Mylan Pharmaceuticals, Inc. v. U.S. Food and Drug Administration
United States Court of Appeals for the Fourth Circuit
454 F.3d 270 (2006)
Mylan Pharmaceuticals (Mylan) (plaintiff) filed the first paragraph IV ANDA for a generic version of Proctor & Gamble's (P&G) patented drug Macrobid and received FDA approval, but when Mylan began selling its generic, a third party licensed by P&G began selling a competing generic during Mylan's supposed 180-day exclusivity period, significantly cutting into Mylan's revenues. Mylan petitioned the FDA (defendant) to bar the licensed generic from selling until Mylan's 180 days had run; the FDA denied the petition, the district court dismissed Mylan's resulting suit (relying on a similar ruling in another case), and Mylan appealed.
Whether the 180-day period of exclusivity afforded to generic drug makers precludes pioneer drug manufacturers from making licensing agreements with third parties to sell generic versions of a brand-name drug.