Replies to post #174648 on Biotech Values

[ciotera]

Re: NCE

What if elvitegravir was already approved and the only new drug substance in Stribild was cobicistat - would that qualify?

[DewDiligence]

Congress introduces “Stribild” bill to legislate NCE status for FDCs that didn’t qualify under the FDA’s old interpretation:

http://blogs.wsj.com/pharmalot/2015/01/26/bill-is-introduced-to-provide-added-exclusivity-for-fixed-dose-drugs/

Stribild, which was approved by the FDA on 8/27/12, has only 3 years of Hatch-Waxman exclusivity because it did not qualify for NCE status under the FDA’s old interpretation for FDCs. (Note: The bill being introduced does not confer NCE status retroactively.)