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Sun Pharma has received USFDA nod to market Pantoprazole tablets. Pantoprazole is an anti-ulcer drug, with a US market of over USD1 billion. This drug is the generic version of Wyeth's Protonix.
Uday Baldota, VP Investor Relations, Sun Pharma, said he is still not decided whether to launch Pantoprazole at risk. The patent for the drug expires in March 2010. The company has got a 180-day marketing exclusivity with Teva in March 2010, he added.
Excerpts from CMBC-TV18’s exclusive interview with Uday Baldota:
Q: What does this ruling mean, would you now go ahead and launch the product at risk?
A: We have received an approval from the USFDA to market the generic Pantaprozole. We have not yet decided what our options are going forward. So, we have not yet concluded on whether we will launch the product at risk or not. We are still studying the entire case in detail and once we have decided we will make the appropriate announcement.
Q: It is only in 2010 that there is any prospect of shared exclusivity on this drug?
A: The patent expires in 2010. The USFDA has granted us marketing approval. Anyone who is the first filer, with a Para IV certification in the US, gets a 180 days marketing exclusivity. We were one of the first filers and hence we get 180 days marketing exclusivity on this drug.
Q: What about Teva?
A: We share it with Teva.
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Today's Special Column
with Pronab Sen
Union Ministry of Statistics and Programme Implementation , Chief Statistician and Secretary
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