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news.Gilead Sciences has received Paragraph IV Certification Notice Letter advising that Natco Pharma had submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) related to generic version of Tamiflu.
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Tamiflu was invented by Gilead Sciences and licensed to F Hoffmann-La Roche in 1996.
In the notice letter, Natco requested permission to manufacture and market a generic version of Tamiflu (oseltamivir phosphate) 75 mg capsules.
Natco alleges that a patent associated with Tamiflu – US 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 has 45 days from the date of receipt to commence a patent infringement lawsuit against Natco.