Replies to post #126763 on Biotech Values

[jq1234]

In ANDA review process, there is Labeling Review process as part of 5 parts review that included: Plant Inspection, Chemistry, Micro, Labeling, Bioequivalence.

[DewDiligence]

MNTA/Amphastar—Ramifications?

There are three cases:

1. Amphastar’s product is substitutable for branded Lovenox and Amphastar launches the product. In this case, MNTA would no longer obtain a 45% profit share on NVS’ sales of generic Lovenox, but rather would receive a low double-digit royalty on NVS’ Lovenox sales, and NVS’ sales would presumably drop from the additional competitor in the market. MNTA might sue Amphastar for patent infringement, but MNTA would have to seek damages from Amphastar—MNTA would not be able to recover lost income from NVS.

2. Amphastar’s product is substitutable for branded Lovenox, but MNTA blocks Amphastar’s launch by suing for patent infringement and obtaining an injunction. MNTA would continue to receive 45% of NVS’ Lovenox profits (as long as no other generic is launched).

3. Amphastar’s product is not substitutable for branded Lovenox. MNTA would continue to receive 45% of NVS’ Lovenox profits. For all practical purposes, this outcome would have no impact on MNTA’s economics.