The court order filing seeks to block the potential launch of generic versions of Niaspan 500mg, 750mg and 1,000mg extended-release tablets (Niacin extended-release tablets) following final FDA approval.
The FDA has tentatively approved Barr’s applications for the three strengths of Niaspan and final approval is anticipated following the expiration on March 30, 2005 of Kos’ 30-month stay under the Hatch-Waxman patent challenge provisions.
“We intend to vigorously oppose all attempts by Kos to limit our options regarding generic Niaspan,” said Bruce Downey, Barr’s chairman and CEO.
Barr’s Niacin 500mg, 750mg and 1,000mg extended-release tablets have tentative approval for use as an adjunct to diet and other non-pharmacologic measures for reduction of elevated cholesterols in patients, when the response to an appropriate diet and other non-pharmacologic measures has been inadequate.