Calliditas Therapeutics AB v. Zydus Pharmaceuticals (USA) Inc. et al

A scheduling order entered April 20, 2026 is the most recent docket activity in Calliditas Therapeutics AB v. Zydus Pharmaceuticals (USA) Inc. et al, No.

1:25-cv-00368. The court held a scheduling hearing the same day and set deadlines and hearing dates for the litigation going forward. No judge has been publicly assigned in the available record.

The case is a Hatch-Waxman patent infringement suit. Calliditas, the branded drug maker, sued Zydus after Zydus filed an Abbreviated New Drug Application seeking approval to sell a generic version of a Calliditas product before the relevant patents expire.

That filing triggered the suit and, under federal law, a 30-month stay that blocks the Food and Drug Administration from approving Zydus's generic while the litigation runs.

The 30-month stay is the commercial clock that matters here. If Calliditas wins before it expires, the stay converts into an injunction. If Zydus wins, or if the stay runs out first, generic entry becomes possible.

The scheduling order suggests the court is moving the case toward a trial-ready posture, though no trial date appears in the available record.

One complication: the internal case record flags this docket as a duplicate of a separate Juryvine entry, case 16660, which covers the same parties and the same docket number. The scheduling order at docket entry 67 appears in both records. That overlap may reflect a logging artifact rather than a distinct legal proceeding, but it means some docket events may be tracked under the other entry.