Washington, May 2 (Bloomberg) AstraZeneca, Europe's second-largest drugmaker, said the US Food and ...
Washington, May 2 (Bloomberg) AstraZeneca, Europe's second-largest drugmaker, said the US Food and Drug Administration has extended the patent for Prilosec, the world's best-selling drug, for six months.
AstraZeneca shares rose 21p, or 0.7%, to 3,266p in late trading.
The FDA approved the use of the ulcer treatment in children, the company said in a statement released on the UK's Regulatory News Service.
The company would not say when the extension will begin or expire, although analysts expect it will last through October.
The extension, which was expected, will keep lower cost generic competitors off the market and give AstraZeneca more time to switch patients to Nexium, the ulcer drug it's tapped as a replacement.
Generic drugs are chemically identical to branded drugs and can only be made after patent protection for the brands expires. Because their makers spend less on research and marketing, generic drugs sell for less than half the price of brand-name equivalents. Prilosec had sales of about $6bn last year.
AstraZeneca has filed lawsuits against companies looking to make generic versions of Prilosec. A judge in New York will hear a case later this month involving four companies that want to make rival drugs.
In 1999, the FDA requested that AstraZeneca provide information on the clinical efficacy of Prilosec in the pediatric population, as well as pharmacologic and clinical safety information.
Newark, New Jersey, April 19 (Bloomberg) AstraZeneca, maker of Prilosec, sued Ivax over its plans to make a generic version of the best-selling heartburn drug.
The federal lawsuit, filed in Newark, alleges that Ivax's unit, Zenith Goldline Laboratories Pharmaceuticals, infringed six AstraZeneca patents by applying to the US Food and Drug Administration for permission to sell a generic version of Prilosec. London-based AstraZeneca said that Miami-based Ivax is infringing patents that expire between 2005 and 2014. AstraZeneca spokeswoman Rachel Bloom-Baglin said: "For pharmaceutical companies, patents are necessary to ensure that large investments are recovered."
AstraZeneca has filed eight other lawsuits against generic drugmakers since 1998 in similar patent disputes over Prilosec.
Four cases have been consolidated in federal court in Manhattan and are scheduled for trial in May, she said.
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