Pick the Right Pathway: How 505(b)(2) Beats the Branded Generic Every Time — Unless It Doesn’t
The Decision That Determines Your Revenue Ceiling Somewhere between completing a Phase II study and walking into an FDA pre-NDA […]
The Decision That Determines Your Revenue Ceiling Somewhere between completing a Phase II study and walking into an FDA pre-NDA […]
The Moment the Monopoly Ends On November 30, 2011, Lipitor lost its U.S. patent protection. Within 90 days, the price
The Problem With Waiting Every year, branded pharmaceutical companies watch billions in revenue walk out the door, and generic manufacturers
Drug companies don’t make drugs. They make time. Patents are the mechanism by which a pharmaceutical firm converts a decade
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The $3.5 Billion Miscalculation In 2011, Warner Chilcott and Allergan settled a Paragraph IV lawsuit over the branded proton pump
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The Five-Year Window Is Not Generous When a branded drug loses patent exclusivity, its manufacturer does not get to negotiate
How generic and 505(b)(2) developers mine expired and lapsed pharmaceutical patents for low-cost market entry The drug development world has
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The Patent Cliff Is Real, and So Is the Industry’s Response Every pharmaceutical executive knows the feeling. A blockbuster drug
The pharmaceutical industry manages intellectual property through three disconnected systems. The Food and Drug Administration (FDA) maintains the Orange Book
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