Dr. Reddy's loses exclusivity

By Our Special Correspondent

HYDERABAD, NOV. 17. Dr. Reddy's Laboratories announced that it received notification on November 16 from the U.S. Food and Drug Administration (USFDA) that it is not eligible for the 180-day marketing exclusivity for Omeprazole 40 mg capsules.

A press release issued here on Saturday evening said USFDA also advised Dr. Reddy's that Andrx Pharmaceuticals has now been determined to be the first applicant with a Paragraph IV certification against all other listed patents for Omeprazole 40 mg capsules.

The USFDA advised Dr. Reddy 's that it lost eligibility for exclusivity due to expiration of patent and its six month paediatric exclusivity prior to occurrence of either the 1st commercial marketing of the drug or a decision of court holding the patent which is subject of certification to be invalid or not infringed.The company said that while this was a disappointment, it will however continue its strategy of filing patent challenge product applications for development of its generics business.

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Section  : Business
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