Barr Laboratories Inc has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration (FDA) for Eli Lily's Evista 60mg Tablet (raloxifene hydrochloride). Barr's ANDA alleges that the Orange Book listed patents for Evista are invalid or would not be infringed by Barr's ANDA Product. Eli Lilly disclosed in its SEC form 10-Q that Barr had filed an ANDA challenging the patents and that Lilly intends to defend the patents.
Evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women. Evista has current annual sales of approximately $635 million.
Barr filed an ANDA for Raloxifene Hydrochloride 60 mg tablets with the U.S. Food and Drug Administration (FDA) in June 2002, and notified Lilly of the application's acceptance for filing in October 2002.