Dew,
I read the CS report on this after Mylan won the lawsuit and it isn't the 1st time I've seen the term 'later this year' used. I haven't a clue why they don't think the event is imminent, unless they are referring to a non at-risk launch
Loss of Copaxone 40mg/mL Patents Another Step Towards Likely Generic Competition
¦ Bottom Line:
The long-awaited decision from the U.S. District Court on four Orange Book listed patents for the 40mg/mL dose of Copaxone went against TEVA, representing another step towards the entry of generic versions of the 40mg/mL dose into the US market. We already conservatively assume 2017
generic competition in our TEVA base case so today’s news does not lead us to change our current estimates. We expect Novartis/Momenta and potentially one other competitor to launch later this year and lead to pricing pressure on the brand, while the volume impact will likely take a little longer based on the relatively slow initial uptake we saw from Glatopa (generic version of Copaxone 20mg/mL).
¦ Several steps still to go:
We spoke to TEVA and expect them to appeal tonight’s decision, while also requesting a preliminary injunction preventing the launch of any generic version until the legal process around all of the outstanding patents has been completed. In addition to the four patents included in this decision, TEVA has also filed suit against the potential competitors on a 5th and 6th patent, with court cases expected in the 2018 timeframe. The IPR appeals process is also ongoing, with a decision expected in late 2017/early 2018. Finally, beyond the legal decisions, the competitors all still need to obtain FDA approval prior to being able to launch.
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