DRL launches 5 drugs in the US

Dr Reddy’s Laboratories (DRL) on Sunday said the company has launched five generic drugs in the US market during the last month, which together have a potential market value of over $3.78 billion.

The company launched generics or process-changed cheap versions of UCB's Keppra, Prilosec DR (Astra Zeneca), Prilosec CD (GlaxoSmithKline), Abbott’s Depakote and GlaxoSmithKline’s Lamictal, following approval from the US FDA. However, the company lacks exclusive rights to sell any of these drugs and therefore, will have to compete with other generic drug makers having approvals for these products. When a drug goes off-patent in the US, prices often falls over 90 per cent due to generic competition.

This will result in price erosion and margin issues.

Dr Reddy's had posted over 151 per cent jump in its net profits for the third quarter, mainly driven by the exclusive six month launch of an authorised generic version of GlaxoSmithKline’s Imitrex (sumatriptan succinate), in late November 2008.

Dr Reddy's had received approvals for generics of epilepsy drug Keppra (Levetiracetam) tablets in 250mg, 500mg, 750mg and 1000mg category. According to IMS sales figures, it had annual sales of $1.1 billion for the 12 month sales ending September 2008. In October 2007, Dr Reddy's had reached an out of court settlement on the patent infringement case with UCB on Keppra, along with Mylan.

Prilosec delayed release (DR) tablets (omeprazol) of AstraZeneca had an annual sales of $168 million for the 12 month period. The drug is indicated in the treatment of stomach ulcers and acid reflux.

GlaxoSmithKline’s Prilosec CD tablets had recorded an annual sales of $87 million and Abbott’s Depakote Delayed Release capsules had an annual sales of $126 million. The approval for Dr Reddy's are for 5mg and 25mg versions of Prilosec and for 125 mg version of generic Depakote, which is indicated for the treatment of manic episodes associated with bipolar disorders.

Dr Reddy's got approval for 25mg, 100mg, 150mg and 200mg of lamotrigine tablets, the generic version of GlaxoSmithKline’s Lamictal tablets, a drug with annual sales of $2.3 billion. Lamictal is to treat seizures and bipolar disorder. The drug lost patent protection in July last year.