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# FDA Asks Court to Deny Orenitram Exclusivity
- URL: https://www.fdaweb.com/fda-asks-court-to-deny-orenitram-exclusivity/
- Published: 2018-01-11T12:00:00.000Z
- Updated: 2026-09-14T23:13:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140471

FDA is asking the DC federal court to dismiss United Therapeutics Corp.’s (UTC) suit seeking seven years of market exclusivity for its Orenitram (oral treprostinil), indicated for treating pulmonary arterial hypertension. FDA rejected the company’s application and UTC appealed that decision to the court.

In its [filing](http://src.bna.com/vmj?ref=fdaweb.com) in response to United Therapeutics’ request for summary judgment, FDA says the company failed to tell the court that Orenitram “is merely the latest in a line of such drugs.” The agency notes that UTC developed two earlier drugs for the same condition, both of which received marketing exclusivity. Remodulin received exclusivity for being the first drug of its kind, it says, and Tyvaso received it for being clinically superior to Remodulin.

“Orenitram is not the first nor is it clinically superior,” FDA asserts. “Yet UTC nevertheless claims that developing the drug entitles it to extend its 14-year monopoly on treprostinal drugs to 21 years…. Contrary to what UTC argues, such a monopoly is not compelled by the Orphan Drug Act, and not justified given the facts of this case.”

The agency says the court should grant it deference for its application of the Orphan Drug Act and deny the UTC request.