ANDRX LATE TO FILE FIRST PARAGRAPH IV FOR CONCERTA
It appears that generic drugmaker Andrx was a day late in its bid to secure marketing exclusivity for its generic version of Johnson & Johnson's (J&J) lucrative attention-deficit/hyperactivity disorder treatment Concerta.
Andrx filed a Paragraph IV certification with the FDA July 20 relating to a newly listed patent on Concerta (methylphenidate HCl), but the company recently learned that a competing firm had filed its Paragraph IV one day earlier. The patent in question, issued to J&J subsidiary Alza, is the first Concerta patent listed in the FDA's Orange Book. The patent was recently listed by the FDA.
Andrx, which had already started ramping up pre-launch inventories of its Concerta generic, was forced to take a $4.1 million charge against its second-quarter earnings for pre-launch inventory that may be out-of-date by the time it can start selling its drug.
In other news, Andrx said a preliminary injunction hearing has been scheduled for Sept. 6 to resolve issues surrounding Andrx's generic version of Abbott's Biaxin XL (clarithromycin).
In May, Abbott and Andrx entered into a restraining order agreement that prohibits Andrx from selling its generic version of Biaxin XL in the U.S. until a ruling is entered on Abbott's motion for a preliminary injunction in the case.