US Judge Denies Covidien Effort To Block Generic Sleep Drug
August 05 2009 - 3:51PM
Dow Jones News
A U.S. judge has denied an attempt by Covidien Ltd. (COV) to
stop private drug maker URL Pharma Inc. from launching a low-dose
generic version of Covidien's insomnia drug Restoril well before
the drug's patent expires next May.
URL filed an application with the U.S. Food and Drug
Administration on Nov. 1, 2006, seeking approval to make and sell
the drug, which is known generically as temazepam.
A 30-month stay on FDA approval of that application is set to
expire Aug. 12, but Covidien - which had sued for patent
infringement - asked the U.S. District Court for the District of
New Jersey for a preliminary injunction that would stop URL from
launching when the stay lifts.
In a ruling dated Tuesday, Judge Stanley R. Chesler denied
Covidien's motion while also ruling against Covidien's infringement
claim.
At issue is a 7.5 milligram generic version of Restoril, which
is the smallest of four available doses. Restoril is not a major
product for Covidien, where it represents 4% to 5% of drug sales,
said Coleman N. Lannum, vice president of investor relations,
during a BMO Capital Markets health-care conference on
Wednesday.
Drug sales also represent about 10% of Covidien's total sales,
spokesman Bruce Farmer noted. Regarding Judge Chesler's ruling,
Lannum said "we're going to take a look and defend that any way we
can."
A spokesperson for URL Pharma wasn't available for immediate
comment.
Generic versions of Restoril are already on the market. Mylan
Inc. (MYL) announced in June that it had gained FDA approval to
sell the 22.5 milligram dose. It already marketed 15 milligram and
30 milligram doses.
Shares of Covidien slipped 0.9% to close at $38.69 on
Wednesday.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com