FDA Approves First Generic Version of Tamiflu

August 9, 2016
Caroline Hroncich
Pharmaceutical Executive

August 09, 2016

FDA gave the okay to a generic version of Roche’s blockbuster Tamiflu (oseltamivir phosphate), the first generic version of the drug approved in the United States, FDA said in an August 3, 2016 statement. Tamiflu was developed by Gilead Sciences and licensed to Roche in 1996. The drug was later approved by FDA in 1999.

This generic version of Tamiflu is co-marketed by Natco, an Indian pharmaceutical company, and US-based Alvogen. In December 2015, Natco and Alvogen settled a patent infringement with Gilead Sciences, Genentech, and Roche, allowing them to market the capsules before the February 23, 2017 expiration of Tamiflu’s pediatric exclusivity period, Natco said in a press release.

But Natco and Alvogen’s generic did not have a swift path to market. In 2011, Gilead sued Natco alleging that it’s Abbreviated New Drug Application (ANDA) infringed upon the company’s patent. A district court ruled in favor of Gilead, and Natco later appealed to a federal court. The appeals court overturned the decision, siding with Natco saying, “…the court contends that Gilead acted improperly by continuing to pursue claims in the application that issued as the ’375 patent. To support this conclusion, the court holds that in the case of competing patents, a patentee is stuck with the earliest expiration date irrespective of filing or issue dates.” Gilead later appealed the decision to the US Supreme Court but the petition was denied.

Tamiflu raked in 410 million Swiss Francs (approximately $421.09 million) in the first half of 2016, Roche said in a half year earnings report. According to the report, Tamiflu sales declined 18% due to a weak influenza season, but it is still the company’s top selling infectious disease product. According to FDA, Tamiflu is used to treat influenza A and B in patients two weeks of age and older who have had flu symptoms for no more than 48 hours. The drug can also be used to prevent flu in children one year of age and older.

Source: FDA, Natco