Teva Pharmaceutical Industries Ltd. announced that it has entered into an agreement with Alpharma Inc. pertaining to pending Abbreviated New Drug Applications (ANDAs) for gabapentin 600 mg and 800 mg tablets, and gabapentin 100 mg, 300 mg and 400 mg capsules, the bioequivalent versions of Pfizer's Neurontin Tablets and Neurontin Capsules. Neurontin Tablets and Neurontin Capsules had U.S. sales of over $2 billion for the twelve-month period ended December 31, 2003 according to IMS.
Alpharma holds a final ANDA approval for its gabapentin capsules and is awaiting final ANDA approval for the tablets. Teva Pharmaceuticals USA, Inc. (Teva USA) currently holds tentative approvals for both the tablets and the capsules. The parties believe that the Alpharma ANDAs for the products are entitled, under the Hatch-Waxman Act, to a 180-day period of marketing exclusivity, although another generic manufacturer has challenged these rights in litigation pending in a U.S. District Court. Patent litigation is pending with Pfizer on these products.
Under the terms of the agreement, Alpharma will permit Teva USA to launch its gabapentin within Alpharma's exclusivity period, and Teva will make certain payments, based on Teva USA's sales, to Alpharma relating to the period of exclusivity. In addition, the parties have agreed to certain risk sharing arrangements relating to patent litigation risks regarding a gabapentin launch.
Israel Makov, president and CEO of Teva, commented: "We are pleased to enter into this agreement with Alpharma. We believe that this agreement will facilitate the introduction of the generic version of this important product and thereby significantly reduce its cost to the U.S. consumer."