MAVIK Drug Patent Profile

Which patents cover Mavik, and what generic alternatives are available?

Mavik is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in MAVIK is trandolapril. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the trandolapril profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mavik

A generic version of MAVIK was approved as trandolapril by AUROBINDO PHARMA on June 12^th, 2007.

Summary for MAVIK

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	68
Patent Applications:	5,638
What excipients (inactive ingredients) are in MAVIK?	MAVIK excipients list
DailyMed Link:	MAVIK at DailyMed

Paragraph IV (Patent) Challenges for MAVIK

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 MAVIK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-001	Apr 26, 1996		DISCN	Yes	No
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-002	Apr 26, 1996		DISCN	Yes	No
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-003	Apr 26, 1996		DISCN	Yes	No

Expired US Patents for MAVIK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-002	Apr 26, 1996
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-003	Apr 26, 1996
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-001	Apr 26, 1996
Abbvie	MAVIK	trandolapril	TABLET;ORAL	020528-003	Apr 26, 1996

International Patents for MAVIK

See the table below for patents covering MAVIK around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	55867	NEW DERIVATIVES OF BICYCLIC AMINOACIDS,PROCESSES FOR THEIR PREPARATION,AGENTS CONTAINING THESE COMPOUNDS AND THEIR USE,AND NEW BICYCLIC AMINOACIDS AS INTERMEDIATES AND PROCESSES FOR THEIR PREPARATION
Finland	883456
Denmark	171232
Algeria	490	Nouveaux dérivés d'acides aminés bicycliques, procédé pour leur préparation, médicaments contenant ces composés et leur utilisation, nouveaux acides aminés bicycliques comme produits intermédiaires etprocédé pour leur préparation.

Supplementary Protection Certificates for MAVIK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0084164	SPC/GB93/146	United Kingdom		SPC/GB93/146:, EXPIRES: 20070218

Market Dynamics and Financial Trajectory for MAVIK (Sulfenamide-based Vasodilator)

Last updated: July 29, 2025

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Introduction

MAVIK (trandolapril), marketed by Takeda Pharmaceuticals, is an angiotensin-converting enzyme (ACE) inhibitor primarily prescribed for hypertension and heart failure management. Originally approved in 1995, it has established itself within a competitive cardiovascular drug landscape. This report analyzes MAVIK’s current market dynamics, financial trajectory, and strategic outlook amid evolving healthcare demands and competitive pressures.

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Market Overview

The global antihypertensive drugs market is a well-established, multi-billion-dollar sector projected to grow steadily at a Compound Annual Growth Rate (CAGR) of approximately 3-5% through 2027 [1]. MAVIK occupies a niche within this broader landscape, targeting hypertensive patients with comorbid conditions such as heart failure, where ACE inhibitors show proven efficacy.

Key competitive positioning factors include:

• Generic Competition: Post-patent expiry, MAVIK's active ingredient, trandolapril, faces generic competition, exerting pressure on pricing and margins.
• Clinical Acceptance: As a first-line therapy in hypertension and heart failure, it benefits from strong clinical support, but newer drug classes and combination therapies are gaining prominence.
• Regulatory Environment: Stringent regulatory standards influence marketing and formulation strategies, impacting future revenue streams.

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Market Dynamics

1. Patent and Generic Competition
MAVIK's initial patent protection expired in the early 2010s, leading to the entry of generic versions. This shift significantly diluted market share and reduced revenues, aligning with typical lifecycle trajectories of branded pharmaceuticals [2].

2. Shifts in Treatment Paradigms
Recent trends favor combination therapies — for example, ACE inhibitors combined with calcium channel blockers or diuretics — which may diminish the standalone market for MAVIK [3]. Furthermore, the emergence of angiotensin receptor blockers (ARBs) offers alternatives that some guidelines favor, potentially overshadowing traditional ACE inhibitors.

3. Market Penetration and Geographic Factors
MAVIK is predominantly marketed in North America and Europe, where healthcare infrastructure supports widespread prescribing. In emerging markets, affordability and distribution barriers limit penetration but also present growth opportunities as healthcare access improves.

4. Patient Preference and Compliance
Once a cornerstone in cardiovascular therapy, ACE inhibitors like MAVIK are favored for their proven efficacy and safety profiles. However, side effects such as cough and angioedema, associated with ACE inhibitors, have propelled the adoption of alternative therapies.

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Financial Trajectory

Historical Revenue and Profit Trends
Following patent expiration, revenues for MAVIK declined sharply, consistent with typical brand erosion patterns [4]. As generic versions flood the market, profit margins diminish owing to intensified price competition.

Forecasted Revenue Streams
Current projections indicate marginal growth in specific niche markets, driven by:

• Expansion in developing countries where ACE inhibitors are still preferred.
• Potential renewed interest via combination drug formulations.
• Lifecycle management strategies, including new indications or formulation improvements.

Strategic Initiatives Influencing Future Outlook:

• Line Extensions and Fixed-Dose Combinations (FDCs): Development of combined therapies aims to bolster therapeutic adherence and market share.
• Regulatory Approvals for New Indications: Pursuing expansion into comorbid conditions, e.g., diabetic nephropathy, may open ancillary revenue options.
• Partnerships and Collaborations: Licensing deals with generics manufacturers enhance access and volume sales in emerging markets.

Impact of Pricing and Reimbursement Trends:
Health system pressures for cost containment in mature markets are leading to aggressive price negotiations and formularies favoring generic and biosimilar options. TAKEDA's strategy includes adopting competitive pricing models to sustain revenue in a declining branded segment.

Forecast Summary:

• Post-patent loss, MAVIK’s revenues were projected to decline by approximately 10–15% annually unless mitigated through strategic initiatives.
• Long-term stability likely depends on diversification into combination drugs and expanding geographic footprint.
• Margins are under pressure, necessitating cost optimization and lifecycle extension strategies.

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Emerging Opportunities and Challenges

Opportunities

• Hybrid Therapies: FDCs combining MAVIK with diuretics or other antihypertensives can improve patient adherence.
• New Formulations: Development of extended-release or parenteral forms to enhance compliance.
• Digital Health Integration: Leveraging digital tools for adherence monitoring may improve outcomes and preserve market relevance.

Challenges

• Market Saturation: Excess supply of generics limits pricing power.
• Competitive Innovation: New drug classes, such as ARBs and direct renin inhibitors, threaten to further reduce MAVIK’s share.
• Regulatory and Reimbursement Barriers: Changing policies can delay launches or increase compliance costs.

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Regulatory and Patent Landscape

While MAVIK’s patent protections have expired, Takeda may explore supplementary patent filings for formulations or new uses, extending commercial exclusivity. Regulatory pathways for biosimilars and generics continue to influence the competitive landscape, impacting revenue forecasts.

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Key Takeaways

• MAVIK’s revenue trajectory is under significant pressure due to patent expiry and generic competition, with declining sales historically evident.
• Strategic diversification into combination therapies and expansion into emerging markets could mitigate typical patent cliff impacts.
• Market dynamics favor highly efficacious, well-tolerated therapies; MAVIK must innovate or reposition to retain relevance.
• Pricing pressures in mature markets necessitate cost-efficient manufacturing and value-based pricing strategies.
• Future growth hinges on lifecycle management, including exploring new indications, formulations, and strategic partnerships.

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FAQs

1. What factors most significantly impacted MAVIK’s sales post-patent expiry?
The entry of generic competitors diluted market share, leading to reduced pricing power and diminished revenues.

2. How is MAVIK positioned against newer antihypertensive agents like ARBs?
While effective, MAVIK faces competition from ARBs, which are often preferred for their lower incidence of side effects such as cough, influencing prescriber choice.

3. What strategies can extend MAVIK’s market life?
Developing fixed-dose combinations, expanding into new indications, optimizing formulations, and increasing presence in emerging markets are key strategies.

4. Which markets offer the most growth potential for MAVIK?
Emerging markets, where generic penetration is still evolving, and regions with rising hypertensive disease burden, present promising avenues.

5. How do pricing and reimbursement policies influence MAVIK’s future?
Cost containment initiatives and strict reimbursement criteria favor generics, challenging branded drugs like MAVIK to adapt through value-based pricing and cost efficiencies.

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References

[1] Global Data. "Antihypertensive Drugs Market Analysis." 2022.
[2] U.S. Patent and Trademark Office. "Patent Protection for Trandolapril," 2000.
[3] American College of Cardiology. "Hypertension Treatment Guidelines," 2021.
[4] IQVIA. "Pharmaceutical Sales Trends," 2022.