Rise in US market entry delays for generics

The number of agreements between research-based drugmakers and potential generic competitors to delay the introduction of generic drugs into the US market after patent-expiry has recently grown, according to a report in the St Louis Post-Dispatch newspaper. The increase is partly explained by the ruling in the 11th Circuit US Court of Appeals (Marketletter March 14, 2005), which found that the Federal Trade Commission had exceeded its powers in blocking an agreement between US drugmakers Schering-Plough and Upsher-Smith Laboratories over K-DUR, a controlled-release potassium chloride supplement. Late last year, the US Supreme Court dismissed the FTC's appeal of the verdict without comment.

Andrew Barlow, a founding partner of the Washington DC-based anti-trust specialist law firm Doyle, Barlow & Mazard, told the Post-Dispatch: "these agreements are becoming more common and I think their numbers will increase in the future. The [drug] companies and their lawyers have become more comfortable." The FTC is due to issue a final report on its analysis of such deals early next year (Marketletter April 3).