Stop Calling It “Loss of Exclusivity” — For Most Drugs, It’s Loss of Pricing Power, Not Loss of Revenue
Nine months after Humira lost U.S. exclusivity, biosimilars held four percent of the market. AbbVie’s Humira still controlled ninety-six percent
Insights
The Prior Art Edge: Why Search Quality Beats Legal Firepower in Drug Patent Litigation
In 2023, Mylan filed an inter partes review against Novo Nordisk’s U.S. Patent No. 8,536,122, the compound patent covering semaglutide,
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The Authorized Generic That Beats the Patent Cliff to Market
On November 30, 2011, Ranbaxy Laboratories was supposed to be the only company selling a generic version of Lipitor. It
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The Gap Between a Defensible Drug Patent and a Listed Patent Is Bigger Than Most Portfolios Admit
The Short Answer A patent’s presence in the FDA Orange Book proves it was submitted and accepted for listing. It
One Day Late, Nine Figures Short: What Being the Second First-to-File Actually Costs
The Short Answer: Under FDA’s interpretation of the Hatch-Waxman Act, “first applicant” status on a Paragraph IV certification is determined
One Day Late, Nine Figures Short: What Being the Second First-to-File Actually Costs Read Post »
The Three-Year Head Start: How to Spot a Skinny-Label Opportunity Before Anyone Else Reads the Patent
In March 2002, Teva filed an ANDA for generic carvedilol targeting a patent that would not expire for five more
The Myth of the Stable Drug Patent: Why IPRs Change the Game Overnight
On October 31, 2025, the director of the U.S. Patent and Trademark Office denied institution of thirteen inter partes review
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Predictable by Design: How Brands Outmaneuver Your Paragraph IV Strategy
A Paragraph IV certification feels like an ambush when a generic company files it. It rarely is one for the
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The First-Filer’s Trap: Why 180-Day Exclusivity Fails Without a Supply Chain Moat
Ranbaxy won the most valuable prize in generic pharmaceuticals — first-to-file exclusivity on generic Lipitor — while two of its
The First-Filer’s Trap: Why 180-Day Exclusivity Fails Without a Supply Chain Moat Read Post »
