Replies to post #9404 on Momenta Pharmaceuticals, Inc. (MNTA)

[io_io]

Thus, in this instance, the FDA can be barred from issuing a final approval of MNTA’s Copaxone ANDA only by an explicit Order from the Court.

Dew, your logic is complete nonsense.

Look at VVUS, for whom the FDA just approved Qnexa; or IDIX, the FDA approved their Hep-B drug 6 years ago. If an ANDA was filed tomorrow, could the FDA approve it, this year or next year?

These drugs have valid patents listed in the Orange Book. So, of course the FDA can't give final approval for an ANDA.

Now look at Copaxone. Two or more ANDAs have been filed by MNTA, Mylan etc. Could the FDA approve them?

The only difference is that the District Court has:
a) Affirmed that the TEVA patents are valid.
b) Ruled that each of these two ANDAs filings has infringed the TEVA patents.
So, again Copaxone has valid patents listed in the Orange Book, and of course the FDA can't give final approval for an ANDA.