June 22, 2004 - U.S. Food and Drug Administration Applies DURAGESIC(R) Six-Month Period of Pediatric Exclusivity
Janssen Pharmaceutica Products, L.P. announced that the U.S. Food and Drug Administration (FDA) would apply the six-month period of pediatric exclusivity previously granted by the agency to DURAGESIC(R) (fentanyl transdermal system) CII. The decision requires that the effective date of FDA approval of the application of Mylan Laboratories, Inc. for a generic fentanyl transdermal patch be changed to a date after the expiration of the DURAGESIC pediatric exclusivity period in January 2005.
The FDA action follows a recent U.S. District Court ruling by Judge William K. Sessions III in Burlington, Vermont that the generic product from Mylan infringed the DURAGESIC product patent.
DURAGESIC and its active ingredient, fentanyl, are integral parts of Janssen's history. Janssen researchers synthesized fentanyl in 1960 and the FDA approved DURAGESIC in 1990.