Replies to post #179536 on Biotech Values

[DewDiligence]

Correct! DRTX’s Dalvance has non-patent Orange Book exclusivity until May 23, 2024. Dalvance was approved by the FDA on 5/23/14; it received 5 years of NCE exclusivity and an additional 5 years of ‘GAIN’ exclusivity as a novel antibiotic—10 years of exclusivity in all.

More discussion:
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/06/dalvance-gains-bonus-exclusivity-fda-grants-the-first-period-of-gain-act-exclusivity.html