Court rules that Apotex wait three weeks before approval of generic Prilosec

WASHINGTON Apotex will have to wait about three weeks before they can receive renewed approval to market their generic version of the drug Prilosec, according to a district court.

The U.S. District Court for the Southern District of New York had ruled that Apotex’s product infringed on AstraZeneca’s Prilosec patents and that no generic shall be approved or marketed until the pediatric-exclusivity period for the patent expires on Oct. 20th, wrote Judge Ricardo Urbina.

The Food and Drug Administration therefore converted Apotex’s final approval into a tentative approval, which Apotex sued the agency over claiming it violated the Administrative Procedure Act. Apotex lost that case because; it failed to show that it would suffer injury from the lost of the approval.

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