Teva Pharmaceutical Industries Ltd. announced that it has commercially shipped Bupropion Hydrochloride Extended-Release tablets, 300 mg, the generic version of Biovail Corporation's antidepressant Wellbutrin XL tablets, pursuant to an agreement with Impax Laboratories, Inc. and Anchen Pharmaceuticals, Inc.
Wellbutrin XL tablets, 300 mg, marketed by GlaxoSmithKline, had US sales of approximately $972 million for the 12 months ended September 2006, according to IMS data, a Teva press release stated..
Under the agreement, Anchen has taken the regulatory steps necessary to permit Impax to obtain final US Food and Drug Administration approval of Impax's Bupropion Hydrochloride Extended-Release tablets, 300 mg and for Teva to sell the product within Anchen's 180-day exclusivity. In return, Anchen will receive certain payments, both during and after the exclusivity period. Pursuant to Teva's existing strategic alliance agreement with Impax, Teva has US marketing rights to Impax's version of this product. Teva will record the revenues resulting from sales of the product and remit payments to Anchen and a negotiated percentage of its gross profit to Impax.
Anchen and Impax are currently in patent litigation concerning this product. Suits were brought against them by Biovail Laboratories International SRL involving their Paragraph IV certifications to US Patent No. 6,096,341. Anchen has been granted summary judgment of non-infringement with regard to its product. Impax has filed a motion for summary judgment of non-infringement.
Anchen was the first generic applicant to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV patent challenge on the patents related to the Wellbutrin XL tablet product and consequently was granted 180 days exclusivity, which it has now transferred to Impax.