The final approval of the generic 500mg, 750mg and 1000mg Niaspan tablets follows the expiration of Kos’ 30-month stay under the Hatch-Waxman patent challenge provisions and the resolution of the litigation between Barr and Kos regarding the cholesterol-lowering products.
Earlier this month, on April 13, Barr and Kos announced that they had entered into settlement and license, co-promotion, and licensing and manufacturing agreements relating to the resolution of the patent litigation involving Kos’ Niaspan products.
Under the terms of the settlement and license agreement, Barr is permitted to launch generic versions of Niaspan and Advicor, as well as future dosage formulations, strengths or modified versions of the products, under terms of an exclusive license.
In a separate license and manufacturing agreement, Barr agreed to stand ready to supply Kos Life Sciences quantities of Niaspan 500mg, 750mg and 1000mg extended-release Niacin tablets and Advicor 500mg/20mg, 750mg/20mg and 1000mg/20mg extended release Niacin/Lovastatin Tablets, under or pursuant to the approval of Barr’s abbreviated new drug applications (ANDAs).