Monday, January 09, 2017

How is Teva's MS drug Copaxone doing

Pantagraph talks about possible investor concerns over Teva/Copaxone:

For example, concerns over Copaxone are largely overstated. Teva Pharmaceutical was able to reformulate Copaxone into an extended-release medication that only needs to be taken three times a week. The patent loss on Copaxone, and what generic drugmakers will be producing, is a less desirable, more frequent once-daily injection. With Teva able to keep its Copaxone brand-name intact and offer multiple sclerosis patients and physicians the same therapy with even more convenience, it's unlikely to lose much in the way of revenue. In other words, Copaxone should remain a $4 billion drug, annually.

link to Pantagraph:

Patents covering "three per week" dosing were not at issue in the Supreme Court case of Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015).

But see also
Teva loses on 40mg Copaxone (for MS) at PTAB

Separately, from on 9 January 2017:

Impax Laboratories, Inc. IPXL announced that it has filed an Abbreviated New Drug application (ANDA) with the FDA for a generic version of Sanofi's Aubagio (teriflunomide) tablets, 14 mg. Aubagio has been approved for the treatment of relapsing forms of multiple sclerosis (MS).


Sanofi has filed a patent infringement lawsuit against Impax in the U.S. District Court for the District of Delaware.


The ANDA of Impax contained a paragraph IV certification.


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