Shilpa Medicare has filed its Rotigotine 1, 2, 3, 4, 6, 8 mg/24 h transdermal patch USP, ANDA for US market, marking its first-ever
transdermal patch submission to the U.S. Food and Drug Administration (USFDA).
This application submitted as an ANDA with USFDA is a generic version of the innovator product Neupro®. Shilpa' s product is pharmaceutical and bioequivalent version of the reference product Neupro®. Shilpa' s
Rotigotine patches are 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 Filling 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. The facility is involved in manufacturing, packaging, labelling and testing of specialized finished dosage forms as oral dispersible/dissolving Films and Transdermal Patches.