VIOXX Drug Patent Profile

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

Vioxx is a drug marketed by Merck and is included in two NDAs.

The generic ingredient in VIOXX is rofecoxib. There are two drug master file entries for this compound. Additional details are available on the rofecoxib profile page.

Summary for VIOXX

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	115
Patent Applications:	2,724
DailyMed Link:	VIOXX at DailyMed

US Patents and Regulatory Information for VIOXX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-001	May 20, 1999		DISCN	No	No
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-002	May 20, 1999		DISCN	No	No
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-002	May 20, 1999		DISCN	No	No
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-001	May 20, 1999		DISCN	No	No
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-003	Feb 25, 2000		DISCN	No	No

Expired US Patents for VIOXX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-001	May 20, 1999	5,691,374*PED
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-003	Feb 25, 2000	5,474,995*PED
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-002	May 20, 1999	5,691,374*PED
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-002	May 20, 1999	5,474,995*PED
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-001	May 20, 1999	5,474,995*PED
Merck	VIOXX	rofecoxib	SUSPENSION;ORAL	021052-001	May 20, 1999	5,474,995*PED
Merck	VIOXX	rofecoxib	TABLET;ORAL	021042-003	Feb 25, 2000	6,063,811*PED

International Patents for VIOXX

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9518799
South Korea	20000011082
Bulgaria	63082
European Patent Office	0828724	DIARYL-5-OXYGENE-2-(5H)-FURANONES UTILES COMME INHIBITEURS DE COX-2 (DIARYL-5-OXYGENATED-2-(5H)-FURANONES AS COX-2 INHIBITORS)
Latvia	12209	AR FENILGRUPU AIZVIETOTI HETEROCIKLI KĀ CIKLOOKSIGENĀZES-2 INHIBITORI (PHENYL HETEROCYCLES AS CYCLOOXYGENASE-2 INHIBITORS)
Japan	2977137
United Kingdom	9422158

VIOXX Market Analysis and Financial Projection Experimental

The Rise and Fall of Vioxx: Understanding the Market Dynamics and Financial Trajectory

Introduction

Vioxx, a non-steroidal anti-inflammatory drug (NSAID) developed by Merck (known as MSD in some regions), was once a blockbuster drug that dominated the market for pain management, particularly for patients with osteoarthritis. However, its success was short-lived due to severe safety concerns. Here, we delve into the market dynamics and financial trajectory of Vioxx, from its approval to its eventual withdrawal.

Approval and Initial Success

FDA Approval and Market Entry

Vioxx was approved by the FDA in May 1999, marking a significant milestone for Merck. The drug was touted as a safer alternative to traditional NSAIDs due to its reduced risk of gastrointestinal side effects[1][3][4].

Marketing and Promotion

Merck invested heavily in promoting Vioxx. The company conducted the VIGOR trial, which showed that Vioxx halved the risk of stomach damage compared to naproxen. This data was widely publicized, with Merck purchasing nearly 1 million reprints of the study to distribute to doctors and spending $160 million on direct-to-consumer advertising in the US[2].

Early Financial Performance

By the end of 2000, Vioxx had generated significant revenue, bringing in about $2 billion in the US alone. This success continued, with Vioxx earning over $2 billion annually, making it a blockbuster drug[2][3].

Market Dominance and Expansion

Blockbuster Status

Vioxx quickly became one of Merck's top-selling drugs, representing 11% of the company's global sales in 2003, with revenues of $2.5 billion that year. It was prescribed to over 20 million Americans and was a major contributor to Merck's financial health[1][3][5].

Competitive Landscape

The pharmaceutical industry is highly lucrative, with high margins and intense competition. Vioxx's success was part of Merck's strategy to offset the loss of revenue from patent expirations of other key drugs like Mevacor, Pepcid, and Prilosec. Merck faced significant competition from other pharmaceutical companies, including Pfizer, which was developing a similar COX-2 inhibitor, Celebrex[2][5].

Safety Concerns and Regulatory Scrutiny

Early Warning Signs

Despite its initial success, Vioxx's safety profile began to raise concerns. The VIGOR trial, while showing reduced gastrointestinal side effects, also revealed a higher incidence of heart attacks among Vioxx users compared to those taking naproxen. This data should have flagged potential cardiovascular risks, but Merck continued to aggressively market the drug[2][4].

Clinical Trials and Adverse Events

Further clinical trials, such as Protocol 906, reinforced these concerns, showing that Vioxx caused more cardiovascular side effects than its competitors. However, Merck's internal communications suggest that the company was keen to keep these findings under wraps to avoid damaging the drug's reputation[2].

Regulatory Action

In September 2004, an outside panel overseeing the APPROVe study recommended halting the trial due to increased cardiovascular risks associated with Vioxx. This led Merck to voluntarily withdraw Vioxx from the global market on September 30, 2004[3][4].

Financial Impact of Withdrawal

Immediate Financial Consequences

The withdrawal of Vioxx had a devastating impact on Merck's finances. The company's shares plummeted by 27%, erasing $26.8 billion from its market capitalization. Vioxx's loss was expected to shave around 20% off Merck's profit for that year[3].

Long-Term Financial Implications

The financial fallout extended beyond the immediate withdrawal. Merck faced significant litigation costs, with estimates suggesting that the company paid nearly $6 billion in settlements, including a $950 million settlement with the US government in 2011[4].

Impact on Merck's Portfolio

Vioxx's demise also highlighted Merck's reliance on blockbuster drugs and the risks associated with their failure. The company's inability to replace Vioxx with new successful drugs led to further financial struggles, particularly as other key drugs like Zocor lost patent protection[3].

Market Dynamics Post-Withdrawal

Shift in Prescribing Practices

The withdrawal of Vioxx led to a significant shift in prescribing practices. Prescriptions for Vioxx and other COX-2 inhibitors, such as Celebrex, declined sharply. In England, for example, Vioxx prescriptions dropped from over 2.1 million in 2003 to virtually none after its withdrawal, while Celebrex prescriptions also saw a substantial decline[4].

Regulatory Changes

The Vioxx saga prompted a re-evaluation of the entire class of NSAIDs and led to changes in regulatory practices. The European Medicines Agency (EMA) reviewed the safety of all COX-2 inhibitors and implemented new contraindications and warnings. This incident also strengthened pharmacovigilance systems globally[4].

Key Takeaways

• Rapid Rise and Fall: Vioxx's market success was swift, but its withdrawal due to safety concerns was equally rapid.
• Financial Impact: The drug's withdrawal led to significant financial losses for Merck, including a major hit to its market capitalization and substantial litigation costs.
• Regulatory Changes: The Vioxx case led to enhanced regulatory scrutiny and changes in pharmacovigilance practices.
• Market Shifts: The incident resulted in a shift in prescribing practices, affecting not just Vioxx but the entire class of COX-2 inhibitors.

FAQs

What was the primary reason for Vioxx's withdrawal from the market?

Vioxx was withdrawn due to increased cardiovascular risks, including heart attacks and strokes, as revealed by several clinical trials.

How much revenue did Vioxx generate annually at its peak?

At its peak, Vioxx generated over $2.5 billion in annual sales.

What was the impact of Vioxx's withdrawal on Merck's stock price?

Merck's stock price dropped by 27%, erasing $26.8 billion from its market capitalization.

How did the Vioxx incident affect regulatory practices?

The Vioxx incident led to a strengthening of pharmacovigilance systems and a re-evaluation of the safety of NSAIDs, particularly COX-2 inhibitors.

What were some of the long-term financial implications for Merck following Vioxx's withdrawal?

Merck faced significant litigation costs, estimated to be nearly $6 billion, and struggled to replace Vioxx with new successful drugs, leading to further financial challenges.

Sources

1. A Case Study of Vioxx using STAMP - Nancy Leveson
2. How Merck made a killing - Prospect Magazine
3. Merck Pulls Vioxx From Market After Link To Heart Problems - Wharton School of the University of Pennsylvania
4. Still feeling the Vioxx pain - The Pharmaceutical Journal
5. THE VIOXX STORY - Beasley Allen Law Firm