Dr Reddy’s launches nateglinide generic for diabetes in US

Dr Reddy’s is the first to launch nateglinide generic, but likely to share exclusivity with Teva, Par.

Dr Reddy’s Laboratories Ltd has launched a nateglinide generic to treat type 2 diabetes in US

Dr Reddy’s nateglinide is a generic version of Novartis’ diabetes Starlix.

Dr Reddy’s, which received US FDA approval last week for its generic nateglinide, is one of four to have entered the world’s biggest pharmaceuticals market US with the generic version of Starlix.

Dr Reddy’s is the first to launch nateglinide generic in US market. However, Dr Reddy’s failed to get the 180-day exclusivity for nateglinide as the company failed to get approval for the drug within  the stipulated 30 months after its Para IV filing.

New York-based Par Pharmaceutical, Israel’s Teva and California, US-based Watson Pharmaceuticals are othe generic companies planning to launch nateglinide in US.

Watson’s generic nateglinide is expected to get approval shortly, Dr Reddy’s was the first to launch the product.

Dr Reddy’s was likely to share 180-day exclusivity to sell nateglinide in the United States along with other generic players, including Teva Pharmaceutical Industries and Par Pharmaceutical.

The $2.8 billion Dr Reddy’s is reportedly planning to launch six to seven new generics in the United States in 2009/10, including blockbuster omeprazole.

Omeprazole is a generic version of AstraZeneca’s  Prilosec (omeprezole). It is indicated for the treatment of stomach ulcers and acid reflux.

If successful, Dr Reddy’s will be the second generics maker after Perrigo to sell the generic version of  of omeprezole in US.

Dr Reddy’s had launched acute migraine drug sumatriptan in US last year. Sumatriptan is a generic version of GlaxoSmithKline’s Imitrex, in the U.S. market.

Recently, it has been reported that world’s leading drug makers including GlaxoSmithKline and Merck are reportedly in race to buy 23% stake in India’s 2nd largest generic firm Dr Reddy’s.

Dr Reddy’s, however, denied the media reports saying that the promoters of the company have no intention to dilute or sell their stake, at the moment.

Dr Reddy’s shares rose as much as 7.5 percent on Thursday to its highest in more than three years, in Bombay Stock Exchange last week triggering speculations that certain MNC is planning to pick up 23%  founder’s stake in the Hyderabad based company.

In June, DRL had agreed to supply GSK with over 100 branded drugs to be sold in Africa, west Asia, Asia Pacific and Latin America.

The products will be manufactured by Dr. Reddy’s and will be licensed and supplied to GSK in various emerging markets  excluding India. Revenues will be reported by GSK and will be shared with Dr. Reddy’s as per agreed terms. In certain markets products will be co-marketed by Dr. Reddy’s and GSK.

Established in 1984, Dr. Reddy’s Laboratories is an emerging global pharmaceutical company. Dr Reddy’s has three core businesses: Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products. Our products are marketed globally, with a focus on India, US, UK, Germany and Russia.

Dr Reddy’s has been in financial troubles due to supply constraints for its German Subsidiary, Betapharm for quite some time.

Dr Reddy’s Laboratories  posted a 3.76 per cent drop in net profit at Rs 156.1 crore for the fourth quarter ended March 31, 2009, as compared to Rs 162.2 crore in the corresponding period a year ago.Dr Reddy’s gross earnings rose by 12.36 per cent to Rs 1,166.5 crore for the quarter under review as against Rs 1,038.1 crore.

As per the audited consolidated results, the group has posted a net loss attributable to the shareholders of the parent of Rs 917.2 crore for the year ended March 31, 2009 as compared to a net profit of Rs 438.1 crore for the previous corresponding year.

Dr Reddy’s has written down $290 million against its German unit Betapharm resulting in a March quarter loss.

Dr Reddy’s Laboratories decided to wind up its proprietary products development to Aurigene -a wholly-owned arm, as part of a major restructuring operation to offset the fourth quarter losses incurred following the write-down of $290 million against the German unit Betapharm. Dr Reddy’s also decided to close down research facility in Atlanta in the United States.