Who this is for: Formulation scientists, regulatory affairs directors, IP counsel, and business development executives at generic and specialty pharmaceutical […]

Every year, somewhere between $20 billion and $80 billion in branded drug revenue falls off a cliff. Not metaphorically. Literally:

In the summer of 2022, a mid-sized generic manufacturer’s legal team spent six weeks and roughly $400,000 running keyword searches

Every formulation patent is a public confession. The inventor must disclose, in precise technical detail, exactly what makes the product

Biologic drugs account for roughly 2% of all U.S. prescriptions. They generate 37% of total net drug spending [1]. That

When Mylan filed its first abbreviated new drug application (ANDA) for a controlled-release oxycodone formulation, AstraZeneca’s legal team didn’t panic

Biologic drugs represent 2% of all U.S. prescriptions but consume 37% of net drug spending. [1] That arithmetic explains everything

Every year, hundreds of millions of dollars shift hands based on a single question: who filed first? The Paragraph IV

The $236 Billion Blind Spot Every supply chain director in pharmaceuticals knows the standard risks: a manufacturer fails a GMP