Impax announces settlement of contract litigation on Opana ER CII Extended-Release tablets
Contract dispute relates to an agreement entered into among Endo International, Penwest Pharmaceuticals and Impax.
Impax Laboratories has announced a Settlement Agreement to resolve a contract dispute relating to an agreement entered into in June 2010 among Endo International, Penwest Pharmaceuticals and Impax regarding the Abbreviated New Drug Application (ANDA) litigation related to the original formulation of Opana ER (oxymorphone hydrochloride) CII Extended-Release (ER) tablets. In the 2010 ANDA Settlement, Impax obtained a non-exclusive license to certain then-existing and future Endo patents. Orange Book listed patents for Opana ER extend until November 2029.
The Contract Settlement Agreement includes an amendment to the 2010 ANDA Settlement, whereby Impax agrees to pay Endo a royalty rate that splits Impax's gross profits for its sales of oxymorphone hydrochloride CII ER products, commencing 1 January 2018. The royalty will be eliminated based on certain commercial conditions. Further terms of the settlement were not disclosed.
"We are pleased to have reached an agreement to settle this outstanding contractual litigation," said Paul Bisaro, President and Chief Executive Officer of Impax. "We will continue to make available our generic version of original Opana ER (oxymorphone hydrochloride) CII ER tablets for prescribing physicians that prefer this product to treat patients."
Combined reported net sales of Endo's new formulation of Opana ER and Impax's generic oxymorphone hydrochloride ER tablets (AB-rated to original formulation of Opana ER) were $229 million for the last 12 months ended 31 March 2017.
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