Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

The current US market for the 20mg formulation of Copaxone has an annualized run rate of about $1.1B. For the sake of discussion, let’s say this shrinks to a $900K run rate on 9/1/15, which implies about $300M during a 4-month period. If NVS/MNTA have the only approved generic and they launch on 9/1/15, then it’s not unreasonable to think they could garner $100M of sales during the ensuing four months.

Teva’s 40mg formulation of Copaxone is protected by a US patent, but NVS/MNTA may think they can get the patent invalidated due to obviousness. The FDA can’t approve a generic version of the 40mg product until the 30-month Hatch-Waxman stay expires in Feb 2017—unless there is a legal ruling invalidating the 40mg patent before then.