MEVACOR Drug Patent Profile

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

Mevacor is a drug marketed by Merck and is included in one NDA.

The generic ingredient in MEVACOR is lovastatin. There are thirty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the lovastatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mevacor

A generic version of MEVACOR was approved as lovastatin by ACTAVIS ELIZABETH on December 17^th, 2001.

Summary for MEVACOR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	27
Drug Prices:	Drug price information for MEVACOR
DailyMed Link:	MEVACOR at DailyMed

See drug prices for MEVACOR

See drug sales revenues for MEVACOR

Recent Clinical Trials for MEVACOR

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

Sponsor	Phase
Heart Health Research Center	Phase 4
AstraZeneca	Phase 4
Brigham and Women's Hospital	Phase 4

See all MEVACOR clinical trials

US Patents and Regulatory Information for MEVACOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-002	Mar 28, 1991		DISCN	Yes	No
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-003	Aug 31, 1987		DISCN	Yes	No
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-004	Dec 14, 1988		DISCN	Yes	No

Expired US Patents for MEVACOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-002	Mar 28, 1991	4,231,938*PED
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-004	Dec 14, 1988	4,231,938*PED
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-003	Aug 31, 1987	4,231,938*PED

International Patents for MEVACOR

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

Country	Patent Number	Title	Estimated Expiration
Denmark	254180
European Patent Office	0022478	POLYHYDRO-3,7-DIMETHYL-8-(2-(TETRAHYDRO-4-HYDROXY-6-OXO-2H-PYRAN-2-YL)-ETHYL)-1-NAPHTHYLENYL-2-METHYLBUTANOATES, CORRESPONDING HYDROXY ACIDS, PROCESS FOR PREPARING AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME
Hungary	182144	PROCESS FOR PREPARING COMPOUNDS WITH HYPOCHOLESTEREMIC ACTIVITY BY MEANS OF FERMENTATION
Denmark	149003
U.S.S.R.	1253432	Способ получения оксикислот или их лактонов (METHOD OF PRODUCING OXYACIDS OR LACTONES THEREOF)
Ireland	801232
Philippines	16913	HYPOCHOLESTEREMIC FERMENTATION PRODUCTS AND PROCESS OF PREPARATION

Market Dynamics and Financial Trajectory for MEVACOR (Lovastatin)

Last updated: July 29, 2025

Introduction

MEVACOR, the brand name for lovastatin, represents a cornerstone in the management of hypercholesterolemia and cardiovascular risk reduction. Introduced in the late 1980s, MEVACOR was among the first statins to receive FDA approval, profoundly impacting the global cholesterol-lowering medication market. This article explores the evolving market dynamics and financial trajectory of MEVACOR within the context of the broader pharmaceutical landscape.

Historical Context and Market Entry

Launched by Merck & Co. in 1987, MEVACOR marked a pivotal advancement in lipid management therapies. Its mechanism of inhibiting HMG-CoA reductase established a new paradigm in cardiovascular disease prevention. Initially, MEVACOR experienced rapid uptake, driven by compelling clinical evidence demonstrating its efficacy in reducing LDL cholesterol levels and cardiovascular events [1].

Market Evolution and Competitive Landscape

Early Market Dominance

During the early 1990s, MEVACOR enjoyed substantial market share, supported by its proven safety profile and efficacy. The drug's patent life, extending into the late 1990s (patents expired around 1998), enabled Merck to maximize revenues, particularly amid minimal competition from other statins.

Introduction of Patent Expirations and Generic Competition

The expiration of key patents in the early 2000s precipitated widespread generic entry. Lovastatin's patent expiry led to a significant decline in brand-name sales; generic formulations rapidly captured market share, often sold at a fraction of the branded price [2].

Diversification of the Statin Class

Post-patent, the market saw proliferation of new, more potent, and better-tolerated statins such as atorvastatin and rosuvastatin. These agents offered improved dosing convenience and additional efficacy, overshadowing MEVACOR in both prescriber preference and market share.

Market Dynamics in the Contemporary Context

Shift Toward Combination Therapies

Current trends favorator combination therapies, integrating statins with drugs like ezetimibe or PCSK9 inhibitors, aiming for more aggressive LDL lowering in high-risk populations. MEVACOR’s role has been diminished in this landscape due to limited options for combination formulations and lower potency.

Regulatory and Prescriber Trends

Regulatory updates emphasizing guideline-directed therapy have influenced prescriber patterns. The American College of Cardiology/American Heart Association (ACC/AHA) guidelines currently prioritize newer statins with superior pharmacokinetic profiles and dosing flexibility, marginalizing lovastatin in primary care [3].

Market Size and Revenue Trends

Pre-patent expiry, MEVACOR generated peak annual revenues exceeding $1 billion globally. Post-expiry, sales dwindled considerably, with estimates indicating a decline of over 80% in developed markets by the late 2010s. Although still available, MEVACOR’s contribution to Merck’s revenue has become minimal, overshadowed by newer branded statins and novel lipid-lowering therapies.

Financial Trajectory and Future Outlook

Current Revenue and Market Position

Today, MEVACOR remains a generic medication with limited marketing efforts. Its revenue trajectories are primarily driven by existing prescriptions rather than new sales. In markets like the US, annual sales are estimated to be below $50 million—a stark contrast to peak pre-patent expiry figures [4].

Patent and Regulatory Factors

Being off-patent, MEVACOR faces negligible exclusivity barriers, with its pricing heavily influenced by competitive generic markets. Regulatory factors, including patent expiries and bioequivalence standards, facilitate widespread generic access, further constraining financial prospects.

Potential for Niche or Reformulation Strategies

While the mainline market has largely abandoned lovastatin, potential niche applications, such as use in specific hyperlipidemia subtypes or combination formulations, could offer incremental revenue streams. However, these are unlikely to offset the declining trend in traditional monotherapy sales.

Implications for Stakeholders

Pharmaceutical Manufacturers

Manufacturers aiming to sustain revenues from MEVACOR must explore lifecycle management strategies, including reformulations, biosimilar development, or positioning in specialty markets. Merck and others have deprecated focus on lovastatin, redirecting investments toward innovative lipid-lowering agents.

Investors

Investors should recognize MEVACOR’s current commoditized status, with minimal growth potential. Portfolio diversification into newer therapies aligns better with future market prospects in cardiovascular drugs.

Healthcare Providers

Clinicians predominantly prescribe higher potency statins or combination therapies, often relegating MEVACOR to historical relevance. Its use remains confined to specific cases where cost considerations dominate or when newer agents are contraindicated.

Conclusion

The market dynamics and financial trajectory of MEVACOR encapsulate the lifecycle typical of first-generation pharmaceuticals. From pioneering lipid-lowering therapy to obsolescence in the face of innovation and patent expiration, MEVACOR’s market presence has diminished substantially. While still available as a generic, its role in contemporary clinical practice and revenue generation remains minimal. Success in the modern pharmacotherapeutic landscape demands continual innovation, lifecycle management, and adaptation to evolving clinical guidelines.

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Key Takeaways

• Market evolution for MEVACOR reflects the broader pharmaceutical trend of rapid growth, patent expiration, and subsequent decline in market share post-generic entry.
• Competitive advancements in statin potency and tolerability have rendered MEVACOR less favorable compared to newer agents like atorvastatin and rosuvastatin.
• Financial prospects of MEVACOR are limited, with current revenues mainly driven by existing prescriptions rather than growth.
• Strategic positioning for manufacturers involves lifecycle management, such as reformulations or exploring niche markets, though the overall outlook remains subdued.
• Regulatory and clinical trends favor newer therapies, further constraining MEVACOR’s commercial relevance.

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FAQs

1. What led to the decline of MEVACOR’s market share?
   The expiration of patent protection facilitated generic competition, and the introduction of more potent, better-tolerated statins shifted prescriber preferences, gradually diminishing MEVACOR’s market dominance.

2. Can MEVACOR be used in current clinical practice?
   Yes. It remains an option for certain patients, especially where cost constraints limit access to newer agents, although its use is now largely historical.

3. What is the current revenue outlook for MEVACOR?
   Revenue is minimal—estimated at below $50 million annually—driven mainly by existing prescriptions rather than new sales.

4. Are there ongoing efforts to develop reformulations or new indications for lovastatin?
   Limited. Most lifecycle strategies focus on newer drugs; however, incremental gains via niche indications or combination therapy developments are possible but unlikely to reverse its declining trend.

5. How does the competition from PCSK9 inhibitors impact the market for statins like MEVACOR?
   PCSK9 inhibitors offer significant LDL cholesterol reduction for high-risk populations but are costly, limiting their use to specific patient groups. Nevertheless, their advent has further marginalized older, less potent drugs like MEVACOR in the broader statin market.

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References

[1] National Institutes of Health, "Statins and Cardiovascular Disease Prevention," 2021.
[2] U.S. Food and Drug Administration, "Patent and Generic Drug Data," 2022.
[3] American College of Cardiology/American Heart Association, "2018 Guidelines on Management of Blood Cholesterol," 2018.
[4] IQVIA, "Pharmaceutical Market Data," 2022.