Oxandrin is an oral therapy used to promote weight gain following extensive surgery, chronic infection, or severe trauma. Oxandrin is also indicated for patients who, without definite reason, fail to gain or maintain normal weight.
The suit was brought in response to Barr’s filing of an abbreviated new drug application with the FDA seeking approval to engage in the commercial manufacture of oxandrolone tablets prior to expiration of Oxandrin patents.
Barr said it believed it was the first company to apply for an abbreviated new drug application for Oxandrin.
We are determined to take the actions necessary to defend our patent rights relating to the use of Oxandrin. We believe our patent position is strong and anticipate a favorable outcome, said Christopher Clement, president and CEO of Savient Pharmaceuticals.