Pharma major Cipla plans to name its hepatitis C drug with Gilead Sciences as Hepcvir, its chairman Yusuf K Hamied on Wednesday. Last year Gilead Sciences has licensed its hepatitis C drug Sovaldi (chemically known as sofosbuvir) to seven India-based drugmakers including Cipla which will sell the cheap generic versions of the drug in 91 developing nations. Hepcvir is the brand name and we are working on it. We will apply probably for regulatory approval in the next couple of months and hopefully by middle of the year we will be in market for India. We have the stocks of the raw materials, we are already started making the raw materials. We have to put the stability data of active pharmaceutical ingredients, stability data of the formulation, we have to do bioequivalence of the originator product, so these takes around six months and this is already in process," he said.
The Mumbai-based drug maker has signed a non-exclusive licensing agreement with Gilead for manufacturing and distribution of Sofosbuvir mono, Ledipasvir mono, the fixed-dose combination of Ledipasvir/Sofosbuvir with each other and the combination of Sofosbuvir or Ledipasvir with other active substances, for the treatment of hepatitis C.
All companies have been allowed to set their own prices for the generic drug and will pay Gilead a royalty on their sales.
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