Egalet Corp. said in a Form 8-K filing that Apotex Inc. and Apotex Corp. lost the right to launch an authorized generic version of its Sprix nasal spray.
Under a deal with Egalet, Apotex had rights to launch the generic version in March 2018. But the deal required Apotex to inform Egalet on or before Nov. 25 if it wished to exercise the launch option, which Apotex had not done, Egalet said.
If Apotex can meet requirements to launch an unauthorized generic, including getting an U.S. Food and Drug Administration approval of an abbreviated new drug application for its generic, it can launch in September 2018. Canada-based Apotex may also launch the generic six months earlier but it would then have to pay royalties on net sales of the drug from the launch date until December 2018, Egalet said in the filing.
