>Someone needs to let this sorry excuse for an analyst know that the H-W 180-day exclusivity period for generic Lovenox expired in Mar 2009.<
I did! :-)
Thank you for the correction on the Momenta/Sandoz Lovenox 180-day exclusivity. We published a correction which I have included below. Please feel free to contact me if you have any further questions or comments.
Regards,
Michael Waterhouse
Our July 26, 2010 Teva TEVA analyst note contains an error as to 180-day exclusivity of generic Lovenox. According to the Federal Drug Administration's approval letter to Sandoz (a unit of Novartis NVS), 180-day exclusivity will not be granted for the Momenta/Sandoz MNTA marketing of generic Lovenox. Our note incorrectly states Momenta/Sandoz received 180-day exclusivity. However, we stand behind our assertion that Momenta will benefit from its current status as the only generic, and stands to gain higher profits until another competitor can obtain similar FDA generic approval. We expect the Momenta/Sandoz generic Lovenox profit share percentage to approach 50% as outlined in the company's most recent 10-K filing, as opposed to high-single-digit, low-double-digit royalty payments from Sandoz to Momenta once a competitive generic Lovenox is launched, excluding any milestone payments. While it is not clear when Teva might enter the generic Lovenox market, we continue to think that Teva is one of the few companies capable of manufacturing this therapeutic agent, and should eventually receive regulatory approval on its candidate.
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