Apotex debuts first generic Plavix in USA on an "at risk" basis

Just days after the US District Court for the Southern District of New York rejected a proposed agreement between France's Sanofi-Aventis, its US licensee Bristol-Myers Squibb and Canadian generic drugmaker Apotek relating to the blockbuster blood-thinning agent Plavix (clopidogrel bisulfate; Marketletter August 7), the latter company announced the launch of a generic version of the drug, in a 75mg formulation, in the USA on August 8.

The deal, which would have delayed a generic competitor for Plavix to 2011 - which is several months before the time that Sanofi-Aventis and B-MS claim that the relevant composition of matter patent (US patent number 4,847,265) expires, has also become the subject of a US Department of Justice criminal investigation, with both pharmaceutical majors having received grand jury sub poenas in connection with this.

Under the terms of the agreement, the majors said that they would pay Apotex a minimum of $40.0 million to end a patent challenge by the Canadian firm. And, according to a report in the UK's Financial Times, had undertaken not to introduce their own generic versions of Plavix to compete with that of Apotex. These so-called "authorized generics" are coming under increasing criticism and scrutiny in the USA (Marketletters passim).