To market a generic version of a previously branded drug, a company must receive approval for an abbreviated new drug application (ANDA) from the FDA. The first company to receive approval for an ANDA is entitled to 180 days of marketing exclusivity for their generic drug, during which time no other generics companies can market their product. The FDA can grant tentative approval to all meritorious ANDAs, even if a company is not the first to file the ANDA and/or is not the company that is entitled to the 180-day market exclusivity. Companies that are not entitled to such exclusivity can only market their product after the 180-day period.
Matrix and Ranbaxy are among the companies that have filed ANDAs for atorvastatin (the FDA keeps the status of pending ANDAs confidential); however, to date no full or tentative ANDAs have been approved by the FDA. Ranbaxy are believed to have filed the first ANDA for atorvastatin — which has been pending for nearly 9 years — so they may be granted the 180-day market exclusivity. But Ranbaxy have had problems with their drug manufacturing processes, and Matrix believed this could affect Ranbaxy's ANDA for atorvastatin; if it was shown that Ranbaxy were not able to manufacture the drug in line with FDA requirements, they would have to withdraw and resubmit the ANDA, and forfeit the 180-day exclusivity.
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