MAVIK Drug Patent Profile

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

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

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

International Patents for MAVIK

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

Country	Patent Number	Title	Estimated Expiration
South Korea	840002810
Bulgaria	60936
Israel	84058

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

Last updated: February 3, 2026

What is the current investment landscape for MAVIK?

MAVIK (trandolapril), an angiotensin-converting enzyme (ACE) inhibitor, is marketed primarily for hypertension and heart failure. It remains a branded drug with limited generic competition due to patent protections and market dynamics. Its global annual sales, approximately $100 million, have shown stability over recent years, driven by established positioning and a broad patient base. The drug’s sales are concentrated in North America and Europe, accounting for roughly 70% of revenue.

Major pharmaceutical players, including Takeda (original developer), hold marketing rights. Despite generic entry in some regions, branded MAVIK maintains a presence through brand loyalty and prescriber preference. The competitive landscape faces pressure from newer antihypertensive agents and fixed-dose combinations, potentially impacting future growth.

What are the core clinical and regulatory fundamentals of MAVIK?

Clinical Profile:

• Indications: Hypertension, heart failure
• Dosage forms: Oral tablets
• Key data: Demonstrated efficacy in reducing blood pressure and improving cardiac outcomes in multiple Phase III trials
• Safety profile: Mild side effects include cough, hyperkalemia, and angioedema; similar to other ACE inhibitors

Regulatory Status:

• Approvals: US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other major regulators
• Patent status: Patents expired or nearing expiration in various jurisdictions, opening pathways for generics
• Labeling: Established labeling with minimal recent updates, maintaining market stability

What are the main market drivers and risks?

Market Drivers:

• Prevalence: Hypertension affects over 1.3 billion people globally; heart failure prevalence exceeds 60 million
• Treatment patterns: Long-term antihypertensive therapy remains standard, favoring drug adherence
• Prescriber preference: Continued trust in established ACE inhibitors with proven safety and efficacy profiles

Market Risks:

• Competition: Generic versions and new drug classes (e.g., angiotensin receptor blockers, SGLT2 inhibitors) threaten market share
• Patent cliffs: Patent expirations in key markets from 2023 onward could erode pricing power
• Regulatory pressures: Changes in prescribing guidelines, or increased safety monitoring, can affect sales
• Patent litigation: Possibility of patent challenges or patent extensions for follow-on formulations

What are the investment fundamentals of MAVIK?

Aspect	Details
Market size	Approximately $100 million annually (global)
Growth outlook	Flat to modest decline due to generics and competition
Patent situation	Patents expired or expiring in 2023-2025
Revenue stability	Moderate; depends on prescriber inertia and market loyalty
R&D pipeline	No new formulations or indications currently underway
Competitive threats	Generics, novel hypertensive agents, fixed-dose combos

What are the financial implications for investors?

The company's earnings from MAVIK are likely to decline as patent protection wanes. Without new indications or formulations, revenue decline could accelerate. Market adaptation depends on the company's ability to offset losses through pipeline diversification or expansion into emerging markets.

What strategic moves could impact MAVIK’s future?

• Patent extension filings in select markets
• Development of combination therapies involving MAVIK components
• Expansion into emerging markets with higher hypertension prevalence
• Investment in new hypertension or heart failure therapies

Key takeaways

MAVIK presents a low-growth, mature pharmaceutical profile. Market saturation, patent expirations, and stiff competition from generics and newer drugs diminish its revenue prospects. Its core holds stable in established markets, but long-term growth requires pipeline innovation or strategic repositioning.

FAQs

1. Will MAVIK regain market share amid generic competition?
Unlikely without new formulations or indications; prescriber loyalty and brand reputation offer limited protection as generics dominate the market.

2. Are there pipeline opportunities for MAVIK?
No significant pipeline developments are announced; the focus appears on maintaining existing indications and markets.

3. How does the expiry of patents affect investment in MAVIK?
Patent expirations from 2023 to 2025 are expected to reduce sales revenue as generic alternatives enter the market, decreasing pricing power.

4. What markets present growth opportunities for MAVIK?
Emerging markets with rising hypertension prevalence could offer incremental growth, contingent on regulatory approvals and pricing strategies.

5. How do newer antihypertensives impact MAVIK’s future?
Agents like SGLT2 inhibitors and combination drugs are increasingly favored, potentially overshadowing traditional ACE inhibitors like MAVIK.

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Sources

1. IQVIA, "Global Sales Data," 2022.
2. FDA and EMA approvals and patent filings.
3. Company financial disclosures.
4. Market research reports (e.g., EvaluatePharma).
5. Clinical trial summaries (PubMed, ClinicalTrials.gov).