Shilpa Medicare Enters US Transdermal Market, Files First ANDA for Rotigotine Patch
New Delhi: Shilpa Medicare Limited has informed stock exchanges that it has filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (USFDA) for its Rotigotine transdermal patch in strengths of 1, 2, 3, 4, 6 and 8 mg/24 hours for the US market.
The disclosure was made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
The ANDA filing marks a significant milestone for the Raichur-headquartered pharmaceutical company, as it represents Shilpa Medicare’s first-ever transdermal patch submission to the USFDA. The application is for a generic version of Neupro®, the innovator rotigotine transdermal system, and Shilpa stated that its product is both pharmaceutical and bioequivalent to the reference listed drug.
Rotigotine transdermal patches are indicated for the treatment of Restless Legs Syndrome and Parkinson’s disease. According to the company, the total addressable market for rotigotine in the United States is estimated at approximately USD 112 million, highlighting the commercial potential of the filing.
Shilpa Medicare noted that the once-daily transdermal formulation is designed to ensure reproducible, sustained and controlled delivery of the drug, which can help improve patient compliance. Transdermal patches are considered complex dosage forms, and the successful filing underscores the company’s growing capabilities in advanced drug delivery technologies.
The ANDA has been filed from Shilpa Medicare’s finished dosage form manufacturing facility, Unit VI, located at Dobbaspet, Bengaluru, Karnataka. The facility is involved in the manufacturing, packaging, labelling and testing of specialised finished dosage forms, including oral mouth-dissolving films and transdermal patches. The unit has approvals from both European regulators and the USFDA.
Shilpa Medicare Limited, listed on the BSE and NSE, is engaged in the development, manufacture and marketing of active pharmaceutical ingredients, formulations and biologics across oncology, infectious diseases and specialty segments. The company has a strong focus on complex generics, novel drug delivery systems and contract development and manufacturing services, with operations spanning more than 80 countries worldwide.
