Although the first patent for Paxil CR expired in June 2007, generic Paxil CR is still not available -- legal disputes have kept an FDA-approved generic version of the drug from being sold. However, the maker of brand-name Paxil CR has agreed to let Mylan Pharmaceuticals make a generic Paxil CR no later than October 1, 2008.
Paxil CR is manufactured by GlaxoSmithKline. Even though the first patent for Paxil CR has expired, generic Paxil CR is not currently available.
When Will Generic Paxil CR Be Available?
This is a tricky question.
The first patent for Paxil CR expired in June 2007. However, there are still many other Paxil CR patents that have not expired. One generic manufacturer, Mylan Pharmaceuticals, was the first to challenge these Paxil CR patents. Under current laws, the first company to challenge a drug patent will receive 180 days to market their generic exclusively (without any competition from other generic drugs). This 180-day exclusivity period does not start until the first company (in this case Mylan) starts to sell their generic.
Mylan's version of generic Paxil CR was approved by the FDA, but Mylan and GlaxoSmithKline were still stuck in a legal battle concerning the patents. In October 2007, Mylan and GlaxoSmithKline struck a deal; Mylan agreed to stop pursuing the issue, and GlaxoSmithKline agreed to let Mylan make a generic Paxil CR no later than October 1, 2008. Here's where it gets tricky: since no other company is allowed to market generic Paxil CR until at least 180 days after Mylan first starts selling its version, no other companies can make generic Paxil CR yet, even though the first patent has already expired.
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