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-three 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:	127
Clinical Trials:	27
Patent Applications:	4,314
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
AstraZeneca	Phase 4
Heart Health Research Center	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
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-003	Aug 31, 1987
Merck	MEVACOR	lovastatin	TABLET;ORAL	019643-004	Dec 14, 1988

International Patents for MEVACOR

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P940098	PROCESS FOR THE PREPARATION OF HYPOCHOLESTEREMIC FERMENTATION PRODUCTS
Bosnia and Herzegovina	98222
Norway	155699
Germany	3062122
Canada	1161380	PRODUITS DE FERMENTATION HYPOCHOLESTEROLEMIQUES ET PROCEDE DE PREPARATION (HYPOCHOLESTEREMIC FERMENTATION PRODUCTS AND PROCESS OF PREPARATION)

MEVACOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of MEVACOR

Introduction

MEVACOR, introduced by Merck & Co., Inc. in 1987, was a groundbreaking cholesterol-reducing drug that belonged to the class of statins. This article delves into the market dynamics and financial trajectory of MEVACOR, highlighting its rise to dominance, the impact of competition, and the strategic maneuvers that shaped its market presence.

Discovery and Development

The journey of MEVACOR began decades before its market launch. The research behind statins, the class of drugs to which MEVACOR belongs, started with the understanding of cholesterol production in the body. This lengthy process involved numerous rejected compounds and significant investment in research and development (R&D). By the time MEVACOR was ready for market, Merck had already spent years and substantial resources on its development[1].

Market Launch and Initial Success

MEVACOR was launched in 1987 and quickly captured 42% of the market for cholesterol-reducing drugs within 18 months. Its success was fueled by its effectiveness in reducing cholesterol levels by 30% with minimal side effects and through innovative direct-to-consumer advertising. In its first year, MEVACOR earned an estimated $260 million, the highest sales ever for any prescription medicine at that time[1].

Market Dominance and Competition

MEVACOR's success led to a dominance in the anti-cholesterol market, but it also spurred competition. Other pharmaceutical companies developed similar but not identical compounds to compete with MEVACOR. Despite this, MEVACOR remained a market leader, supported by Merck's follow-on product, Zocor. However, competition from brand-name drugs like Pfizer's Lipitor eventually eroded MEVACOR's market share. By 2001, MEVACOR controlled less than 1% of the statin market, having been superseded by more innovative products[1].

Patent Expiration and Generic Competition

The patent for MEVACOR expired on December 17, 2001, marking a significant turning point. Generic versions of lovastatin, the active ingredient in MEVACOR, were immediately introduced by seven separate manufacturers at a significantly lower price. This led to a sharp decline in MEVACOR's sales, as generic lovastatin was priced at around $1 per pill, half the cost of MEVACOR[1].

Pricing Strategies

Despite the generic competition, Merck did not significantly lower the price of MEVACOR. Instead, the company capitalized on patient loyalty to the brand. This strategy is common in the pharmaceutical industry, where companies often maintain high prices for branded drugs even after generic alternatives become available. In a rare instance, Merck offered a brief discount on MEVACOR and Zocor in 1993 but quickly returned to normal pricing[1].

Over-the-Counter (OTC) Transition

In 2007, GlaxoSmithKline (GSK) obtained exclusive U.S. OTC marketing rights for MEVACOR from Merck. This move aimed to expand the drug's reach by making it available without a prescription for certain patient groups. The OTC version of MEVACOR was proposed for use in individuals with moderately elevated cholesterol and one or more heart disease risk factors. This transition marked a new phase in MEVACOR's market life, focusing on consumer health management[4].

Financial Impact

The financial trajectory of MEVACOR was marked by significant revenue generation during its patent-protected period. MEVACOR and its successor, Zocor, contributed substantially to Merck's revenue, with cholesterol-reducing drugs becoming the nation's pharmaceutical sales leaders, generating over $11 billion in sales per year in the U.S. alone. However, the expiration of MEVACOR's patent and the introduction of generic competition led to a decline in its financial contribution to Merck's bottom line[1].

Strategic Maneuvers

Merck's strategy to maintain market presence included leveraging its brand loyalty and the success of its follow-on products. The company also engaged in partnerships, such as the one with GSK for OTC marketing rights, to extend the drug's market life. Additionally, pharmaceutical companies often resort to mergers and acquisitions to manage declining revenues and absorb the financial impact of patent expirations and increased competition[2].

Industry Context

The pharmaceutical industry is characterized by high R&D costs and long development timelines. Each new drug can cost up to half a billion dollars to develop, including the costs of failed compounds. This high investment makes patent protection crucial for recouping costs and generating profits. The industry's response to declining revenues often involves cost-cutting measures and strategic mergers to achieve synergies and reduce expenses[1][2].

Market Evolution

The market for cholesterol-reducing drugs has evolved significantly since MEVACOR's introduction. There is now a greater focus on differentiating value and solutions that offer a higher certainty of benefit. This includes an increased interest in orphan drugs and treatments that target specific sub-populations of patients. The commercial success of drugs is now defined by their unique value proposition and the ability to demonstrate measurable benefits[3].

Key Takeaways

• Innovative Launch: MEVACOR was a pioneering drug in the statin class, capturing a significant market share quickly.
• Competition and Patent Expiration: Despite initial dominance, MEVACOR faced intense competition from brand-name and generic drugs after its patent expired.
• Pricing Strategies: Merck maintained high prices for MEVACOR, leveraging patient loyalty.
• OTC Transition: The drug transitioned to OTC status to extend its market life.
• Financial Impact: MEVACOR generated substantial revenue but declined post-patent expiration.
• Strategic Maneuvers: Partnerships and brand loyalty were key strategies to maintain market presence.

FAQs

What was the initial market impact of MEVACOR?

MEVACOR captured 42% of the market for cholesterol-reducing drugs within 18 months of its launch and earned an estimated $260 million in its first year, the highest sales ever for any prescription medicine at that time.

How did the expiration of MEVACOR's patent affect its market share?

The patent expiration led to the immediate introduction of generic versions of lovastatin, significantly reducing MEVACOR's market share and sales.

Why did Merck not lower the price of MEVACOR in response to generic competition?

Merck capitalized on patient loyalty to the brand, a common strategy in the pharmaceutical industry where companies maintain high prices for branded drugs despite generic alternatives.

What was the significance of MEVACOR's transition to OTC status?

The transition allowed MEVACOR to be marketed without a prescription for certain patient groups, extending its market life and focusing on consumer health management.

How does the pharmaceutical industry typically respond to declining revenues due to patent expirations?

The industry often resorts to cost-cutting measures, mergers, and acquisitions to achieve synergies and reduce expenses, as well as leveraging brand loyalty and follow-on products.

Sources

1. Boston Fed: "Too Much of a Good Thing Can Be Bad" - Regional Review, 2003.
2. Mizuho Group: "Mizuho Industry Focus" - Pharmaceutical Industry Mergers, 2014.
3. Pharm Exec: "The End of Pharma Marketing— or a New Beginning?" - 2015.
4. BioSpace: "GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR from Merck & Co., Inc." - 2007.