Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

All generic OxyContin is ADF

Currently none of the ANDA ER Oxycodones are ADFs.

Purdue had the FDA declare that the original OxyContin was removed in 2010 due to safety reasons, and that effectively blocked all non-ADF generic OxyContin. The TEVA and Epic federal appeals court battle with Purdue was over reformulated OxyContin with ADF.

Currently ALL of the ANDA ER Oxycodones are ADFs, but none have been given the ADF Label, probably because they have not been required to submit HAL studies. There are no other generics for any of the other opioids with ADF Label, so there is minimal precedent to go on. It is very likely we will start to see some rules being developed by FDA in near future for how to approach generic ADFs, since they are supposed to have the same ADF features as the reference drug.