Purdue Moves To Stave Off Branded, Generic Competitors To New OxyContin
Purdue Pharma is looking for assistance from FDA to help protect the company’s OxyContin franchise from both branded and generic competitors.
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Patent Expiration May Not Help OxyContin Generics
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.
FDA’s Opioid To-Do List Could Redefine Pain Market For Brands, Generics
Supporters of narrowing opioid drugs’ non-cancer pain indication tell FDA that pain patients often suffer the consequences of addiction and misuse.
Endo Seeks To Block Generics Of Opana ER That Are Not Crush-Resistant
Endo citizen petition asks FDA to determine that the company’s old formulation was withdrawn for safety reasons and to decline approval of ANDAs of that formulation; Purdue Pharma files third OxyContin citizen petition.