Resolving a contractual dispute dating to 2010 regarding three-way collaboration on Opana ER tablets — between Impax Laboratories, Endo International PLC and Penwest Pharmaceuticals — Impax recently revealed a mutual settlement agreement from its Hayward, California hub.
The resolution relates to the original formulation of Opana ER (oxymorphone hydrochloride) CII Extended-Release tablets.
In 2010, the three entities first entered an agreement regarding an Abbreviated New Drug Application (ANDA) for Opana ER by which Impax acquired a non-exclusive license to particular Endo patents. Certain patents were listed by the Orange Book as belonging to Endo effective through late 2029.
The new agreement modifies the 2010 settlement by stipulating that Impax will pay Endo royalties as of Jan. 1, 2018, with continuation of such payments dependent on commercial conditions. The details were not disclosed, but the royalty rate will divide Impax’s gross profits from oxymorphone hydrochloride CII ER products.
"We are pleased to have reached an agreement to settle this outstanding contractual litigation," Paul Bisaro, president and CEO of Impax, said. "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."
Oxymorphone hydrochloride ER tablets are prescribed for management of severe pain when alternate treatments prove insufficient.
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