FDAnews

EXPERT: MYLAN COULD LAUNCH GENERIC NORVASC DURING PEDIATRIC EXTENSION

Pennsylvania-based drug company Mylan Laboratories could try to capitalize on its first-to-file status for Pfizer's blood-pressure drug Norvasc by launching during the pediatric exclusivity period, according to one analyst.

Launching after patent expiry but during pediatric exclusivity would be a "profitable and lower risk way to monetize the asset," Gregg Gilbert of Merrill Lynch said in a recent note. Pfizer's key patent for Norvasc (amlodipine besylate) expires March 25, 2007, while the pediatric extension expires Sept. 25, 2007. Mylan will not enjoy its full six-month marketing exclusivity for generic Norvasc unless it launches March 25, Gilbert said. A March launch could garner $250 million for Mylan, he said.

Pfizer already has lost the opportunity to obtain a 30-month stay on final approval of Mylan's product. Pfizer did not sue Mylan within the required 45-day notification period to trigger the stay, Gilbert notes. Innovator firms must sue drug patent challengers within 45 days of being notified that an abbreviated new drug application has been filed. The FDA gave final approval to Mylan's Norvasc equivalent in October 2005.