Tamiflu (oseltamivir phosphate) was originally developed by Gilead Science, and licensed to Roche in 1996. It is an anti-viral drug used to treat (and prevent) influenza, and can be taken as a pill or liquid. It works by blocking the action of enzymes in the flu virus that are required for it to reproduce, and therefore spread. Although the drug has come under criticism, it remains recommended for use by many medical organizations and can be found on the World Health Organization’s List of Essential Medicines.

Indian pharmaceutical company Natco, who recently had a generic for sleep disorders approved by the US Food and Drug Administration (FDA) [1], first challenged the Tamiflu patent back in 2011 [2], although it took several years for a settlement to be reached. Natco set out to develop their own 30 mg, 50 mg and 75 mg capsules of the drug, the application for which was finally approved by US Food and Drug Administration in August 2016. The generic drug was launched just a few months later, in December 2016.

The drug has been launched with Natco’s marketing partner Alvogen, a growing pharmaceuticals company with offices in 35 countries and 60 pending abbreviated new drug applications (ANDAs). The introduction of generic oseltamivir follows their 2015 launch of the first generic version of Novartis’ Alzheimer’s treatment Exelon (rivastigmine transdermal system) in the US [3].

Tamiflu had sales of over US$400 million for the year ending December 2015, and Alvogen says its generic version could save the US healthcare system over US$500 million in this flu season alone. Chairman and CEO of Alvogen, Robert Wessman said the launch would be of great benefit for patients in the US as it will provide them with access to an affordable alternative to the flu medication. The approval also represents important progress for Alvogen’s business in the US generics market.

Several pharmaceutical companies have also developed generic versions of Tamiflu – although they have never been launched in the US. In 2006 for example, Roche granted Hetero Drugs a sublicence to manufacture the drug. In India, after the government permitted ‘restricted’ sales of the drug [4], the market saw a boost of activity, including from Cipla, which marketed oseltamivir as Antiflu in both capsule and syrup form.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Lupin and Natco’s Armodafinil generic approved to treat sleep disorders by FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from: www.gabionline.net/Generics/News/Lupin-and-Natco-s-Armodafinil-generic-approved-to-treat-sleep-disorders-by-FDA
2. GaBI Online - Generics and Biosimilars Initiative. Generics to cash in on swine flu epidemic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from: www.gabionline.net/Generics/News/Generics-to-cash-in-on-swine-flu-epidemic
3. GaBI Online - Generics and Biosimilars Initiative. First generic version of Alzheimer’s patch launched in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from: www.gabionline.net/Generics/News/First-generic-version-of-Alzheimer-s-patch-launched-in-US
4. GaBI Online - Generics and Biosimilars Initiative. Indian firms race to sell generic oseltamivir [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 20]. Available from: www.gabionline.net/Policies-Legislation/Indian-firms-race-to-sell-generic-oseltamivir

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