News March 2007

Pfizer Launches Its Own Generic Drug

Mylan Laboratories Inc. said Friday it launched generic versions of Pfizer Inc.'s blockbuster Norvasc blood-pressure drug, a day after a federal court ruled a Pfizer patent was invalid.

In response, Pfizer said its plans to launch its own generic version of the drug, which had sales of about $2.7 billion last year and is Pfizer's second-biggest selling product.

Mylan said it has triggered a 180-day period for which it will have exclusive rights to sell its generic forms of Norvasc. Mylan said it launched three dosage forms of the drug.

Pfizer said it will continue to pursue all available legal remedies to protect the market for Norvasc through a six-month pediatric exclusivity period that expires in September 2007.

Norvasc will also remain on the market, the company said.

The Court of Appeals for the Federal Circuit Thursday reversed a lower court patent decision that favored Pfizer in its bid to prevent Canadian drugmaker Apotex Inc. from launching a generic form of Norvasc.

Apotex said Thursday that no company would have exclusivity over Norvasc generics - putting it in conflict with Mylan's position on Friday. The Canadian company said Thursday it expects to launch the product "in the very near future."

Apotex did not immediately return calls for comment on Friday.

Generic drugmakers can gain a cash infusion from such exclusivity periods, which federal lawmakers created as an incentive for companies to challenge weak patents.

Mylan in October 2005 won final approval for its generic Norvasc, but held off launching its product as it continued to wage its own patent battle with Pfizer.

Merrill Lynch analyst Gregg Gilbert said in a research note on Thursday that, while Mylan had final approval, Apotex was among several generic drugmakers that have only tentative approval.

Source http://money.cnn.com/