Drug: Climara (estradiol)
Company: Bayer HealthCare
Indication: Moderate-to-severe hot flashes
Expiration Date: June 29
Scoop: Although the patent covering Climara expires this year, Mylan has sold a competitor for a number of years. Berlex Laboratories (now part of Bayer) and 3M Pharmaceuticals submitted a citizen petition asking the FDA not to recommend Mylan's estradiol transdermal system as a generic substitute to the Climara system, which is used to reduce moderate-to-severe hot flashes in menopausal women. The companies said Mylan's product wasn't bioequivalent when applied to the buttocks (the product is approved when applied to the buttocks and abdomen). The agency denied the petition in 2004. The '261 patent expires June 29.