Barr Laboratories Inc has initiated a challenge of the patent protecting Ortho-McNeil Pharmaceutical Inc's Ortho Tri-Cyclen Lo oral contraceptive.
Ortho Tri-Cyclen Lo contains 25 mcg of estrogen (ethinyl estradiol) and a tri-phasic regimen of the progestin (norgestimate) and is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. The product comes in 28-tablet packaging. The product was launched in September 2002 and based on IMS data for the most current three months, had annualized sales of approximately $110 million.
Barr filed an Abbreviated New Drug Application (ANDA) for Ortho Tri-Cyclen Lo oral contraceptive with the U.S. Food and Drug Administration (FDA) in June 2003, and received notification of the application's acceptance for filing in August 2003. Following receipt of notice from FDA, Barr notified Ortho-McNeil. On October 1, 2003, Ortho-McNeil filed suit in U.S. District Court for the District of New Jersey to prevent Barr from proceeding with the commercialization of this product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.