Paragraph IV Is Pharma’s Most Profitable R&D Strategy
The average cost to develop a new drug reached $2.23 billion in 2024, with an expected ROI of just 5.9%. […]
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The Double Patenting Trap: How Pharma Brands Accidentally Invalidate Their Own Moats
Quick Summary: Obviousness-type double patenting (ODP) is a judicially created doctrine that prevents patent holders from stretching exclusivity by obtaining
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PAT-INFORMED for Drug LOE Dates: What Procurement Agencies and Analysts Get Wrong
The answer to whether you should use PAT-INFORMED to find drug patent loss-of-exclusivity dates depends entirely on who you are,
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Orange Book Delisting Wave: What the FTC Crackdown Means for Your Pipeline
Between September 2023 and May 2025, the Federal Trade Commission challenged more than 600 patent listings in the FDA’s Orange
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Do LLMs Recommend Branded Drugs More Often Than Generics?
When a patient types “Is there a cheaper alternative to Eliquis?” into ChatGPT, they expect an accurate, up-to-date answer. What
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The Hatch-Waxman Roadmap: How ANDA Filings and Patent Challenges Really Work
The Drug Price Competition and Patent Term Restoration Act of 1984, universally called Hatch-Waxman, created the legal architecture that now
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Four Secondary Patent Types That Extend Drug Exclusivity Beyond the Primary Patent
The primary compound patent on a drug is the one the industry talks about. It sets the nominal expiry date
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Inside the internet’s obsession with generics, brand names, coupons, biosimilars, and whether “the same drug” is actually the same drug
There’s a particular moment in modern medicine that produces more confusion than almost anything else in healthcare. It happens somewhere
Before They Launch: The Competitive Intelligence Playbook for Generic and Biosimilar Market Entry
The day a competitor files a Paragraph IV certification against your lead molecule, you have 45 days to file suit
