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Ranbaxy Consent Decree Includes Unusual Provisions On Exclusivity Relinquishment

Executive Summary

The company’s consent decree with FDA contains unusual language governing the relinquishment of marketing exclusivity for up to eight pending ANDAs. Since the products have not been publicly identified, it is unclear whether the provisions are punitive in nature, reflect technical defects with the applications or merely clarify a 2003 statutory requirement governing forfeiture.

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