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On November 17, 2025, Mirum Pharmaceuticals, Inc. (the "Company") received a Paragraph IV Certification Notice Letter (the "Notice Letter") from Sandoz, Inc. ("Sandoz") providing notification to the Company that Sandoz has submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA") seeking approval to manufacture, use or sell a generic version of Livmarli® (maralixibat).
In the Notice Letter, Sandoz alleges that five of the patents listed in the FDA Orange Book for Livmarli, U.S. Patent Numbers 11,229,647, 11,260,053, 11,376,251, 11,497,745 and 11,918,578, are invalid, unenforceable or will not be infringed by Sandoz's manufacture, use or sale of the generic product described in its ANDA submission.
Under the Food and Drug Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, after receipt of a valid Paragraph IV Notice Letter, the Company may bring a patent infringement suit against Sandoz. If such suit is commenced within 45 days of receipt of the Notice Letter, this triggers an automatic 30-month stay, which would prevent the FDA from issuing final approval of Sandoz's ANDA until the expiration of the stay.
The Company expects to receive additional Paragraph IV Certification Notice Letters in the future from ANDA filers seeking approval of a generic version of Livmarli.
The Company intends to vigorously defend and enforce its intellectual property rights relating to Livmarli and plans to promptly file a patent infringement suit against Sandoz and any other ANDA filer with respect to Livmarli, seeking, among other remedies, a permanent injunction to prevent such parties from introducing a generic version of Livmarli that would infringe the Company's patents.
Posted In: MIRM
