NEW YORK (AP) – Teva Pharmaceutical Industries Ltd. said it is now selling a generic version of its sleep disorder drug Provigil.
Meanwhile one of Teva’s competitors said it is suing the Food and Drug Administration for keeping its version off the market for six months.
Teva, the world’s largest generic drug company, says the FDA has ruled it is the first company to file applications for two patents covering Provigil, which is used to treat sleep disorders like narcolepsy. Teva said its Cephalon division began selling an authorized generic version of Provigil, or modafinil, on March 29, and the FDA’s decision means competing generics will be barred from the market for six months.
However Par Pharmaceuticals is also allowed to sell its own version, and Teva said it expects Par to do that starting April 6.
Barclays analyst Douglas Taso said the FDA’s decision is good news for Par because with fewer competitors, it will get a larger share of the market for generic Provigil. He said that could add 65 cents per share to its annual profit.
Another large generic drugmaker, Mylan Inc., said it is suing the FDA to get the decision overturned. Mylan said the FDA should have found that Mylan was the first company to file an application on one of the patents and given it the six months of marketing exclusivity. The Pittsburgh company added that Teva controls 100 percent of the supply of generic Provigil and said antitrust regulators did not intend for that to be the case.
Mylan has asked the U.S. District Court for the District of Columbia to file an immediate order granting it marketing approval and exclusivity.
The Federal Trade Commission ordered Teva to sell the U.S. rights to generic Provigil in October as a condition of Teva’s acquisition of Cephalon, the company that developed Provigil. Par acquired those rights from Teva in October.
Par’s deal with Teva also gave Par the U.S. rights to generic versions of the painkiller Actiq and the muscle relaxant Amrix. Par said annual U.S. sales of Provigil are about $1.1 billion.
Date: April 5, 2012
Source: Associated Press
Filed Under: Drug Discovery
