Under an exclusive deal with Roche, French drugmaker Sanofi has secured non-prescription rights to the Swiss pharmaceutical giant’s now off-patent influenza drug Tamiflu in the US market.

Before the drug can be sold without a prescription, the US Food and Drug Administration (FDA) would have to approve the switch – a move that pharma market watchers say is not self-explanatory, even though all currently available OTC flu products only alleviate symptoms, while Tamiflu addresses with the virus itself.

In the process, the FDA would also have to review the application based on safety and efficacy established for the original approval but it might also require new clinical studies. Sanofi also would have to rewrite packaging information.

The French drugmaker said it has already begun talks with the FDA and announced that it plans to handle all future US marketing. The company would also have first rights to Tamiflu in the OTC markets of other countries.

“A successful switch of Tamiflu to OTC would support our global cough and cold strategy by expanding into flu with a sustainable point of difference in the market,” said Alan Main, Sanofi’s executive vice president of consumer healthcare. The company’s Mucosolvan OTC cough brand is currently only sold in the EU, Asia and Russia.

Roche has been focusing recently on its newly approved flu drug Xofluza to recoup the generics hit, which led Tamiflu’s sales to fall nearly 30% in 2018. With the Sanofi agreement the Swisss drugmaker could at the same time be creating competition for itself. Xofluza is said to require fewer doses to achieve the same result.

According to the US trade journal Fierce Pharma, Sanofi should have the knowhow to pull off the switch of a drug to OTC, having successfully gained the FDA’s permission in in 2011 to sell its blockbuster allergy treatment Allegra over the counter. After that, it won FDA permission to sell allergy treatments Nasacort and Xyzal as OTC products. Finally, in a 2014 deal with Eli Lilly, it gained OTC rights to the erectile dysfunction blockbuster Cialis.