TRANDATE HCT Drug Patent Profile

When do Trandate Hct patents expire, and when can generic versions of Trandate Hct launch?

Trandate Hct is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in TRANDATE HCT 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 TRANDATE HCT

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	10
DailyMed Link:	TRANDATE HCT at DailyMed

Recent Clinical Trials for TRANDATE HCT

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

Sponsor	Phase
Loma Linda University	N/A
Nebraska Methodist Health System	Phase 4
Wright State University	Phase 4

See all TRANDATE HCT clinical trials

US Patents and Regulatory Information for TRANDATE HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-001	Apr 10, 1987		DISCN	No	No
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-004	Apr 10, 1987		DISCN	No	No
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-002	Apr 10, 1987		DISCN	No	No
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-003	Apr 10, 1987		DISCN	No	No

Expired US Patents for TRANDATE HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-003	Apr 10, 1987
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-001	Apr 10, 1987
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-004	Apr 10, 1987
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-003	Apr 10, 1987

International Patents for TRANDATE HCT

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

Country	Patent Number	Title	Estimated Expiration
Germany	1643224
Cyprus	806	PHENYLAMINOETHANOL DERIVATIVES
Belgium	752892
Cyprus	713	Phenylaminoethanol derivatives

Supplementary Protection Certificates for TRANDATE 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
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215

TRANDATE HCT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Trandate (Labetalol Hydrochloride)

Introduction

Labetalol hydrochloride, marketed under the brand name Trandate, is a significant medication in the management of hypertension and other cardiovascular conditions. This article delves into the market dynamics and financial trajectory of Trandate, highlighting its usage, competitive landscape, and economic implications.

Mechanism of Action and Indications

Labetalol hydrochloride is an alpha and beta adrenergic antagonist, which means it blocks both alpha-1 adrenergic and nonselective beta-adrenergic receptors. This dual action helps in relaxing and widening blood vessels, thereby reducing blood pressure and the workload on the heart[3][4][5].

Market Indications

Trandate is primarily indicated for the management of hypertension, either alone or in combination with other antihypertensive agents such as thiazide and loop diuretics. It is also used in the long-term management of angina and in treating hypertensive emergencies[1][3][5].

Competitive Landscape

The market for antihypertensive medications is highly competitive, with several pharmaceutical companies involved. Trandate, developed by GSK Plc, competes with other drugs targeting ADRA1 and β-adrenoceptors. Key competitors include products from Merck & Co., Inc., Sanofi, Novartis AG, and Organon & Co.[4].

Global Approval and Market Presence

Labetalol hydrochloride was first approved in Japan in October 1982 and later received FDA approval in the United States in August 1984. Since then, it has gained approval in multiple countries, making it a globally recognized medication for managing hypertension[3][4].

Pricing and Cost

The pricing of Trandate varies depending on the dosage form and the region. For instance, the cost of Trandate tablets can range from approximately $0.27 USD for a 100 mg tablet to $1.28 USD for a 300 mg tablet. The injectable form also varies in cost, around $1.25 USD per ml[3].

Side Effects and Patient Compliance

While Trandate is generally well-tolerated, it comes with a range of side effects, including common ones like headache, dizziness, nausea, and fatigue. Rare but serious side effects include heart block, hyperkalemia, and hepatotoxicity. These side effects can impact patient compliance and overall market demand[2][5].

Financial Performance

The financial performance of Trandate is influenced by several factors, including its efficacy, side effect profile, and the competitive landscape. As a well-established medication, Trandate has a stable market presence, although its sales may be affected by the introduction of newer antihypertensive drugs.

Revenue Trends

Historically, Trandate has generated significant revenue for GSK Plc. However, with the rise of generic versions and newer medications, the revenue from Trandate has seen a gradual decline. Despite this, it remains a crucial part of the antihypertensive market due to its proven efficacy and long-term use[4].

Market Share

Trandate holds a notable market share in the antihypertensive drug segment, although this share has been eroded somewhat by the entry of newer drugs and generic competitors. The drug's market share is also influenced by regional preferences and healthcare policies[4].

Research and Development

Continuous research and development are crucial in maintaining the market position of Trandate. GSK Plc and other pharmaceutical companies invest heavily in clinical trials and studies to enhance the drug's profile and explore new indications. This includes investigating its use in combination therapies and in managing other cardiovascular conditions[4].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of Trandate. Regulatory approvals, safety monitoring, and post-marketing surveillance are essential for maintaining the drug's market presence. Any changes in regulatory policies or the emergence of safety concerns can significantly impact the drug's financial trajectory[1][3].

Patient and Healthcare Provider Perspectives

Patient and healthcare provider perspectives are vital in shaping the market dynamics of Trandate. Factors such as ease of administration, side effect profile, and overall efficacy influence prescribing decisions. Positive feedback from both patients and healthcare providers can enhance the drug's market position, while negative experiences can lead to a decline in usage[2][5].

Future Outlook

The future outlook for Trandate is mixed. On one hand, its established efficacy and long-term use ensure a stable market presence. On the other hand, the increasing competition from newer antihypertensive drugs and generic versions poses a challenge. The drug's ability to adapt to changing market conditions and regulatory environments will be crucial in determining its long-term financial trajectory.

Emerging Trends

Emerging trends in the pharmaceutical industry, such as the development of combination therapies and personalized medicine, could impact Trandate's market position. The integration of digital health technologies and telemedicine may also influence how the drug is prescribed and monitored[4].

Potential for New Indications

There is ongoing research into the potential use of labetalol hydrochloride in other cardiovascular conditions. Expanding the drug's indications could help maintain or even increase its market share and revenue[3][4].

Key Takeaways

• Mechanism of Action: Trandate blocks both alpha-1 adrenergic and nonselective beta-adrenergic receptors.
• Indications: Primarily used for hypertension management, also used in angina and hypertensive emergencies.
• Competitive Landscape: Competes with other ADRA1 and β-adrenoceptors targeting drugs from major pharmaceutical companies.
• Global Approval: Approved in multiple countries since its initial approval in Japan in 1982.
• Pricing: Varies by dosage form and region.
• Side Effects: Common side effects include headache, dizziness, and nausea; rare but serious side effects include heart block and hepatotoxicity.
• Financial Performance: Stable but declining revenue due to generic competition and newer drugs.
• Future Outlook: Mixed, with potential for new indications and challenges from emerging trends and competition.

FAQs

What is the primary use of Trandate (labetalol hydrochloride)?

Trandate is primarily used to treat high blood pressure (hypertension) and can also be used in the long-term management of angina and in treating hypertensive emergencies.

Who developed Trandate?

Trandate was developed by GSK Plc, a renowned pharmaceutical company.

What are the common side effects of Trandate?

Common side effects include headache, dizziness, nausea, fatigue, and orthostatic hypotension.

Can Trandate be used in patients with asthma?

No, Trandate is contraindicated in patients with bronchial asthma and other obstructive airway diseases due to its beta-blocking activity.

How does the pricing of Trandate vary?

The pricing of Trandate varies by dosage form and region, with costs ranging from approximately $0.27 USD for a 100 mg tablet to $1.28 USD for a 300 mg tablet.

Sources

1. Trandate (labetalol hydrochloride) tablet label - FDA
2. Labetalol Hydrochloride - New Drug Approvals
3. Labetalol: Uses, Interactions, Mechanism of Action - DrugBank Online
4. An In-depth Analysis of Labetalol Hydrochloride's R&D Progress - Synapse Patsnap
5. Labetalol (oral route) - Mayo Clinic