Natco Pharma and Alvogen launch first US Tamiflu generic

Genéricos/Novedades | Posted 20/01/2017 post-comment0 Post your comment

Natco Pharma (Natco) and their marketing partner Alvogen have launched the first generic equivalent of Roche’s flu treatment Tamiflu (oseltamivir phosphate) in the US.

Capsules visual V16A24DG

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.

Related articles
Celgene settles Revlimid patent litigation with Natco Pharma

Alvogen opening biosimilars plant in Iceland

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

Source: Alvogen; Natco Pharma

comment icon Comments (0)
Post your comment
Related content
Sandoz launches ferumoxytol and pemetrexed generics
88 MD002468
Genéricos/Novedades Posted 03/09/2021
US generic approvals for Acrux and Cipla
31 MD000575
Genéricos/Novedades Posted 16/07/2021
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010