Generic Lovenox takes step closer to reality, analyst says

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Sandoz, the generics division of Novartis, is soliciting pre-orders for Sanofi-Aventis blood thinner Lovenox—actions that seem to suggest generic approval of the megablockbuster may be coming soon, one analyst says.

Sandoz has been “setting prices and soliciting pre-orders from US purchasers” for its generic version of Lovenox, Sanford Benstein analyst Tim Anderson wrote in an investor note this morning.

Lovenox posted $3.0 billion in US sales in the 12 months ending Nov. 30, according to wholesale sales data from Wolters Kluwer Pharma Solutions. Several companies have applied to launch copy-cat versions, but so far the FDA has withheld approval. One of these, biotech firm Momenta, has a partnership with Sandoz to bring a generic version to market.

“We believe that 2010 may well be the year [a generic could arrive],” a Momenta spokesperson told MM&M, adding, “We have told our investors that we are awaiting approval at this point and believe it could be imminent, although we cannot assure that of course.”

Previous predictions regarding the approval of generic Lovenox have been off base, and this one could prove overly optimistic, as well. According to Anderson, Sandoz's actions represent the first evidence that Novartis is taking action with payers and thus provide reason to believe.

Sandoz's “covert action suggests Novartis believes approval of its generic might finally be nearing,” he advised investors. Moreover, “Sandoz is no newcomer to the generics market. They are one of the top generic companies in terms of size and scope, implying their actions should be taken seriously."
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