Tuesday 22 January, 2008

Ranbaxy and Dr Reddy settled patent disputes with innovators

Ranbaxy Laboratories Ltd and Dr Reddy’s Laboratories Ltd, India’s top two drug makers, will launch versions of a migraine drug grossing $985 million, or Rs3,891 crore, for GlaxoSmithKline towards the expiry of the patent on the medication, potentially earning profits of up to Rs540 crore more in 2009.
Ranbaxy on Monday said it had settled a lawsuit with the British patent holder GSK, and will enjoy a six-month market monopoly in the US, beginning December. Dr Reddy’s had said in October 2006 that it had been signed on by GSK as the authorized generics partner on Imitrex (sumatriptan succinate), the migraine drug whose patent expires in February 2009.
The Gurgaon drug maker could earn between $80 million and $90 million in the six month exclusivity period, while Dr Reddy’s could earn anything from $22-46 million. Analyst believe that Ranbaxy will earn more profit in comparison to DRL.
It was not immediately clear if Monday’s settlement by Ranbaxy was exclusive or it would share the period with a US unit of Cobalt Pharmaceuticals Inc., an Ottawa-headed firm with which GSK had settled a similar case in November 2006. A Ranbaxy spokesperson insisted the firm would enjoy a full exclusivity period for sumatriptan succinate (the chemical name of Imitrex) for 25mg, 50mg and 100mg strengths.
Monday’s development is similar to a market situation involving the two drug makers and Merck and Co. Ranbaxy, as the patent challenger on Merck cholesterol drug Zocor, had earned revenues of $60 million and Dr Reddy’s, as Merck’s partner for Zocor and prostrate cancer drug Proscar, had grossed $400 million in sales.
In an unrelated development, Dr Reddy’s on Monday said it had settled with Novartis AG not to introduce generic variants of Alzheimer’s drug Exelon that grossed the Swiss drug maker $199 million in 2006. Terms of the settlement were not disclosed.
ExelonÒ (rivastigmine tartrate) is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate.Exelon Capsules contain rivastigmine tartrate, equivalent to 1.5, 3, 4.5 and 6 mg of rivastigmine base for oral administration. Inactive ingredients are hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, and silicon dioxide. Each hard-gelatin capsule contains gelatin, titanium dioxide and red and/or yellow iron oxides.

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