This paper was originally published by Ingrid Freije, Stéphane Lamouche, and Mario Tanguay in Therapeutic Innovation & Regulatory Science under

Generic drug makers must tailor European market entry strategies to each country. Moreover, they must address the sequence in which they want to enter markets.

Drug patent expiration doesn’t always mean generics enter the market right away. Many factors affect generic drug launches and drug formulary changes.

There’s no reason to assume that every branded drug will fall victim to the “patent cliff.” Actions taken before drug patent expiration can extend drug life cycles.

Artificial intelligence is allowing chemists to find new way to synthesize drug molecules, and forcing drug developers to shore up their patent strategies.

Recently a presentation by an Israeli patent examiner was brought forward in an argument against patent evergreening. In her presentation,

1. Introduction to the 505(b)(2) Pathway In the complex world of drug development and approval, the 505(b)(2) pathway stands out