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

Of over 140 products in pipeline, at least 10 are para IV filings

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