Barr Pharmaceuticals Inc announced that its subsidiary, Barr Laboratories, Inc. and Eli Lilly & Company voluntarily stipulated that all claims asserted by Lilly against Barr and all counterclaims asserted by Barr against Lilly in the patent litigation between the two parties related to Lilly's Prozac Weekly (Fluoxetine Hydrochloride) Capsules, USP 90 mg have been dismissed.
The patent litigation had been initiated in May 2006 when Lilly sued Barr seeking to protect its Prozac Weekly product from generic competition. Barr indicated it believes it is the first to file an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for the 90 mg capsule product and, consequently, will be entitled to 180 days exclusivity when its ANDA receives FDA approval.
Barr filed an ANDA for Fluoxetine Hydrochloride capsules, USP 90 mg with the FDA in September 2001, and received notification of the application's acceptance for filing in November 2001. Barr's ANDA contained a Paragraph IV certification to the patents listed in the orange book for this product. Following receipt of notice from FDA, Barr notified Lilly of its ANDA filing.
Lilly did not sue Barr within 45 days of receiving this notice. On March 21, 2006, Lilly obtained a reissue patent, US Patent RE39,030, and subsequently listed that patent in the orange book. Barr amended its ANDA to include a Paragraph IV certification to that patent. On May 10, 2006, after receiving notice from Barr, Lilly filed suit against Barr on the reissue patent in the US district court, southern district of Indiana, to prevent Barr from proceeding with the commercialisation of this product. On June 1, 2007, Barr and Lilly voluntarily dismissed all claims and counterclaims in the patent litigation.
Prozac Weekly is indicated for the continuation treatment phase of major depressive disorder. Prozac weekly capsules, USP 90 mg has current annual sales of approximately $30 million, based on IMS sales data for the twelve months ended March 2007.