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

Quick Facts

Editors Pick
IKEA is voluntarily recalling 29 million chests and dressers in the U.S. following reports of several injuries, including deaths of three children caused by them tipping over. The recalled chests and dressers are unstable if they are not properly anchored to the wall, posing a serious tip-over and... Dow Chemical Co. (DOW) Tuesday announced its plans to eliminate about 2,500 jobs, or about 4 percent of global workforce, as the company takes full control of Dow Corning Corp., the joint venture formed in 1943 with Corning Inc. Dow Chemicals now owns Dow Corning Corp. completely after Corning exchanged... Quote-to-Cash software provider Apttus is planning Initial Public Offering in the first half of 2017, reported MarketWach.
comments powered by Disqus
Follow RTT