New survey on MNTA-Amphastar pre-launch maneuvering…
Background: When Amphastar received FDA approval to sell a generic version of Lovenox on 9/19/11, Watson Pharmaceuticals, Amphastar’s marketing partner, issued a press release that said Amphastar “anticipates launching the product during the fourth quarter of 2011” (i.e. 10/1/11 – 12/31/11).
Ordinarily, a US generic drug is launched soon after FDA approval, so a delay of anywhere from two weeks to three months deserves discussion and speculation.
Q1: Will MNTA sue Amphastar for patent infringement in the near future?
a) Yes b) No
Q2: If MNTA does sue Amphastar for patent infringement, will the lawsuit succeed in averting Amphastar’s launch through either an injunction or a stipulation by the parties?
a) Yes b) No
Q3: Which of the following scenarios most closely matches your opinion of the rationale for Amphastar’s purported delay in launching?
a) Amphastar does not have sufficient product on hand to launch sooner.
b) Amphastar actually intends to launch quickly; the 4Q11 date in the PR is misdirection to confuse MNTA and thereby avert an injunction.
c) The ‘GrthzGd’ hypothesis: Because the potential damages from a lawsuit by MNTA are so large, Amphastar is stalling on the launch in order to obtain clarity on whether MNTA intends to sue.
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