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# Vifor Fresenius Wants Velphoro Exclusivity
- URL: https://www.fdaweb.com/vifor-fresenius-wants-velphoro-exclusivity/
- Published: 2016-04-21T12:00:00.000Z
- Updated: 2026-09-14T20:56:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135448

> Vifor Fresenius is asking FDA to grant five-year new active ingredient exclusivity to its Velphoro (sucroferric oxyhydroxide). A 4/15 [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-1163-0001&attachmentNumber=2&disposition=attachment&contentType=pdf&ref=fdaweb.com) also asks the agency to stay the acceptance, receipt, filing, review, and approval of any ANDA or 505(b)(2) application referencing Velphoro while it continues to consider the drug’s exclusivity status.  
>  
> The company notes that FDA has been considering the five-year exclusivity for more than 17 months. “Given the imminent expiration of Velphoro’s three-year exclusivity on 11/27,” the petition says, “Vifor Fresenius will be irreparably harmed if the commissioner fails to act soon. Vifor Fresenius respectfully requests expedited consideration of the stay portion of this petition.”  
>  
> The petition lists these reasons why Velphoro is entitled to five-year new active ingredient exclusivity under either the agency’s active moiety standard or the Federal Food, Drug, and Cosmetic Act’s active ingredient standard:  
> Velphoro is a novel iron-based phosphate binder with a different active moiety from previous iron-based products; FDA has agreed that there are significant physiochemical differences between Velphoro’s iron oxyhydroxide active moiety and the iron oxyhydroxides in previously approved products; Velphoro does not contain a previously approved active ingredient; and Velphoro’s physiochemical differences are essential for the desired therapeutic indication, not minor differences that the agency can ignore.  
>  
> The petition also argues that FDA is not in a position to deal with any ANDA or 505(b)(2) application unless and until it has determined whether such action is lawful by ruling on Velphoro’s five-year exclusivity.