Natco Pharma files ANDA for Sofosbuvir Tablets with USFDA

01 Mar 2018 Evaluate

Natco Pharma has filed an Abbreviated New Drug Application (ANDA) for Sofosbuvir Tablets, 400mg, with the US Federal Drug Administration (USFDA). Sofosbuvir is a medicine used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc., under its brand Sovaldi.

The company believes that they are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final USFDA approval.

For the 12 months ending December 31, 2017, SOVALDI had US sales of around $130 million as per Gilead Sciences Inc. unaudited results released for the year ending December 31, 2017.

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.

Natco Pharma Share Price

933.60 -15.25 (-1.61%)
05-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1804.95
Dr. Reddys Lab 1275.05
Cipla 1520.55
Zydus Lifesciences 931.45
Lupin 2097.65
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×