Natco Pharma Ltd.

Natco Pharma’s marketing partner in the USA, Breckenridge Pharmaceutical, Inc. (BPI), has filed an Abbreviated New Drug Application (ANDA) for Everolimus 0.25mg, 0.5mg, and 0.75mg Tablets.

Both the entities’ Paragraph IV ANDA was filed on the First-to-File date and expected to be the only generic that is entitled to the 180-day exclusivity period.

Novartis AG sells Everolimus 0.25mg, 0.5mg, and 0.75mg Tablets under Brand name Zortress in the USA market. Zortress is used to prevent organ rejection after a kidney or liver transplant. Zortress generated sales of $43.5 million for the twelve-month period ending July 2014, based on industry sales data.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.