Teva’s ProAir HFA inhaler illustrates the gap better than any definition can. The active ingredient, albuterol sulfate, went off patent […]
Why Bioequivalence Is the Easy Part and Freedom to Operate Is the Cliff Read Post »
In 2007, a federal judge in the Southern District of New York ordered two generic drug companies to pay Takeda
AbbVie’s core patent on Humira, the one covering the adalimumab molecule itself, expired in January 2016. U.S. biosimilars did not
The Safe Patent Portfolio Trap: Why Minimal Filing Costs Pharma a Decade of Growth Read Post »
Teva Pharmaceutical Industries paid Pfizer and Takeda $1.6 billion in 2013. Sun Pharma paid another $550 million. The combined $2.15
The At-Risk Launch: When the Math Says Go, Even If the Court Says No Read Post »
Every generic and biosimilar developer knows the standard playbook. Wait for the composition-of-matter patent to run out, clear the Orange
Sue Early, Win Big: The Hidden ROI of Challenging Weak Method-of-Use Drug Patents Read Post »
Every generics attorney has heard some version of the same sentence from a nervous client: “They have over a hundred
The Evergreening Myth: How to Spot the Cracks in a 20-Patent Thicket Read Post »
Settling a Paragraph IV patent case feels like the safe choice. It ends the uncertainty, it gets a launch date
A generic company spends four years and fifteen million dollars fighting for the right to be first. It wins. It
The 180-Day Exclusivity Trap: Why First-to-File Winners Still Lose Money Read Post »
EpiPen’s last patent expired on September 11, 2025. Epinephrine has been off patent since the 1980s. For close to two
Why Device Patents Crack First: The Weakest Wall in Your Drug’s Patent Fortress Read Post »
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