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Mirum Files Patent Suits to Block Livmarli Generics

Story Highlights
  • In November 2025, Mirum received multiple Paragraph IV notices for planned generic versions of Livmarli.
  • On December 19, 2025, Mirum sued the ANDA filers, triggering a 30-month FDA approval stay and delaying generic competition.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Mirum Files Patent Suits to Block Livmarli Generics

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The latest update is out from Mirum Pharmaceuticals ( (MIRM) ).

In November 2025, Mirum Pharmaceuticals received Paragraph IV certification notice letters from multiple generic drug makers, including Sandoz, Annora Pharma, Zydus Lifesciences Global FZE and Zenara Pharma, indicating that these companies had filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration seeking approval to market generic versions of Livmarli (maralixibat). On December 19, 2025, Mirum responded by filing patent infringement lawsuits in the U.S. District Court for the District of Delaware, alleging infringement of its Orange Book-listed patents for Livmarli and securing an automatic 30‑month stay that prevents the FDA from granting final approval of the ANDAs, temporarily protecting Mirum’s market exclusivity for its flagship liver disease therapy and delaying potential generic competition.

The most recent analyst rating on (MIRM) stock is a Buy with a $140.00 price target. To see the full list of analyst forecasts on Mirum Pharmaceuticals stock, see the MIRM Stock Forecast page.

Spark’s Take on MIRM Stock

According to Spark, TipRanks’ AI Analyst, MIRM is a Neutral.

Mirum Pharmaceuticals shows promising revenue growth and strategic expansion through mergers, but faces challenges with profitability, high leverage, and a patent dispute. The technical indicators suggest bearish momentum, and the valuation reflects ongoing financial struggles.

To see Spark’s full report on MIRM stock, click here.

More about Mirum Pharmaceuticals

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing therapies for rare liver diseases, including its marketed product Livmarli (maralixibat), which targets cholestatic liver conditions.

Average Trading Volume: 666,357

Technical Sentiment Signal: Buy

Current Market Cap: $3.57B

For a thorough assessment of MIRM stock, go to TipRanks’ Stock Analysis page.

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