Cadila Healthcare plans to launch 50 products in US market in FY19

Ahmedabad-based Cadila Healthcare, on the back of a 64 per cent surge in its last financial year’s business in the US, is going strong on boosting its pipeline for the world’s largest single-country drug market.

When an abbreviated new drug application (ANDA) filed with the US Food and Drug Administration (USFDA) contains a paragraph IV certification, the product (when it gets the final approval from the FDA) can be eligible for 180 days of marketing exclusivity.

Under paragraph IV, a company can seek FDA approval to market a generic drug before the patent expires. This involves litigation with the patent holder.

Cadila Healthcare has at least ten para IV filings for the US. As such, the company aims to launch 50 products in the US during the current fiscal year.