Mirum receives Sandoz Paragraph IV notice challenging Livmarli patents; plans to sue

Mirum Pharmaceuticals, Inc.

Sandoz filed ANDA seeking FDA approval for generic Livmarli (maralixibat).
Sandoz alleges five Livmarli Orange Book patents are invalid or not infringed.
Mirum has 45 days to sue, triggering a 30-month FDA approval stay.
Mirum expects additional Paragraph IV notices from other ANDA filers.
Company vows to vigorously enforce IP and seek a permanent injunction.

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