DBT Bureau
Pune, 12 Dec 2025
Shilpa Medicare Limited, headquartered in Raichur, Karnataka, said to the exchange that it has received the Initial Authorization from European authorities recommending the grant of final Marketing Authorization for its prescription product, the Rotigotine 1, 2, 3, 4, 6, 8 mg/24 h transdermal patch. Submitted as a generic application via the Decentralized Procedure in Europe, the product is a pharmaceutical and bioequivalent version of the innovator Neupro® and is indicated for the treatment of Restless Legs Syndrome and Parkinson’s disease. The company noted that the total addressable European market for Rotigotine is estimated at around USD 222 million, and it has already onboarded a strategic commercialization partner in Europe with a targeted FY27 launch.
The company added that this authorization marks a major milestone as Shilpa Medicare’s first transdermal patch dosage form to receive marketing authorization in the European region. The once-daily, patient-friendly formulation ensures reproducible, sustained and controlled drug release, improving patient compliance. The approval was granted from its finished dosage form manufacturing facility, Unit VI at Dobbaspet, Bengaluru—its first European approval for a prescription transdermal dosage form. This facility supports manufacturing, packaging, labelling and testing of specialized finished dosage forms including oral dispersible/dissolving films and transdermal patches.
