Shilpa Medicare has filed an ANDA with the USFDA for its Rotigotine transdermal patch, a generic version of Neupro®. This marks Shilpa’s first transdermal patch submission to the USFDA. The Rotigotine patches are indicated for treating Restless Legs Syndrome and Parkinson’s disease. The total addressable US market for Rotigotine is estimated at USD 112 million.
Transdermal Patch ANDA Filing
Shilpa Medicare has announced the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (USFDA) for its Rotigotine transdermal patch. This is a generic version of the reference product, Neupro®.
Product Details and Market Potential
The ANDA is for Rotigotine transdermal patches in various strengths (1, 2, 3, 4, 6, 8 mg/24 h). The drug is 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.
Manufacturing and Regulatory Approval
This represents Shilpa Medicare’s first transdermal patch dosage form filing in the US market. The manufacturing facility located at Dobbaspet, Bengaluru, Karnataka is approved by both Europe and the USFDA for the manufacture and testing of transdermal systems and oral mouth dissolving films.
Source: BSE
