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FDA grants provisional approval for copycat esomeprazole magnesium

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Ranbaxy Laboratories Limited (RLL) yesterday announced that they had received tentative approval from the US Food and Drug Administration for esomeprazole magnesium delayed-release capsules.

The drug, indicated for the short-term treatment of erosive oesophagitis, heartburn and other symptoms associated with gastroesophageal reflux disease (GORD), is manufactured by Anglo-Swedish firm AstraZeneca under the brand name Nexium®.

AstraZeneca filed a lawsuit in 2005, alleging “wilful infringement” of patents protecting Nexium. The company is still embroiled in ligitation with Ranbaxy and other firms, and fears considerable loss in earnings if generic versions of Nexium were available on the market.

Nexium is the second largest-selling drug in the USA, with total annual market sales of $5.5 billion.

Ranbaxy believes that it has a First to File status on the drug, which would provide it with a potential 180 days marketing exclusivity.

Ranbaxy Pharmaceuticals Inc (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of RLL, India’s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.

FDA

Your comments: (Terms and conditions apply)

“I think that it is good news for consumers if the product will be offered at a considerable discount (given the outrageous cost of Nexium) to sufferers.” – Name and contact details supplied



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