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# Orphan Status for Gilead’s Antiviral Remdesivir
- URL: https://www.fdaweb.com/orphan-status-for-gileads-antiviral-remdesivir/
- Published: 2020-03-24T12:00:00.000Z
- Updated: 2026-09-14T16:08:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146405

FDA approved 3/23 orphan drug status for Gilead’s antiviral drug remdesivir, giving the company seven years of exclusivity for the product, which is one of many being tested as a possible Covid-19 treatment. *The Intercept* [reports](https://theintercept.com/2020/03/23/gilead-sciences-coronavirus-treatment-orphan-drug-status/?ref=fdaweb.com) that experts say the [designation](ttps://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=739020) could block supplies of the drug from generic manufacturers and provide a lucrative windfall for Gilead. It notes that White House domestic policy director **Josh Grogan**, a member of the Coronavirus Task Force, lobbied for Gilead from 2011 to 2017 on issues including drug pricing.

While the orphan drug designation is for drugs that treat illnesses affecting fewer than 200,000 people in the U.S., there is a provision that allows the designation for drugs that treat more common illnesses if the designation comes before the disease reaches that threshold. On 3/24 there were just over 50,000 cases reported in the U.S., although experts say the actual number is likely to be much higher because so little Covid-19 testing has been done.

Gilead announced 3/23 it would no longer provide emergency access to remdesivir, reportedly telling the *New York Times* that “overwhelming demand” left it unable to process compassionate use requests. Hours later FDA announced its approval of the orphan drug status.