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# Pernix Seeks to Block Zohydro ER Generics with Patent
- URL: https://www.fdaweb.com/pernix-seeks-to-block-zohydro-er-generics-with-patent/
- Published: 2016-03-09T12:00:00.000Z
- Updated: 2026-09-15T02:42:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135010

> Pernix Therapeutics is asking FDA to refuse to approve any ANDA or relevant 505(b)(2) NDA citing Pernix’ Zohydro ER (hydrocodone bitartrate) extended-release capsules as the reference-listed drug if the applicant proposes to omit from the labeling certain safety-related information that is protected by patent. In a 2/25 [petition](http://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-0713-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com), Pernix says that the Zohydro ER labeling includes information about administering the drug to patients with mild or moderate hepatic impairment. It says the “critically important safety information” is protected by a patent and information that the company submitted for listing in the *Orange Book*.  
>  
> The company says that the patent-protected labeling information cannot be omitted from a generic drug label because such omission “would render the … drug product deficient in important safety information, deprive physicians and patients of critical information regarding the safe administration of the drug product, and put patients at risk.”