Shilpa Medicare Files First Transdermal Patch ANDA to USFDA for Rotigotine Transdermal System, USP

Shilpa Medicare Limited, an Indian pharmaceutical company, has filed its Rotigotine 1, 2, 3, 4, 6, 8 mg/24 h transdermal patch USP, ANDA for the US market with the U.S. Food and Drug Administration (USFDA). This marks the company's first-ever transdermal patch submission to the USFDA and is a generic version of the innovator product Neupro®. Shilpa’s product is a pharmaceutical and bioequivalent version of the reference product Neupro®, indicated for treatment of Restless Legs Syndrome and Parkinson’s disease. The total addressable US market for Rotigotine is estimated at USD 112 million. This filing represents a significant milestone for the Company, being Shilpa Medicare’s First transdermal patch dosage form, which is a complex dosage form to be filed in the US market. The once-daily, patient-friendly transdermal formulation ensures reproducible, sustained; and controlled release of medication, enhancing patient compliance. This submission has come from the Company’s finished dosage form manufacturing facility, Shilpa Medicare Ltd, Unit VI, located at Dobbaspet, Bengaluru, Karnataka. Shilpa Medicare Limited is focused on the development, manufacture, and marketing of APIs, formulations, and biologics across oncology, infectious diseases, and specialty segments, serving patients in over 80 countries.