> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Appeals Court Affirms Gilenya Patent Blocking ANDAs
- URL: https://www.fdaweb.com/appeals-court-affirms-gilenya-patent-blocking-andas/
- Published: 2022-01-06T12:00:00.000Z
- Updated: 2026-09-14T17:27:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150883

The U.S. Federal Circuit Court of Appeals has [upheld](https://fingfx.thomsonreuters.com/gfx/legaldocs/lgvdwjkkrpo/IP%20NOVARTIS%20PATENTS%20opinion.pdf?ref=fdaweb.com) a lower court decision that found valid a Novartis patent covering a dosing regimen for Gilenya (fingolimod), indicated for treating relapsing forms of multiple sclerosis. The court also affirmed a permanent injunction granted against HEC Pharma until the expiration of the patent in 12/2027\. In 2019, HEC Pharma’s and two other generic drug makers’ ANDAs ([see earlier story](https://www.fdaweb.com/fda-approves-3-andas-for-generic-ms-drug/)) were granted final approval by FDA.  

Novartis has acknowledged that it entered into settlement agreements with a number of ANDA filers that prevent a generic Gilenya launch before an agreed upon and undisclosed date that is prior to the expiration of the dosage regimen patent in 12/2027\. The company has confirmed that it expects no generic versions of Gilenya in the U.S. market for at least the next two years.