The Drug Price Competition and Patent Term Restoration Act of 1984, universally called Hatch-Waxman, created the legal architecture that now […]

The primary compound patent on a drug is the one the industry talks about. It sets the nominal expiry date

There’s a particular moment in modern medicine that produces more confusion than almost anything else in healthcare. It happens somewhere

The day a competitor files a Paragraph IV certification against your lead molecule, you have 45 days to file suit

There is a narrow pricing band in pharmaceuticals where the math actually works. Price too high and payers route patients

Every blockbuster drug faces the same structural threat: the clock runs out on patent protection before the manufacturer has fully

A bottle of metformin 500 mg from Sun Pharma and a bottle of metformin 500 mg from a Tier-3 Indian

Every year, drug companies leave hundreds of millions of dollars on the table. Not because their molecules fail, not because

When Pfizer paid $11.6 billion for Array BioPharma in 2019, analysts praised the deal’s logic. Two years later, generic manufacturers