Natco Pharma submits ANDA to FDA for generic version of Tamiflu 75 mg capsules

Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Natco Pharma 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 Tamiflu^® (oseltamivir phosphate) 75 mg capsules.

In the Notice Letter, Natco alleges that a patent associated with Tamiflu - U.S. Patent Number 5,763,483 - owned by Gilead Sciences is invalid, unenforceable and/or will not be infringed by Natco'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 Natco. Such a lawsuit would restrict the FDA from approving Tamiflu's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Tamiflu is protected by this patent, which is listed in the FDA's Approved Drug Products List, and the patent would need to be invalidated or not infringed upon before a generic version of Tamiflu could be marketed without liability for patent infringement.

Tamiflu was invented by Gilead Sciences and licensed to F. Hoffmann-La Roche Ltd in 1996.