Dr Reddy's Laboratories, having lost its eligibility for a 180-day marketing exclusivity for Omeprazole 40 mg capsules in the US generics market, is, nevertheless, hoping to become a sizable player in all the dosage forms of Omeprazole after the exclusivity period is over.
Responding to queries in a conference call discussion on Omeprazole today, G V Prasad, the chief executive officer of the company, said that it is a complex product to formulate and, hence, hoped that the price erosion in the post-exclusivity period may not be substantial.
As of now, he said, there are only 4 to 5 players who have tentative approvals for the product from US FDA. Branded as Prilosec by the patent holder AstraZeneca, Omeprazole has an annual market size of about $4 billion.
Also Read
On the possibility of appealing to FDA about the marketing exclusivity, Prasad said that it can not be confirmed at this juncture though the company's lawyers are examining the issue.
Prasad disclosed that the company is working on six products right now and some of them could have first-to-file status. He also confirmed that, without giving the details of the product, the company has filed a para IV filing on November 19, which they believe are first-to-file.
Dr Reddy's has already claimed that it has the first-to- file status, which on successful establishment provides 180-day marketing exclusivity, for Ciprofloxacin 100 mg tablets, Olanzapine 20 mg tablets and Ondansetron 4 mg, 8 mg and 24 mg tablets. However, none of these products can be launched before the end of 2003 in the US generics market due to patent validity.