Ortho-McNeil Pharmaceutical Inc has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Ortho Tri-Cyclen (norgestimate / ethinyl estradiol) Tablets. The application is based on a clinical trial involving approximately 120 adolescent female patients with anorexia nervosa, to study the effects of a hormonal therapy on bone mineral density. Ortho-McNeil conducted this study at the request of the FDA, as part of the pediatric exclusivity provisions of The Best Pharmaceuticals for Children Act.
If approved, the NDA would result in an additional six months of marketing exclusivity for Ortho Tri-Cyclen, whose patent expires on September 26, 2003.
However, under the terms of a patent settlement announced in July 2003 between Barr Laboratories and Ortho-McNeil, Barr will have the right to launch its generic version of Ortho Tri-Cyclen no later than December 29, 2003, if Ortho-McNeil is granted pediatric exclusivity by the FDA.
Anorexia nervosa is a serious, potentially life-threatening illness that affects a growing number of female teenagers in the U.S. Increasingly, this illness is striking patients at younger ages. Many patients with anorexia nervosa experience a number of serious health problems as a result of their condition. For one of these problems, thinning of their bones, or osteoporosis, there is no medication currently approved for treatment.