Biotech Values

[DewDiligence]

MNTA—Addendum re 180-day exclusivity for 40mg Copaxone:

The reason for the uncertainty in MYL’s PR yesterday about 180-day Hatch-Waxman exclusivity (#msg-135115294) is that multiple companies—including MYL and NVS/MNTA—are designated as H-W “first filers” on 40mg Copaxone. This situation arose because multiple companies submitted their Paragraph-IV challenges on the same day (the day TEVA added its first 40mg Copaxone patent to the FDA’s Orange Book).

My understanding is that if the FDA approves a 40mg generic from other first-filer applicants (including NVS/MNTA) within six months of yesterday’s MYL approval, all approved 40mg products from first-filers will share the (remaining amount of) 180-day H-W exclusivity.

In other words, 180-day H-W exclusivity will have no effect on anybody unless the FDA approves a 40mg generic in the next six months from a non-first-filer applicant, which is highly unlikely, IMO.