Relating to generic version of GSK's migraine drug
Pharma industryobservers are viewing the current settlement of Dr Reddy's with GSK as part of the recent trend among the pharma majors to launch authorised generics before their products lose patent protection.
Hyderabad, Oct. 10
Dr Reddy's Laboratories Ltd has settled the long-pending patent litigation with GlaxoSmithKline relating to sumatriptan succinate tablets, the generic version of GSK's Imitrex tablets, which is the most prescribed migraine medicine in the US.
Announcing the settlement in a press release here on Tuesday, Dr Reddy's said the terms of the settlement remain subject to Government review.
The settlement enables Dr Reddy's to exclusively distribute an authorised generic version of sumatriptan succinate tablets (in the 25 mg, 50 mg and 100 mg strengths) in the US market.
During December 2003, Dr Reddy's had filed abbreviated new drug application (ANDA) for the drug, challenging the patents of the innovator in the US.
Pharma industry observers are viewing the current settlement of Dr Reddy's with GSK as part of the recent trend among the pharma majors to launch authorised generics before their products lose patent protection. Imitrex is one of the big sellers among the GSK's portfolio that is set to lose patent protection.
According to Dr Reddy's, the expected launch date of sumatriptan succinate in the US market would be late in the fourth quarter of calendar year 2008, ahead of the expiration of the paediatric exclusivity on 5037845 patent on February 6, 2009.
However, Dr Reddy's did not disclose additional terms of the settlement agreement entered into with GSK.
GSK's Imitrex tablets had US sales of $890 million for the 12 months period ended June 2006 according to IMS, the release said.
Dr Reddy's scrip marginally gained by 0.81 per cent on the National Stock Exchange on Tuesday to close at Rs 712.80 with 6.44 lakh shares changing hands.
The scrip recorded a year's highest price of Rs 877 and lowest of Rs 390.53 on the bourse.