ARTICLE | Clinical News

Remodulin treprostinil regulatory update

March 17, 2014 7:00 AM UTC

FDA denied an October 2013 Citizen's Petition from United Therapeutics asking the agency to not approve any ANDA for a generic version of Remodulin treprostinil that includes proposed labeling that omits or carves out the information in the drug's approved label about IV administration with a high pH glycine diluent. United Therapeutics maintained that omitting the information would be less safe than Remodulin to treat pulmonary arterial hypertension (PAH). The Sandoz generic unit of Novartis AG (NYSE:NVS; SIX:NOVN, Basel, Switzerland) has indicated it will seek such a carve-out from the labeling of its proposed generic. FDA said an ANDA applicant can omit an indication or other aspect of the reference listed drug's labeling that is protected by a listed patent if the omission does not render the proposed generic less safe or effective than the reference listed drug for the conditions of use that remain in the labeling. The agency found that a generic product, when labeled to exclude the information regarding the high pH glycine diluent, will not be less safe or effective than Remodulin to treat PAH.

In March 2012, United Therapeutics filed suit in the U.S. District Court for the District of New Jersey alleging Sandoz's ANDA infringes United Therapeutics patents, U.S. Patent Nos. 5,153,222, 6,765,117 and 7,999,007. The '222, '117 and '007 patents are set to expire in 2014, 2017 and 2029, respectively. However, United Therapeutics said Sandoz stated that it intends to market its generic before the expiration of the patents. FDA is automatically precluded from approving the ANDA for up to 30 months from February 2012 - when United Therapeutics received a Paragraph IV notification letter from Sandoz - or until the court issues a decision that is adverse to United Therapeutics, whichever occurs first (see BioCentury, March 26, 2012). ...