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.
Analysts say para IV filings are, thus, crucial as upon getting the FDA approval to launch the generic product as the first company one would enjoy a six-month limited competition period in the US.
For example, Cadila had launched the generic version of ulcerative colitis drug Lialda in the US around July 2017, which enjoyed a 180-day exclusivity. While the period ended in January, Israeli drug firm Teva launched its generic version of the same drug around March. As a result, Cadila enjoyed another 75 days of clear run in the market.
The company clocked $250 million in revenues from generic Lialda during FY18.
Contribution of the US, a key market for the company, to the total revenue grew from 39 per cent in FY17 to 50 per cent in FY18.
“We plan to launch at least 50 products in the US market during FY19. There are over 140 ANDAs pending approval and of this, many are para-IV filings. We already received around 77 approvals last fiscal. Our future launches would be in transdermal, injectables, oral solids etc,” said a senior executive of the company. He did not elaborate on the para IV filings.
Deepak Malik, analyst at Edelweiss Securities, pointed out there were at least ten known para IV filings by the company (see chart). Some of these are oncology drugs — Bristol-Myers Squibb’s Reyata (atazanavir) is an HIV drug, Actelion’s hypertension drug Opsumit for which only another firm has filed an ANDA.
Cadila Healthcare’s revenue grew 27 per cent in FY18 led by a 64 per cent surge (in constant currency) in the US business. The domestic business, in turn, grew around 3 per cent year on year impacted by goods and service tax-related disruptions.
The Edelweiss report pointed out that excluding India and the US, its business grew 2 per cent as growth in Latin American market, wellness and animal health was largely offset by decline in Europe and the active pharmaceutical ingredients segment.