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Depomed Receives Notice of Paragraph IV Certification Against Patents for Gralise

Depomed, Inc. (Nasdaq: DEPO) today announced that it has received a Paragraph IV certification notice from Actavis Elizabeth LLC advising Depomed that Actavis has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Gralise ^ (gabapentin), 300 mg and 600 mg tablets. Actavis' certification notice alleges that Depomed's six US patents for Gralise listed in the FDA Orange Book, the latest of which expires in 2024, will not be infringed by Actavis' proposed product, or are invalid and/or are unenforceable.

Posted-In: News FDA

 

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