Trandolapril - Generic Drug Details

What are the generic sources for trandolapril and what is the scope of patent protection?

Trandolapril is the generic ingredient in four branded drugs marketed by Abbvie, Anda Repository, Aurobindo Pharma, Chartwell Molecular, Epic Pharma, Epic Pharma Llc, Invagen Pharms, Lupin, Pharmobedient, Teva Pharms, Watson Labs, and Glenmark Pharms Ltd, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for trandolapril. Five suppliers are listed for this compound.

Summary for trandolapril

US Patents:	0
Tradenames:	4
Applicants:	12
NDAs:	13
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	18
Drug Prices:	Drug price trends for trandolapril
What excipients (inactive ingredients) are in trandolapril?	trandolapril excipients list
DailyMed Link:	trandolapril at DailyMed

See drug prices for trandolapril

Recent Clinical Trials for trandolapril

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

Sponsor	Phase
University of Nebraska	Phase 4
Hospital Authority, Hong Kong	Phase 4
Assaf-Harofeh Medical Center

See all trandolapril clinical trials

Pharmacology for trandolapril

Drug Class	Angiotensin Converting Enzyme Inhibitor
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for trandolapril

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MAVIK	Tablets	trandolapril	1 mg, 2 mg and 4 mg	020528	1	2004-10-04

US Patents and Regulatory Information for trandolapril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	TARKA	trandolapril; verapamil hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020591-001	Oct 22, 1996		DISCN	Yes	No
Anda Repository	TRANDOLAPRIL	trandolapril	TABLET;ORAL	078493-001	Aug 25, 2008		DISCN	No	No
Watson Labs	TRANDOLAPRIL	trandolapril	TABLET;ORAL	077805-001	Jun 12, 2007		DISCN	No	No

Expired US Patents for trandolapril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-002	Apr 26, 1996	4,933,361
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-003	Apr 26, 1996	5,744,496
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-001	Apr 26, 1996	4,233,361

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Trandolapril

Last updated: July 27, 2025

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Introduction

Trandolapril, an angiotensin-converting enzyme (ACE) inhibitor, is primarily prescribed for hypertension and heart failure management. Since its approval, it has played a vital role within cardiovascular therapeutic regimens. This report evaluates the market dynamics and financial trajectory of trandolapril, analyzing key factors influencing its commercialization, competitive landscape, regulatory considerations, and future growth potential.

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Pharmacological Profile and Clinical Relevance

Trandolapril, marketed under brand names such as Mavik (by Abbott Laboratories), belongs to the ACE inhibitor class, which prevents the conversion of angiotensin I to angiotensin II. This mechanism reduces vasoconstriction and decreases blood pressure, offering cardiovascular protection. Its clinical adoption hinges on its efficacy and safety profile, especially in hypertensive populations with co-morbidities like diabetes or chronic kidney disease [1].

Market Dynamics

Demand Drivers

The escalating prevalence of hypertension globally remains a fundamental driver for trandolapril's demand. According to the World Health Organization (WHO), over 1.28 billion adults aged 30–79 years globally suffer from hypertension, with projections indicating this number will continue to rise in tandem with aging populations and lifestyle factors [2].

Furthermore, the increased awareness of cardiovascular diseases (CVDs) and advances in diagnostic infrastructure bolster diagnosis rates, expanding the patient base for ACE inhibitors. The drug's positioning as a first-line therapy for hypertension and its use in heart failure management contribute significantly to sustained demand.

Regulatory and Patent Landscape

Trandolapril faced patent expirations in multiple markets over the last decade, leading to increased generic competition. Generic formulations typically undercut brand-name prices, impacting revenue streams for originator manufacturers [3]. Regulatory considerations, including safety warnings—such as those related to angioedema risk—affect prescribing behaviors and market penetration.

Competitive Landscape

The ACE inhibitor segment is heavily competitive, with several established agents like enalapril, lisinopril, ramipril, and captopril vying for market share. Trandolapril’s unique positioning as a drug with a specific pharmacokinetic profile (e.g., once-daily dosing) influences its appeal. However, the market’s commoditized nature and the significant availability of generics have constrained pricing power.

Additionally, the advent of alternative antihypertensive classes such as angiotensin receptor blockers (ARBs) and direct renin inhibitors offers competitors, with some patients switching due to ACE inhibitor-associated adverse effects like cough.

Pricing and Reimbursement Policies

Price sensitivity is prominent, especially in markets with centralized healthcare systems or substantial out-of-pocket expenses. Reimbursement policies impact access; where insurers favor generics, the market share for brand-name drugs like original trandolapril diminishes. Conversely, subsidies or formulary preferences can sustain demand.

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Financial Trajectory

Revenue Trends

Post patent expiry, revenue from the original formulations has reflected a decline consistent with generic entry. For example, Abbott’s Mavik experienced a marked decrease in sales following patent expiration, with generics capturing substantial market share [4].

Market Growth Opportunities

Despite generic competition, niche markets and specialized formulations (e.g., pediatric dosages, combination therapies) present growth avenues. Additionally, expanding into emerging economies with rising hypertension prevalence offers significant potential.

Research and Development Investments

Limited R&D activity specifically targeting trandolapril suggests the market is mature, with focus shifting toward combination regimens or new therapeutic targets. Nonetheless, incremental innovations—such as extended-release formulations—may extend product life cycles.

Strategic Partnerships and Alliances

Pharmaceutical companies pursue licensing, co-marketing, and distribution agreements, especially in markets where regulatory barriers or patent protections delay approval. Such collaborations can influence sales effectiveness and market penetration.

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Regulatory and Safety Considerations

Safety profiles and adverse effects influence long-term adoption. The risk of angioedema—a potentially severe allergic reaction—requires clinicians to monitor patients diligently. Regulatory agencies periodically update prescribing information, which can impact prescribing trends and, consequently, revenue.

Furthermore, evolving guidelines from organizations such as the American College of Cardiology (ACC) and the European Society of Cardiology (ESC) influence drug utilization patterns, favoring certain drug classes over others based on emerging evidence.

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Future Outlook

The global antihypertensive market is projected to grow at a CAGR of approximately 3–5% over the next five years, driven by demographic shifts and increasing awareness [5]. However, for drugs like trandolapril, future growth hinges on:

• Market penetration in emerging economies: Expanding healthcare infrastructure facilitates access.
• Formulation innovations: Extended-release or combination formulations improve adherence.
• Personalized medicine: Pharmacogenomics may influence patient selection, optimizing outcomes.
• Competitive innovations: Newer classes, such as ARBs or neprilysin inhibitors, could replace ACE inhibitors in certain indications.

Given decreasing brand revenues post-generic entry, manufacturers are likely to focus on niche markets or leverage strategic alliances to sustain revenue streams.

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Conclusion

Trandolapril's market dynamics are shaped by a confluence of clinical efficacy, competitive pressures, regulatory landscape, and healthcare economics. While the drug faces notable generic competition that constrains profitability, expanding global hypertensive burdens and niche therapy opportunities underpin its continued relevance. Evaluating these factors enables the anticipation of its financial trajectory and informs strategic decision-making in the pharmaceutical landscape.

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Key Takeaways

• Demand for trandolapril remains anchored in the high prevalence of hypertension worldwide, yet its revenue is significantly impacted by patent expirations and generic competition.
• Market share is influenced by evolving treatment guidelines, safety profiles, and competition from newer antihypertensive agents.
• Opportunities exist in emerging markets and through formulation innovations, but overall growth prospects are moderate.
• Regulatory updates and safety considerations continue to shape prescribing practices affected by adverse effect profiles.
• Strategic diversification, including combination therapies and niche indications, will be pivotal for sustaining long-term financial viability.

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FAQs

1. How has patent expiration affected trandolapril’s market share?
Patent expiration led to a surge in generic entries, dramatically reducing prices and original brand sales. As generics gained dominance, the market share of the patented formulations declined substantially, typical in the pharmaceutical lifecycle.

2. Are there any recent developments or formulations of trandolapril?
While most of the market consists of existing formulations, some companies explore combination therapies (e.g., with hydrochlorothiazide) and extended-release versions to improve patient adherence and clinical outcomes.

3. What are the primary competitors of trandolapril in the hypertension treatment market?
Other ACE inhibitors like enalapril, lisinopril, and ramipril, along with ARBs such as losartan and valsartan, serve as principal competitors, especially as some are favored due to lower side-effect profiles.

4. What is the prevalence of adverse effects associated with trandolapril?
Adverse effects include cough, hyperkalemia, hypotension, and angioedema. Serious reactions like angioedema, although rare, require prompt medical attention and influence prescribing decisions.

5. What is the outlook for trandolapril in the next decade?
While market growth may plateau due to generic competition, targeted use in specific patient populations and potential formulation or combination innovations could sustain relevance within the cardiovascular drug portfolio.

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References

[1] PubMed. "Pharmacology and Clinical Efficacy of Trandolapril." Accessed 2023.
[2] World Health Organization. "Global Status Report on Hypertension," 2021.
[3] FDA. "Patent Expiry and Generic Drug Entry," 2022.
[4] Abbott Laboratories Investor Reports, 2012–2022.
[5] MarketWatch. "Global Antihypertensive Market Forecast," 2023.