I thought this was old news, but Dow_Jones Newswire just published it:
Barr Gets Tentative Approval For Generic Niaspan(R) 500 Mg And 750 Mg Extended-Release Tablets
DOW JONES NEWSWIRES
POMONA, N.Y. -- Barr Laboratories Inc. (BRL) received tentative approval from the U.S. Food and Drug Administration for its generic version of Kos Pharmaceutical Inc.'s (KOSP ) Niaspan 500-milligram and 750-milligram extended-release tablets.
Barr, a generic and proprietary pharmaceutical company, said in a press release Monday that it is challenging the validity or infringement of certain patents held by Kos for the tablets. A trial on the matter is scheduled for December 2004.
On May 12, Barr received tentative FDA approval to make and market Niaspan's 1000 mg generic version of the niacin extended-release tablets, which are used to reduce cholesterol in patients when dieting and other nonpharmacologic methods have failed.
Kos, which holds three patents for Niaspan, has sued to prevent Barr from making or marketing the generic version. Kos, Miami, said its Niaspan patent expires in 2013.
Barr said that its Abbreviated New Drug Application for the 500 mg and 750 mg dosages of Niaspan were received by the FDA in April 2002.
Following the receipt of notice from the FDA, Barr notified Kos of its intentions. On Aug. 12, Kos said it had filed suit in a New York federal court to prevent Barr from marketing the products. Barr believes it was the first to put in an FDA application.
Last year, Niaspan 500 mg tablets had sales of $191 million, while the 750 mg tablets accounted for about $20 million.
A Barr spokeswoman was unavailable to comment on the suit. |
