logo
Share SHARE
FONT-SIZE Plus   Neg

United Therapeutics Files Suit Blocking Sandoz ANDA For Generic Remodulin

United Therapeutics Corp. (UTHR) Thursday reported filing a lawsuit against Sandoz Inc. which seeks to block the approval of an Abbreviated New Drug Application, or ANDA, for the marketing of a generic version of United Therapeutics's product Remodulin.

Sandoz, a subsidiary of Novartis AG (NVS), claims in its ANDA that three US patents relating to Remodulin are "not valid, not enforceable" and cannot be infringed by production of a generic version.

Further, the US Food and Drug Administration, or FDA, is automatically precluded from approving the ANDA for up to 30 months as a result of the filing, which occurred within 45 days of Sandoz filing its application.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Shares of WM Morrison Supermarkets Plc were gaining more than 4 percent in the early Thursday morning trading as it reported 0.7 percent increase in first-quarter like-for-like sales excluding fuel. LFL sales were up 1.2 percent, including fuel. Zynga Inc. (ZNGA) on Thursday reported a first-quarter loss that narrowed from a year ago, reflecting an increase in revenues despite continued drop in user-base. Earnings for the quarter trumped analysts estimates, as did revenues, sending the company's shares up 13 percent in extended trading hours. San... Shares of Fitbit Inc. (FIT) slumped over 12 percent in extended hours trading after the maker of wearable technology reported a drop in first-quarter profit hurt largely by a surge in operating costs. The company also detailed a weak outlook for the second quarter. Fitbit's profit for the first-quarter...
comments powered by Disqus
Follow RTT