U.S. District Court grants Mylan extension for consideration of Amlodipine Besylate exclusivity

Apr 11 2007

Mylan Laboratories has announced that the U.S. District Court for the District of Columbia has extended the deadlines pertaining to Mylan's request for a temporary restraining order in its lawsuit seeking to stop the U.S. Food and Drug Administration (FDA) from approving any other Amlodipine Besylate abbreviated new drug applications (ANDAs).

At the request of the FDA, the court extended the deadlines in its previous order by one week so that the FDA is now enjoined from taking final agency action from April 18th, the date the FDA will notify the parties and the court of its position, until April 20th at 5:00 p.m. In its Motion to Alter Schedule, the FDA stated that it needs more time to review and respond in a meaningful manner to the numerous comments it has received. As previously disclosed, Mylan triggered its 180-day exclusivity period for all strengths of Amlodipine Besylate when it commercially launched the product on March 23rd. In addition, Mylan believes that it has further protection for its current exclusivity based on the pediatric exclusivity previously granted to Pfizer on the '303 patent which serves to block any additional approvals until September 25, 2007, the end of the pediatric exclusivity period. When the '303 patent expired, several valid claims remained, although they were not asserted against Mylan at trial.