Today Economic times reported that Ranbaxy received conditional approval for combination of its NCE molecule (Arterolane) and piperaquine phosphate.
Drug Controller General of India ( DCGI) Surinder Singh said the marketing licence was subject to the condition that the Chinese plant from where Ranbaxy imported key ingredients for the drug was inspected and approved. Though the final phase of its clinical trial used the same ingredients from China and has been cleared for both safety and efficacy, the government wants to play it safe. “Since it (the drug) will be widely used we want to check for our satisfaction,” Singh said.
Arterolane maleate is patent protected in India. Arterolane is licensed from Medicines for Malaria venture (MMV) and Ranbaxy will have worldwide rights for the registration and commercialisation of the product. Arterolane falls in the chemical class of Synthetic Peroxide Anti-Malarial Drug.
Arterolane seems to be protected by 245779 (1514/DEL/2004) titled “Spiro and Dispiro 1, 2, 4-Trioxolane Antimalarials” granted recently on 02/02/2011. The ‘779 patent is presently assigned to Allergan.