TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for trandolapril; verapamil hydrochloride and what is the scope of freedom to operate?

Trandolapril; verapamil hydrochloride is the generic ingredient in two branded drugs marketed by Abbvie and Glenmark Pharms Ltd, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	5
DailyMed Link:	TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

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

Sponsor	Phase
Hospital Authority, Hong Kong	Phase 4
Assaf-Harofeh Medical Center
Agenzia Italiana del Farmaco	Phase 3

See all TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE clinical trials

Pharmacology for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Drug Class	Angiotensin Converting Enzyme Inhibitor Calcium Channel Blocker
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

C08DA	Phenylalkylamine derivatives
C08D	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CARDIAC EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TARKA	Extended-release Tablets	trandolapril; verapamil hydrochloride	1 mg/240 mg	020591	1	2008-02-20
TARKA	Extended-release Tablets	trandolapril; verapamil hydrochloride	2 mg/180 mg and 2 mg/240 mg	020591	1	2007-11-09
TARKA	Extended-release Tablets	trandolapril; verapamil hydrochloride	4 mg/ 240 mg	020591	1	2007-07-24

US Patents and Regulatory Information for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079135-001	May 26, 2010		RX	No	No
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-001	Oct 22, 1996		DISCN	Yes	No
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-004	Oct 22, 1996		DISCN	Yes	No
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-003	Oct 22, 1996		DISCN	Yes	No
Glenmark Pharms Ltd	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079135-004	Aug 30, 2010		RX	No	No
Glenmark Pharms Ltd	TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079135-002	May 26, 2010		RX	No	No

Expired US Patents for TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-002	Oct 22, 1996	4,933,361
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-003	Oct 22, 1996	4,933,361
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-004	Oct 22, 1996	5,721,244
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-002	Oct 22, 1996	5,721,244
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-004	Oct 22, 1996	4,933,361
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-001	Oct 22, 1996	5,721,244

TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trandolapril and Verapamil Hydrochloride

Introduction

Trandolapril and verapamil hydrochloride, combined in the drug TARKA, are widely used for the treatment of hypertension. This combination therapy has been a significant player in the cardiovascular drug market, influenced by various factors including regulatory approvals, clinical efficacy, and market competition.

Regulatory Approvals and Market Entry

In 2015, Glenmark Generics Inc., a subsidiary of Glenmark Pharmaceuticals, received approval from the US FDA to market trandolapril and verapamil hydrochloride extended-release tablets, known as TARKA. This approval marked a crucial milestone in the drug's market entry, allowing Glenmark to distribute the medication immediately in various strengths[1].

Clinical Efficacy and Safety

The combination of trandolapril, an ACE inhibitor, and verapamil hydrochloride, a calcium channel blocker, has been shown to have an additive antihypertensive effect. Clinical studies, such as the International Verapamil SR-Trandolapril Study (INVEST), have demonstrated that this combination is effective in reducing blood pressure and preventing cardiovascular outcomes in patients with hypertension and coronary artery disease[3][4].

Market Competition

TARKA competes in a crowded market for hypertension treatments. The drug's unique combination and slow-release formulation differentiate it from other antihypertensive medications. However, it faces competition from other fixed-dose combinations and individual components like verapamil and ACE inhibitors. The market dynamics are also influenced by generic versions of these drugs, which can impact pricing and market share[1].

Financial Performance

The financial trajectory of TARKA is tied to its market performance and sales. As of 2014, the annual sales of TARKA stood at approximately $23.5 million, according to IMS Health sales data. This figure indicates a modest but significant market presence. The approval for generic versions by companies like Glenmark can increase market accessibility and potentially boost sales, although it may also lead to price competition[1].

Pricing and Accessibility

The pricing of TARKA and its generic versions is a critical factor in its market dynamics. Generic approvals can lead to lower prices, making the drug more accessible to a wider patient population. For instance, Glenmark's generic version of TARKA is expected to be more affordable, which could increase its market share and overall sales volume[1].

Patient Demographics and Treatment Response

The efficacy of TARKA varies across different patient demographics. Studies have shown that the combination is effective across various age groups and genders, although there are differences in response rates among different racial groups. For example, African American patients may require higher doses to achieve optimal blood pressure control[3][4].

Pharmacokinetics and Dosage

The pharmacokinetics of TARKA are complex, with the bioavailability and peak concentrations of verapamil and trandolapril being influenced by factors such as age, renal function, and food intake. Elderly patients and those with renal impairment may require dosage adjustments to achieve optimal therapeutic effects without increasing the risk of adverse events[2].

Clinical Studies and Outcomes

Large-scale clinical studies like INVEST have provided valuable insights into the efficacy and safety of TARKA. These studies have shown that the combination of verapamil and trandolapril can achieve significant blood pressure reduction and is comparable to other antihypertensive strategies in preventing cardiovascular outcomes. The safety profile of TARKA has been found to be generally favorable, with common adverse events being headache and cough, which are well-known side effects of the individual components[3][4].

Regulatory and Compliance Aspects

Regulatory compliance is crucial for the continued market presence of TARKA. The drug has undergone extensive evaluation, including bioavailability and bioequivalence studies, to ensure its safety and efficacy. Regulatory bodies such as the European Medicines Agency (EMA) and the US FDA have provided guidelines and approvals that shape the drug's market trajectory[4].

Market Expansion and Future Prospects

The market for TARKA and its generic versions is expected to grow as the global prevalence of hypertension increases. Expanding into new markets, particularly in regions with growing healthcare needs, can provide opportunities for increased sales. Additionally, ongoing research and clinical trials may further establish the drug's efficacy and safety, potentially leading to broader adoption[3].

Key Takeaways

• Regulatory Approvals: FDA approval for generic versions has expanded market accessibility.
• Clinical Efficacy: The combination of trandolapril and verapamil hydrochloride has shown additive antihypertensive effects.
• Market Competition: Faces competition from other antihypertensive medications and generic versions.
• Financial Performance: Modest sales figures with potential for growth through generic versions.
• Pricing and Accessibility: Generic versions can make the drug more affordable and accessible.
• Patient Demographics: Efficacy varies across different patient demographics.
• Pharmacokinetics: Bioavailability and peak concentrations are influenced by several factors.
• Clinical Studies: Large-scale studies have demonstrated the drug's efficacy and safety.

FAQs

What is TARKA used for?

TARKA is used for the treatment of hypertension. It combines trandolapril, an ACE inhibitor, and verapamil hydrochloride, a calcium channel blocker, to achieve an additive antihypertensive effect[2].

How does TARKA compare to other antihypertensive medications?

TARKA has been shown to be as effective as other antihypertensive strategies in reducing blood pressure and preventing cardiovascular outcomes. Its unique combination and slow-release formulation differentiate it from other treatments[3][4].

What are the common side effects of TARKA?

Common side effects of TARKA include headache and cough, which are well-known side effects of the individual components, verapamil and trandolapril[4].

How does food intake affect the bioavailability of TARKA?

Food intake can decrease the bioavailability of verapamil but does not alter the bioavailability of trandolapril. Peak concentrations and the area under the curve (AUC) for verapamil decrease when taken with a high-fat meal[2].

Are there any specific dosage adjustments recommended for certain patient groups?

Yes, dosage adjustments are recommended for elderly patients and those with renal impairment to achieve optimal therapeutic effects without increasing the risk of adverse events[2].

Sources

1. Economic Times: Glenmark gets USFDA nod to sell generic blood pressure drug Tarka.
2. DailyMed: TARKA- trandolapril and verapamil hydrochloride tablet, film coated.
3. PubMed: Review of findings from the International Verapamil SR-Trandolapril Study (INVEST).
4. CBG-Meb: Public assessment report - trandolapril/verapamil hydrochloride.