Raltegravir application still pending in India

18 Dec 2007

Following various enquiries from interested parties about the status of the Raltegravir (Isentress) patent in India, we can confirm that it is still pending.

The key patent claiming the compound Raltegravir is 868/CHENP/2004. Titled ‘N-Substituted Hydroxypyrimidone Carboxamide Inhibitors of HIV Integrase’, the application was published in India on 13 January 2006. Notably, the applicant is Istituto Di Ricerche Di Biologica Molecolare P. Angeletti and not its parent company Merck & Co Inc.

Corresponding patents include US 7217713, US 7169780, EP1441735 (all granted) and WO03035077, which includes ARIPO, OAPI, South Africa and Brazil as designated states.

In addition to these patents, Merck has filed a PCT application for the salt of Raltegravir, titled ‘Potassium Salt of an HIV Integrase Inhibitor’, and published as WO2006/060712. This application designates India, but to date does not appear to have been published.

Like Maraviroc, Raltegravir is positioned to be an important HIV salvage therapy for patients. Raltegravir was given accelerated approval on 12 October 2007 by the FDA.

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