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Last Updated: December 17, 2025

Trandolapril; verapamil hydrochloride - Generic Drug Details


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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
Recent Clinical Trials for trandolapril; verapamil hydrochloride

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

SponsorPhase
Hospital Authority, Hong KongPhase 4
Assaf-Harofeh Medical Center
Mario Negri Institute for Pharmacological ResearchPhase 3

See all trandolapril; verapamil hydrochloride clinical trials

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

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

Market Dynamics and Financial Trajectory for Trandolapril and Verapamil Hydrochloride

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for antihypertensive agents, particularly Trandolapril and Verapamil Hydrochloride, reflects evolving market dynamics driven by demographic shifts, technological advancements, and regulatory frameworks. These agents, integral to managing hypertension and cardiovascular conditions, occupy distinct yet intersecting niches within the broader cardiovascular therapeutics market.

Market Overview of Trandolapril

Pharmacology and Therapeutic Indications

Trandolapril is an angiotensin-converting enzyme (ACE) inhibitor, prescribed primarily for hypertension and heart failure management. Its efficacy in reducing cardiovascular morbidity and mortality underscores its therapeutic relevance. Trandolapril's market success hinges on its favorable pharmacokinetics, once-daily dosing, and proven clinical benefits, which position it as a preferred agent among ACE inhibitors.

Market Size and Growth Drivers

The global ACE inhibitor market, valued at approximately USD 4.7 billion in 2022, is projected to expand at a compound annual growth rate (CAGR) of around 4% through 2030. Trandolapril commands a substantial share within this segment, particularly in North America and Europe where hypertension prevalence remains high.

Key drivers include rising hypertension prevalence, increasing awareness, and expanding aging populations susceptible to cardiovascular conditions. Additionally, the crucial role of ACE inhibitors in combination therapies enhances market penetration. Patent expirations for similar agents and the availability of generic formulations further influence the market trajectory, with generics expected to drive volume growth and price pressures.

Regulatory and Pricing Dynamics

Regulatory landscapes in major markets are supportive, with agencies like the FDA approving Trandolapril for multiple indications. Price competition among generic manufacturers exerts downward pressure, although brand loyalty and physician prescribing patterns may sustain premium positioning temporarily.

Competitive Landscape

Major pharmaceutical companies such as Abbott (through its predecessor, Fortorge), Teva, and Sandoz produce Trandolapril generics. Innovation in drug delivery systems and combination therapies, such as Trandolapril with verapamil or other antihypertensives, influences market competitiveness.

Financial Trajectory and Forecast

In the medium term, sales of Trandolapril are projected to grow steadily, fueled by the rise in hypertension prevalence and generic adoption. Despite generic competition, brand-name formulations may sustain higher margins temporarily, especially in emerging markets where patent protections and regulatory barriers delay generics' entry.

Market Dynamics of Verapamil Hydrochloride

Pharmacology and Therapeutic Indications

Verapamil Hydrochloride is a calcium channel blocker (CCB), widely used in managing hypertension, angina pectoris, and certain arrhythmias. Its dual action on vascular smooth muscle and cardiac muscle renders it versatile. Verapamil’s novel formulations, extended-release (ER) variants, and combination products have fortified its market position.

Market Size and Growth Drivers

Globally, the calcium channel blocker market, estimated at USD 2.3 billion in 2022, is forecasted to grow with a CAGR of approximately 3.5% during 2023-2030. Verapamil, owing to its longstanding clinical use and established efficacy, commands a significant share.

Growth factors include increased screening for cardiovascular diseases, the expansion of aging populations, and the proliferation of combination therapies. The advent of ER formulations enhances patient compliance and therapeutic outcomes, further fortifying Verapamil’s market presence.

Regulatory Environment and Patent Trends

Verapamil is available as both branded and generic products worldwide. Patent expirations have led to widespread generic availability, intensifying price competition. Regulatory pathways favor approvals of simplified formulations, facilitating market expansion.

Competitive Strategies and Innovation

Manufacturers are focusing on developing sustained-release formulations, combination therapies (e.g., Verapamil with ACE inhibitors), and exploring novel delivery systems like transdermal patches. These innovations aim to overcome limitations associated with immediate-release formulations and expand patient adherence.

Financial Forecast and Market Trajectory

The long-term outlook remains cautiously optimistic; however, intense generic competition may suppress price premiums. Manufacturers are increasingly emphasizing marketing and differentiation through formulation innovations. The market is expected to grow moderately, driven by increased utilization in resistant hypertension and combination regimens.

Market Interplay and Integration

While Trandolapril and Verapamil traditionally serve different mechanistic subclasses, combination formulations and therapeutic regimens integrating both agents are common in contemporary practice. This convergence influences market dynamics, creating opportunities for combined drugs and strategic positioning by pharmaceutical companies.

The ascending preference for fixed-dose combinations (FDCs) reflects an industry response to patient compliance challenges. The market for such FDCs involving Trandolapril and Verapamil is projected to grow, augmenting revenues for incumbent firms and creating entry points for innovative combinations.

Regulatory and Economic Considerations

Patents and Exclusivity

Patent expirations in 2020s for some formulations of Verapamil and Trandolapril pave the way for increased generic competition, exerting downward pricing pressures. Nonetheless, strategic patent filings for novel formulations extend product lifecycle and market exclusivity.

Pricing Strategies

Price erosion due to generics remains a salient feature across both agents, impacting revenue streams. Companies adopt strategies such as value-added services, patient assistance programs, and focusing on formulations with enhanced therapeutic profiles to sustain profitability.

Healthcare Policy and Reimbursement

Reimbursement policies favor cost-effective therapies, influencing formulary decisions. The increasing adoption of generics in public and private sectors drives down costs, but also challenges brand retention.

Future Financial Trajectory

Forecasting suggests that global revenues for Trandolapril and Verapamil will experience incremental growth owing to rising demand rather than price increases. The key to sustained profitability lies in innovation, strategic partnership, and navigating regulatory landscapes efficiently.

Emerging markets, notably Asia-Pacific, present significant growth prospects owing to expanding healthcare infrastructure and rising cardiovascular disease burden. Tailored market entry strategies and affordability initiatives will be instrumental.

Key Takeaways

  • Market Growth: Both Trandolapril and Verapamil are positioned within expanding segments of antihypertensive therapy, with moderate CAGR projections driven by demographic trends.
  • Generic Competition: Patent expirations catalyze price erosion, necessitating differentiation through formulations and combination therapies.
  • Innovation Focus: Sustained-release formulations and fixed-dose combinations represent strategic avenues to maintain market share.
  • Regional Opportunities: Emerging markets offer substantial growth potential, supported by healthcare expansion and increasing disease prevalence.
  • Regulatory Navigation: Efficient regulatory approvals and patent strategies remain critical to maximizing profitability.

FAQs

1. How does patent expiration impact the market for Trandolapril and Verapamil?
Patent expirations lead to widespread generic manufacturing, significantly reducing product prices and compressing margins for branded versions. Companies must innovate or develop new formulations to maintain competitive advantage.

2. What are the primary factors influencing the growth of antihypertensive drugs globally?
Rising global hypertension prevalence, aging populations, improved diagnostic criteria, and emphasis on cardiovascular prevention strategies drive demand.

3. How do combination therapies involving Trandolapril and Verapamil influence market trends?
Fixed-dose combinations enhance patient compliance, increase market share, and open new therapeutic avenues, influencing both R&D investment and marketing strategies.

4. Which regions offer the most promising opportunities for future growth?
Emerging markets, especially Asia-Pacific and Latin America, present substantial growth opportunities due to expanding healthcare infrastructure and increasing disease burden.

5. What strategies can companies employ to sustain profitability amid rising generic competition?
Innovating with new formulations, securing regulatory exclusivity periods, developing combination drugs, and expanding into emerging markets are critical strategies.


Sources:

[1] MarketsandMarkets. "Antihypertensive Drugs Market by Type, Region - Global Forecast to 2030."
[2] IQVIA. "Global Cardiovascular Drugs Market Reports."
[3] U.S. FDA. "Approval and Patent Data for ACE Inhibitors."
[4] Grand View Research. "Calcium Channel Blockers Market Size & Trends."
[5] EvaluatePharma. "Pharmaceutical Market Outlook 2022-2030."

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