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
Media conglomerate Viacom, Inc. on Tuesday reported a 10 percent decline in profit for the first quarter from last year, reflecting lower revenues in the Filmed Entertainment and Media Networks segments. However, adjusted earnings per share for the quarter matched analysts' expectations, while revenues missed their estimates. Google chief Sundar Pichai is poised to become the highest-paid chief executive in the U.S. after parent company Alphabet awarded him $199 million in shares. Alphabet Inc. (GOOGL, GOOG) disclosed in a regulatory filing with the U. S. Securities and Exchange Commission that it awarded 273,328 shares worth $199 million to Pichai on February 3rd. Transmission utility ITC Holdings Corp. announced Tuesday that it has entered into an agreement and plan of merger to be acquired by Canadian electric and gas utility company Fortis Inc. in a deal valued at approximately $11.3 billion. ITC shareholders will receive $22.57 in cash and 0.7520 Fortis shares per ITC share.
comments powered by Disqus
Follow RTT