FDA’s Approval of Generic Version of Jazz Pharma’s Sleep Disorder Drug Raises Questions

Posted 18 January 2017 | By Zachary Brennan 

FDA’s Approval of Generic Version of Jazz Pharma’s Sleep Disorder Drug Raises Questions

The US Food and Drug Administration (FDA) late Tuesday approved a generic version of Jazz Pharmaceuticals’ Xyrem (sodium oxybate) to help treat a sleep disorder but at least one investment analyst thinks the move could lead to a slippery slope of companies adding drug-drug interaction (DDI) patents and using them to keep generics from entering the market.

In addition to granting approval to the generic, FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for the generic with both similarities and differences to the reference product.

FDA also signed off on Jazz’s Citizen Petition yesterday, focusing its attention on what’s known as a labeling “carve out,” which in this case is information pertaining to the DDI between Xyrem and divalproex sodium and related dose reduction instructions, which Jazz claimed is protected by patent.

In the petition, FDA says it “will not approve any sodium oxybate ANDA referencing Xyrem as the RLD [reference listed drug] that does not include in its labeling the portions of the currently approved Xyrem package insert related to the DDI with divalproex sodium.”

Berstein analyst Ronny Gal told investors on Wednesday that this move could open the door for other pharmaceutical companies to patent similar DDIs and keep generics at bay.

“What Jazz did with Xyrem was to study in details the drug-drug interaction of its drug, patent that knowledge and then add specific language to its label addressing the issue,” Gal explained. “FDA has now blessed this approach. As almost all drugs (certainly psychoactive drugs) have some drug-drug interaction, this approach can be applicable to almost all drugs. FDA's decision now opened the door to easily deployable patent extension strategy of old drugs.” 

FDA approves a generic of Xyrem with a REMS Program

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