Momenta Pharmaceuticals, Inc. (MNTA)

[JOlsen114]

"If the inventory NVS/MNTA built “aggressively” starting on 5/25/14 expires due to shelf life, it will mean that the FDA hasn’t yet approved the Copaxone ANDA in May 2016, and MNTA will be in serious trouble regardless. Thus, the shelf life of Copaxone should not be one of your main concerns as a MNTA long. Regards, Dew"


I agree this is the least of our current worries but a potential drag on Earnings we should be aware of.

The brand has a shelf life of two years but that does not mean Momenta's product will have two years of shelf life. It is not uncommon for a generic to a shorter life for than the brand. The life is set by the applicant based on the amount of stability data the company has generated.

The wholesalers generally require 15 months of remaining shelf life on a product when it arrives at their docks so if the product has two years of shelf life starting in May (clock starts when batch begins manufacture)MNTA would have until January 2015 to ship or they will have to make fresh product. Wholesalers may take short dated product at a discount but I would want MNTA to have fresh product ready because that's what the customer wants.

All the potential competitors are in the same boat.