FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Federal Judge Upholds UTC's Remodulin Patent Against Sandoz ANDA

Sept. 9, 2014
A A

Sandoz must wait until a patent on United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin expires in 2017 before it can market its generic version.

A federal judge in New Jersey ruled Aug. 29 that Sandoz’s 2011 Paragraph IV ANDA against Remodulin (treprostinil sodium) infringed on its ’117 patent, which remains valid until Oct. 24, 2017.

In a 2012 lawsuit, UTC had sought to block generic approval on Remodulin until its last patent, the ’007, expires in 2029. However, the judge found that Sandoz’s ANDA didn’t infringe the ’007 because the generics maker excluded the patent’s form of administration via a specific kind of sterile diluent.

Sandoz had challenged both patents as obvious for other drugmakers to try, a claim the court rejected. The generics maker initially had challenged three of Remodulin’s patents, but claims in UTC’s infringement lawsuit over the ’222 patent were dismissed in June when Sandoz switched its filing to a Paragraph III ANDA, promising not to produce its own version at least until that patent expires in October of this year.

No other generics makers have won approval for a version of Remodulin, according to the Orange Book. The drug earned UTC $136.1 million in the first quarter of the year, according to financial filings by the company.

Sandoz declined a request to comment, and UTC did not respond by press time. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.