Non-Patent Exclusivity and 180-Day Exclusivity Forfeiture Slides Posted

Last week, I gave a talk about non-patent exclusivity at ACI's FDA Boot Camp conference in Boston.  The talk covered new chemical entity (5-year) exclusivity; new clinical trial (3-year) exclusivity; orphan drug exclusivity; pediatric exclusivity; and generic drug (180-day) exclusivity.  You can download a copy of my slides here.

In June, I gave a talk about forfeiture of 180-day exclusivity at IIR's Generic Drugs Summit conference in Washington.  The talk included a discussion of the "failure to market" forfeiture provisions, particularly the FDA's Acarbose and Granisetron decisions.  You can download a copy of those slides here.

Comments

[M.R.Syam Sundar]

Excellant and simple to understand