Shilpa Medicare Limited has announced a significant milestone with the filing of its first Abbreviated New Drug Application (ANDA) for Rotigotine Transdermal System, USP, with the U.S. Food and Drug Administration (USFDA). This filing marks Shilpa Medicare's inaugural transdermal patch submission to the USFDA. The generic version is for the innovator product Neupro®, and Shilpa's product is pharmaceutical and bioequivalent. The Rotigotine patches are indicated for the treatment of Restless Legs Syndrome and Parkinson's disease. The total addressable US market for Rotigotine is estimated at USD 112 million (approximately ₹929 crore). The submission originates from the company's finished dosage form manufacturing facility, Shilpa Medicare Ltd, Unit VI, in Dobbaspet, Bengaluru, Karnataka. This facility, approved by European and USFDA authorities, specializes in manufacturing, packaging, labeling, and testing of specialized finished dosage forms like oral dispersible/dissolving films and transdermal patches. This is a complex dosage form, and its successful filing represents a significant achievement for the company.
