Plavix falls over US patent cliff

Bristol-Myers Squibb’s anti-platelet therapy Plavix (clopidogrel) has become the latest blockbuster to lose patent protection in the US.

A mainstay of heart disease treatment since 1997, Plavix faces immediate generic competition from Cardinal Health.

BMS, who markets Plavix in partnership with Sanofi, has said it will cease promoting the drug immediately following patent expiry.

Used together with aspirin, Plavix is the standard blood-thinning therapy for people who have suffered a heart attack.

The product earned BMS $7.1bn in 2011, a third of the company’s revenue.

BMS has decided not to follow the example of Pfizer, who promoted Lipitor extensively for six months after its US patent expiry, because the usual six-month exclusivity to one generic supplier will not apply.

The reason is that the first authorised supplier of generic clopidogrel, Apotex, forfeited its exclusivity period due to unlicensed sales in 2006.

As a result, seven companies have already received tentative approval to sell generic clopidogrel in the US. Cardinal Health plans a next-day launch. A spokesman for Sun Pharmaceutical Industries said the company would lose no time: “I would not be surprised if there was a stopwatch involved.”

BMS’s 2011 annual report predicted “a rapid, precipitous and material decline in Plavix net sales” following expiry of its US patent.

The company has developed a new blood-thinning drug, Eliquis, in partnership with Pfizer. Its FDA approval for stroke prevention is expected in June.