Register for Generic version of Ortho Tri-Cyclen released
ContraceptionJanuary 29, 2004
2004 JAN 29 - (NewsRx.com & NewsRx.net) -- Barr Laboratories, Inc., (BRL) announced that it has begun shipping its generic version of Ortho-McNeil Pharmaceutical's Ortho Tri-Cyclen oral contraceptive.
The company is marketing its product under the Tri-Sprintec trademark.
On July 31, 2003, the company announced that it had reached a settlement of pending litigation regarding Ortho-McNeil Pharmaceutical, Inc.'s patents protecting Ortho Tri-Cyclen oral contraceptive. Under the terms of the settlement, Barr was permitted to introduce a generic on December 29, 2003, even if the U.S. Food and Drug Administration (FDA) granted pediatric exclusivity for Ortho-McNeil's application for pediatric exclusivity, which it did on December 18, 2003. As a result of the settlement, Barr will be able to enter the market approximately 3 months earlier than otherwise would have been permitted.
"The approval and launch of our Tri-Sprintec oral contraceptive product represents a significant financial opportunity for Barr and increases our current portfolio of generic oral contraceptive to 18 products that compete in the $3.1 billion contraceptive marketplace," said Bruce L. Downey, Barr's chairman and CEO. "Our ability to gain approval for and launch a full line of generic oral contraceptives, as well as our novel Seasonale extended-cycle oral contraceptive that was launched this fall, underscores our commitment to women's healthcare and demonstrates our strengths as a leading developer, manufacturer and packager of oral contraceptive products."
Ortho Tri-Cyclen is a regimen of oral contraceptives that includes three different tablet combinations of norgestimate and ethinyl estradiol 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 had annual sales of approximately $716 million for the twelve months ending October 2003. This article was prepared by Women's Health Weekly editors from staff and other reports. Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net.
©Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net
