Apotex Sues Lilly to Grease Path for Forteo Bone-Loss Drug Copy

December 6, 2022, 10:41 PM UTC

Apotex Inc. asked a federal court to declare that its proposed copy of Eli Lilly & Co.’s osteoperosis drug Forteo doesn’t infringe a patent for its injection device, seeking to speed up regulatory approval by six months.

The patent, which expires in March 2025, is the only one listed in the US Food and Drug Administration’s entry for Forteo in its registry of approved drugs, the Orange Book.

The first generic-drug maker to apply for FDA approval of a copy of a name-brand drug gets 180 days during which no other generic version of the drug can be approved, ...

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