Biotech Values

[DewDiligence]

(MNTA)—FDA finally approved Teva’s generic Lovenox today, four years after approval of MNTA’s generic and eleven years (!) from Teva’s original ANDA submission:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails

Teva presumably reworked its Lovenox product, following the roadmap to approval the FDA published in 2010 when approving MNTA’s generic Lovenox (#msg-52582225, #msg-52581746). We already know from Court documents that this is how MNTA’s other competitor, Amphastar received approval for generic Lovenox in 2011.

For MNTA, the financial implications of Teva’s approval are negative, of course, but the magnitude is small; Lovenox has been generating only a few million dollars per quarter of royalties from NVS.