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

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Case Summary

Calliditas Therapeutics AB filed suit against Zydus Pharmaceuticals (USA) Inc. and co-defendants under docket 25-cv-00368, a recently filed action. The case follows the Hatch-Waxman pattern, with Calliditas defending its branded pharmaceutical product against a generic challenger's abbreviated new drug application. The docket entry reflects a scheduling order setting deadlines and hearings at entry 67. The case is in active pretrial management, with no dispositive rulings yet on record.

Latest development

1:25-cv-00368 Calliditas Therapeutics AB v. Zydus Pharmaceuticals (USA) Inc. et al

Hearing · April 20, 2026

A scheduling hearing was held in Calliditas Therapeutics AB v. Zydus Pharmaceuticals (USA) Inc., Case No. 1:25-cv-00368, setting deadlines and hearing dates for the litigation. These administrative orders control the pace of the case — missed deadlines here carry real consequences, including potential sanctions or waived arguments.

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Key Issues

• • Hatch-Waxman patent infringement
• • Generic entry and 30-month stay
• • Pretrial scheduling and case management

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1 event

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Hearing 4 hours ago

A scheduling hearing was held in Calliditas Therapeutics AB v. Zydus Pharmaceuticals (USA) Inc., Case No. 1:25-cv-00368, setting deadlines and hearing dates for the litigation. These administrative orders control the pace of the case — miss

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~Util - Set Deadlines/Hearings ( 67

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Case Timeline

1 event

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Hearing April 20, 2026

1:25-cv-00368 Calliditas Therapeutics AB v. Zydus Pharmaceuticals (USA) Inc. et al

A scheduling hearing was held in Calliditas Therapeutics AB v. Zydus Pharmaceuticals (USA) Inc., Case No. 1:25-cv-00368, setting deadlines and hearing dates for the litigation. These administrative orders control the pace of the case — missed deadlines here carry real consequences, including potential sanctions or waived arguments.

description View filing open_in_new

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Press Coverage

1 article

All No paywall (1) Original reporting (1)

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Coverage

1:25-cv-00368 Calliditas Therapeutics AB v. Zydus Pharmaceuticals (USA) Inc. et al

~Util - Set Deadlines/Hearings ( 67

Apr 20, 2026 · 1 min read