Barr initiates challenge of Ortho Tri-Cyclen patent

Drug Store News, July 17, 2000

Barr Laboratories has initiated a challenge of the patents protecting Ortho-MeNeil's Ortho Tri-Cyclen oral contraceptive. Ortho Tri-Cyclen, a triphasic oral contraceptive that contains three different tablet combinations of Norgestimate and ethinyl estradiol, had 1999 sales of approximately $400 million. It is the only oral contraceptive tablet also indicated for the treatment of moderate acne.

Separately, Barr is currently challenging the patents protecting the Ortho-Novum 7/7/7 oral contraceptive, which has annual sales of approximately $160 million. This separate challenge is expected to go to trial in the first half of calendar year 2001.

Barr filed an ANDA for Ortho Tri-Cyclen with the FDA in February and received notification of the application's acceptance for filing in March. Following receipt of notice from the FDA, Barr notified Ortho-McNeil. On June 8, Ortho-McNeil filed suit in U.S. District Court in New Jersey to prevent Barr from proceeding with the commercialization of the product. The action formally initiates the patent challenge process, Barr said.