1. Generics Bulletin

Generic And Branded Mifepristone Remain On US Market Following Supreme Court Stay

No New Restrictions Will Be Placed On The Drug As Court Cases Play Out

 
• By Chloe Kent

GenBioPro will be able to continue selling its generic mifepristone, after the Supreme Court overruled a stay from the Fifth Circuit which could have seen generic approval rescinded and significant restrictions placed on the drug’s use. 

US Supreme Court building facade with words Equal Justice
A stay from the Fifth Circuit would have suspended GenBioPro's ANDA, but this has been overruled by a stay from the Supreme Court

The US Supreme Court on Friday temporarily blocked lower court orders that would have imposed new restrictions on mifepristone, the first drug taken during a medical abortion, preserving access to both generic and branded versions.

The Court of Appeals for the Fifth Circuit initially granted a limited stay to the original court order, which would have withdrawn approval for GenBioPro’s generic mifepristone to be sold

Turbulence In Court

Justice Clarence Thomas and Justic Samuel Alito were the only two Supreme Court judges who opposed granting a stay. Alito issued a provocative dissent in which he alleged that “the government has not dispelled legitimate doubts that it would even obey an unfavorable order [against mifepristone], much less that it would choose to take enforcement actions to which it has strong objections.” (Also see "Supreme Court’s Stay Of Mifepristone Ruling Gives FDA Respite For Next Round" - Pink Sheet, 22 April, 2023

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