>> Orphan status protection at the least. I'm not sure beyond that. <<
An orphan designation applies only to the specified indication (cataplexy) and does not protect off-label competition.
>> I'm not sure this is the type of drug many generics will want… <<
A competitor would have to seek approval in another indication to get around the orphan designation, so we are effectively talking about another branded drug even if it’s the same compound as Xyrem. However, if there is no IP on the composition itself, I don’t think such competition can be ruled out.
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