[2][4].

2. What are the common dosages of LOPRESSOR HCT? The usual dosage involves metoprolol tartrate 100 mg to 400 mg per day and hydrochlorothiazide 12.5 mg to 50 mg per day, administered once daily[2][4].

3. What are the major side effects of LOPRESSOR HCT? Common side effects include bradycardia, hypotension, electrolyte imbalances, and potential exacerbation of conditions like diabetes and gout[2].

4. Which region dominates the metoprolol tartrate market? North America holds the largest market share due to the high prevalence of heart diseases in the region[1][3].

5. How is the COVID-19 pandemic impacting the metoprolol tartrate market? The pandemic has driven research into the use of metoprolol tartrate for treating cardiovascular complications associated with COVID-19, contributing to market growth[3].

Cited Sources

1. IndustryARC: Metoprolol Tartrate Market Size Report, 2022-2027.
2. DailyMed: LOPRESSOR HCT - metoprolol tartrate and hydrochlorothiazide tablet.
3. Coherent Market Insights: Metoprolol Tartrate Market Size, Trends and Forecast to 2030.
4. FDA: LOPRESSOR HCT - metoprolol tartrate and hydrochlorothiazide tablets, for oral use.