OxyContin Patent Settlement Limits Impax Market Share Even With ANDA Approval
This article was originally published in The Pink Sheet Daily
Generic manufacturer could begin selling either its own product or an authorized generic of the controlled-release opioid as early as Jan. 1, 2016.
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Federal Circuit finds four OxyContin patents invalid, but authorized generics will continue to be only ones available for the near future.
The sponsor believes its data package could support a labeling claim that the drug “is expected to result in a meaningful reduction in abuse”; the agency’s review could indicate the strength of data needed to support such a claim.
OxyContin’s method of treatment patent expires April 16, but several patents remain tied up in litigation over APIs as Purdue and generic companies await FDA decision on whether the original formulation can be a reference product.