On December 20, 2024, the US Court of Appeals for the Federal Circuit released its opinion in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal ...

Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA), ...

Patentees and sponsors of New Drug Applications (NDAs ... which permits Teva to market and sell an inhaler device that administers the API albuterol sulfate. Teva listed several patents in ...

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The manufacturers' reported dose per actuation for both MDIs is 108 µg of albuterol sulfate, which corresponds ... temperature on the performance of the inhalers when not allowed to return ...

A New Jersey district court correctly ruled that the patents, which cover the device’s components, were improperly listed in the FDA’s Orange Book because they don’t claim the drug’s active ingredient ...