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
U.S. food maker Kraft Heinz Co., which had offered $143 billion in cash and stock to buy Anglo-Dutch consumer goods company Unilever, Sunday said it has amicably agreed to withdraw its proposal for a combination of the two companies. Dairy giant Saputo Inc. is voluntarily recalling certain Gouda cheese products in the U.S. due to potential listeria contamination. Saputo said one of its suppliers, Deutsch Kase Haus, LLC of Middlebury, Indiana, notified the company that some specialty Gouda cheese products that it supplied to Saputo's Green Bay, Wisconsin facility may have been contaminated with Listeria monocytogenes. Amazon is exploring the possibility of using parachutes to drop drone-delivered packages. The e-commerce giant has been granted a patent titled, "Maneuvering a package following in-flight release from an unmanned aerial vehicle".
comments powered by Disqus
Follow RTT