- Federal government must find alternatives to rescheduling hydrocodone combination drugs
- Actavis launches generic version of Opana ER
- Actavis seeks approval for generic opioid-dependence drug
- FDA to recommend rescheduling of opioid painkiller hydrocodone from CIII to CII
- Mallinckrodt to acquire Cadence Pharmaceuticals
PARSIPPANY, N.J. — Actavis and Mallinckrodt have reached a settlement concerning the former's generic version of an opioid painkiller made by the latter, Actavis said Thursday.
The companies settled patent lawsuit regarding Actavis' generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride) extended-release tablets in the 32-mg strength. The companies settled litigation regarding the 8-mg, 12-mg and 16-mg strengths last month.
Under the settlement, Mallinckrodt granted Actavis a loyalty-free license to its U.S. patents on Exalgo, allowing Actavis to start selling the 32-mg strength in generic form starting in May 2014. Actavis said it was likely the first company to file for Food and Drug Administration approval of a generic version of the drug, which would entitle it to 180 days in which to compete exclusively against the branded version after approval.