Shilpa Medicare gets key European authorization for Rotigotine patch

Shilpa Medicare Limited has received initial authorization from Europe for its Rotigotine 1, 2, 3, 4, 6, 8 mg/24 h transdermal patch. This authorization recommends the grant of final Marketing Authorization for the prescription product, a generic version of the innovator product Neupro®. The patches are indicated for the treatment of Restless Legs Syndrome and Parkinson's disease.

The European market for Rotigotine is estimated at approximately $222 million. Shilpa Medicare has partnered with a strategic commercialization partner in Europe, targeting a launch in FY27. This marks the company's first transdermal patch dosage form to receive marketing authorization in the European region.

The approval stems from Shilpa Medicare's finished dosage form manufacturing facility in Dobbaspet, Bengaluru, Karnataka. This facility specializes in manufacturing, packaging, labeling, and testing of specialized finished dosage forms, including oral dispersible/dissolving films and transdermal patches.