Teva Pharmaceuticals has filed a lawsuit in a U.S. district court against the FDA after being denied the 180-day exclusivity for its generic version of the blockbuster antipsychotic Risperdal. Teva said that it was eligible for the 180-day marketing exclusivity, as it was the first to submit an abbreviated new drug application (ANDA) for Janssen Pharmaceutical’s Risperdal (risperidone) tablets with a Paragraph IV certification for the ’952 patent.

U.K.-based Argenta Discovery has begun the phase II trial of ADC4022 for the treatment of chronic obstructive pulmonary disease (COPD) and steroid-insensitive asthma. The trial will study the effect of inhaled ADC4022 and an inhaled corticosteroid on markers of inflammation and pulmonary function over four weeks. The study is going to be multicenter, randomized, double blind and placebo-controlled.

A U.S. district court has ruled in favor of Barr Pharmaceuticals in a lawsuit challenging the patent listed by Bayer Schering Pharma in connection with Yasmin(R). The judge found the patent for the oral contraceptive as invalid. Yasmin provides an oral contraceptive regimen consisting of 21 active tablets (each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol) and 7 inert tablets.

The FDA has approved a supplemental NDA (new drug application) submitted by Otsuka Pharmaceutical and Bristol-Myers Squibb for Abilify (aripiprazole) to treat manic and mixed episodes related to bipolar I disorder in children between 10 and 17 years of age. The drug already has approval for the treatment of manic and mixed episodes related to Bipolar I Disorder with or without psychotic features in adults.