Para IV products mean, “the first company which submits a completed ANDA (Abbreviated New Drug Application) getting marketing exclusivity for 180 days.”
Natco Pharma has in the pipeline a 20 key `Para IV’ products of which some are expected to be launched in due course.
According to the US Food and Drug Administration (USFDA) norms, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand name upon which the generic is based.
Para IV products
Normally, the first company which submits an Abbreviated New Drug Application (ANDA) with the FDA has the exclusive right to market the generic drug for 180 days. These are called Para IV drug product applications. If successfully launched, these products can earn significant revenue for drugmakers.
Hyderabad-based Natco has Para IV products such as Nexavar (brand) molecule Sorafenib (Cancer/Kidney & Liver), Revlimid(brand) molecule Lenalidomide (Cancer/Multiple Myeloma), Ibruvica (brand) molecule Ibrutinib (Cancer/Leukaemia), Sovaldi (brand) molecule Sofosbuvir (Anti‐Viral / Hep C), Tarceva (brand) molecule Erlotinib (Cancer/NSCLC & Pancreatic) and Aubagio brand molecule Teriflunomide (CNS/Multiple Sclerosis), as per information given for investors. “In the US market, the focus will be on the complex generics,’’ the company said. A majority of the products are in the oncology segment.
Natco has also been focusing on domestic oncology segment and now enjoys market leadership in sales of branded oncology medicines in India. The oncology product range has widened from 6 in 2003 to 29 by the end of the last financial year. The revenue from this segment had risen from ₹ 252.6 crore in FY16 to ₹396.8 crore in FY 19 showing a compounded annual growth rate of 16 per cent over the last four years.
The expenditure on research and development has been increasing steadily from 6.8 per cent in FY16 to 9.3 per cent in FY19. It posted a revenue of ₹2,224 crore in the year ended March 2019. It has 442 scientists and over 40 R&D laboratories in two research facilities.
In the first quarter ended June 2019, Natco’s net profit decreased 21 per cent at ₹143 crore while total revenue too declined 10.65 per cent at ₹513 crore compared to the year-ago period.