I. The 505(b)(2) Pathway: What It Is and Why Analysts Keep Undervaluing It The 505(b)(2) pathway is the most structurally […]

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.

There is a question that gets debated in congressional hearings, litigated in federal courts, and studied in academic journals with

943 drugs approved. $15M to $100M in development costs versus $2.6B for an NCE. One regulatory mechanism sits at the