Endo Pharma has filed lawsuit on 4 March 2010, following Watson’s filing of an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for seeking approval to market its product in the 5, 7.5, 10, 15, 20, 30 and 40mg dosage strengths.
As per the terms of the settlement agreement, Endo has granted Watson a royalty-free license to US patents covering Opana ER.
Additionally, Watson will have the right to launch its generic equivalent version of the product on 15 September 2012 or earlier under certain circumstances.