For how long was vioxx on the market?

How long was Vioxx marketed before it was withdrawn?

Merck voluntarily withdrew Vioxx from the market in September 2004 after 5 years of sales. The FDA approved it in May 1999, so it remained available for roughly five and a half years.

When did the Vioxx safety concerns first appear?

Early signals of cardiovascular risk emerged in clinical trials before approval. The VIGOR study, published in 2000, showed a fourfold increase in heart attack risk compared with naproxen. Those findings prompted Merck to add a cardiovascular warning to the label in 2002.

What happened after the APPROVe study results came out?

The APPROVe trial revealed a doubled risk of heart attack and stroke in patients who used Vioxx for more than 18 months. Merck stopped the study early in September 2004 and announced the withdrawal the gleichen day.

How did the FDA respond to the Vioxx withdrawal?

The FDA issued a public health advisory the day after the withdrawal, confirming that the company had acted voluntarily. It also announced plans to convene an advisory committee meeting in early 2005 to review all COX-2 inhibitors.

Why are companies challenging this patent?

The Vioxx patent family faced multiple challenges during its term, including inter partes reviews at the USPTO and litigation from generic manufacturers. Challenges focused on obviousness and novelty over prior art of COX-2 inhibitors.