Glenmark Pharmaceuticals launches Rufinamide Tablets in US
Glenmark Pharmaceuticals said that it has launched Rufinamide Tablets USP, 200 mg and 400 mg in the US, which is a therapeutic equivalent of Banzel Tablets, 200 mg and 400 mg owned by Eisai.
Banzel is indicated for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS).
The Indian pharma company said that it was among the first ANDA applicants to submit a significantly complete ANDA for Rufinamide Tablets USP, 200 mg and 400 mg, with a paragraph IV certification and had secured final approval in May 2016.
Sanjeev Krishan – President, Glenmark North America said: “We are very pleased to be one of the first generic companies in the US to offer lower cost alternative to Banzel Tablets, 200 mg and 400 mg. The launch is our commitment to provide quality and affordable healthcare to our markets for patients.”
Banzel Tablets, 200 mg and 400 mg market had recorded annual sales of around $285.3 million, as per IQVIATM sales data for the 12-month period ending April 2021.
The current portfolio of Glenmark Pharmaceuticals has 172 products authorized for distribution in the US and 45 ANDA’s pending approval with the US Food and Drug Administration.
Apart from the internal filings, the Indian pharma company said that it continues to identify and explore external development partnerships for supplementing and expediting the growth of its existing pipeline and portfolio.