Mumbai-based Glenmark Pharmaceuticals is looking to strengthen its position in the world’s largest drug market by launching more generic copies. The company, which owns a strong drug molecule pipeline, is in the process of filing a large number of ANDAs (Abbreviated New Drug Applications) with the US Food and Drug Administration (FDA).
Glenmark’s US formulations business, with sales of $ 335 million in FY14, contributes 34% to its consolidated revenues, thanks largely to the launch of about 58 copycat drugs in the US over the past five years.
The company had 49 ANDAs from financial year 2013 through the first half of FY-15 and has four more ANDAs in the pipeline for the third quarter of FY15. In all, Glenmark is awaiting USFDA approval for 72 ANDAs, of which about 30 ANDAs are paragraph IV ANDAs (which challenge existing drug patents).
“Increased ANDA filing intensity and focus on differentiated dosage forms should help Glenmark’s ANDA filing intensity seems to have picked up meaningfully over the past 2.5 years, after hitting the lowest filing rates during FY10-12,” a recent report from India Infoline research pointed out.
More than 50% of the current filings comprise differentiated products and dosage forms such as oral contraceptives, dermatology products, modified release products, immunosuppressant and oncology injectables.