Ranbaxy to get 180-day exclusivity on Pravastatin 80 mg?

According to CNBC-TV18, the US FDA ruling may help Teva get exclusivity for Pravastatin from April 20. Teva is likely to get 180-day exclusivity for 10, 20 & 40 mg in the US. Ranbaxy too may get 180-day exclusivity on Pravastatin 80 mg on the US FDA ruling.

Vikas Dandekar, CNBC-TV18's pharma research analyst speaks on US FDA ruling and its impact on Ranbaxy Laboratories.

Q: US FDA ruling, is it going to impact Teva, Ranbaxy  Laboratories immediately? Is it a final ruling that we are hearing from them?

A: This is a bigger victory for Teva which has three exclusivities pending on 10 , 20 , 40 mg. This is a one million plus dollar product in the US market. Ranbaxy also has 80 mg exclusivity pending and that exclusivity comes into force the day the patent expires which is tomorrow April 20.  Reading from analysts reports we understand that this is definitely something that is likely to happen, a very big win for Teva but definitely a very big upside for Ranbaxy.

Q: How much could Ranbaxy garner and how much would go to Teva?

A: From conservative estimates we learn that it is about  USD 250 – 300 million market for 80 mg. If we look at a 6-month exclusivity, and take 50% price erosion in effect of that 6 month period, it could be about a USD 150 million kind of gain that Ranbaxy may register in its books.

Q: Is that likely to be diluted by any other players stepping into the same space once Ranbaxy and Teva get the approval?

A:  Our understanding is that it is only Ranbaxy which got the exclusivity for 80 mg , the rest 10 ,  20 and 40 are pending approval with Teva.

Q: What are you hearing on the results of Ranbaxy ?

A:  We are hearing from the market analysts that there will be a jump in revenues but the bottomline will not look so good. There will be definitely a good recovery. Going forward we do expect a lot of good launches coming from Ranbaxy. Pravastatin is also one of them. So in the next couple of months there is likely to be a good recovery for Ranbaxy.