Dr Reddy's laboratories expects to launch the generic version of Copaxone in the US market during the first half of next fiscal.
Copaxone(glatiramer acetate injection) isa multi-billion dollar drug anda prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis.
"We are on track to respond to FDA on the queries received in Jan/Feb18 over next couple of months. Post that, we are likely to get new (target action date) TAD/Goal Date."
"While it is difficult to speculate the timelines for FDA review, we remain optimistic with respect to the approval / launch of this product sometime in the first half of next year," a Dr Reddy's spokesperson told PTI in an email reply.
Natco Pharma's marketing partner Mylan had already launched generic version of the same drug in the US market in October 2017.
On Suboxone that contains buprenorphine and naloxone, the DRLK official said they have received a minor complete response in January and the drug maker received a new TAD/Goal Date.
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"We believe the file is progressing in the right direction. As far as the launch is concerned, we believe we have a good IP position and will evaluate based on a holistic review of the entire IP landscape," the official said.
Suboxone is used to treat adults who are dependent on (addicted to) opioids (either prescription or illegal).
On birth control deviceNuvaring, the DRL official said they are optimistic of launching the product during the current fiscal.
Earlier, a senior official of the city-based drug maker had said they were eyeing to launch about 16-16 new products in the US market every year.
Dr Reddys' over all Global Generic sales declined by one per cent Rs 11,400 crore in FY 18 primarily on account of lower contribution from North America generics markets due to higher price erosion and unfavorable US dollar conversion.
The only way out is to launch more new products and manage the cost, CEO and Co-Chairman of Dr Reddy's GV Prasad had said during the Q4 results announcement.
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