Teva Files NDA with U.S. FDA for Generic Qsymia
Teva Pharmaceuticals USA, Inc has filed with the U.S. Food and Drug Administration, or the FDA, an Abbreviated New Drug Application, or ANDA, for generic versions of all strengths of Qsymia (phentermine and topiramate extended release) capsules CIV.
The notice from Teva included a paragraph IV certification with respect to eight of the Company’s patents listed in the FDA’s Orange Book on the date of the Company’s receipt of the notice. A paragraph IV certification is a certification by a generic applicant that patents covering the branded product are invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of the generic product.
The Company is currently reviewing the details of Teva’s notice. Under the Hatch-Waxman Act, the Company has 45 days from receipt of the notice to determine if it will file a patent infringement suit. If the Company brings such a suit, a stay of approval of up to 30 months will be imposed by the FDA on Teva’s ANDA. The Company intends to vigorously enforce its intellectual property rights, but cannot predict the outcome of this matter.