LOGO
LOGO

Quick Facts

United Therapeutics Files Suit Blocking Sandoz ANDA For Generic Remodulin

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Global Economics Weekly Update - Jun 01 - Jun 05, 2026

June 05, 2026 16:18 ET
A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.

Latest Updates on COVID-19