Gilead Sciences, Inc. (Nasdaq:GILD) today announced receipt of a Paragraph IV Certification Notice Letter advising that Lupin Limited submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Ranexa® (ranolazine extended-release tablets).
In the Notice Letter, Lupin alleges that all 10 patents associated with Ranexa are invalid, unenforceable and/or will not be infringed by Lupin's manufacture, use or sale of the product described in its ANDA submission.
Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Lupin. Such a lawsuit would restrict the FDA from approving Lupin's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Ranexa is currently protected by 10 patents, which are listed in the FDA's Approved Drugs Products List and all 10 patents would need to be invalidated or expired before a generic version of Ranexa could be marketed.
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