The Reformulation Everyone Treats as an R&D Decision Is Actually a Patent-Timing Decision
The FDA approved Keytruda Qlex on September 19, 2025. [12] Merck lists the US expiry year of the original Keytruda
October 2026
Your Second-Source Qualification Timeline Is Longer Than Your Freedom-to-Operate Window
FDA aims to act on a standard prior approval supplement in 6 months, or 10 months if the agency must
Your Second-Source Qualification Timeline Is Longer Than Your Freedom-to-Operate Window Read Post »
On-Time Delivery Metrics Miss Day One of Generic Entry
Glenmark launched generic Zetia in the United States on December 12, 2016. IMS Health data cited in the company’s release
On-Time Delivery Metrics Miss Day One of Generic Entry Read Post »
The Expiring Patent List Is Not a Business Development Strategy
Eliquis has a composition-of-matter patent listed to expire on November 21, 2026 [1]. Generic apixaban cannot launch in the United
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Global Patent Expiration Tracking in Excel: Where the Spreadsheet Breaks
A single Excel worksheet holds 1,048,576 rows and 16,384 columns. [1] That limit is not the main problem with a
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A Patent Expiry Date Is Not a Pharma Partnership Plan
Novo Nordisk’s Canadian semaglutide patent, CA 2601784, lapsed because a maintenance fee went unpaid in 2019. The fee was CAD
A Patent Expiry Date Is Not a Pharma Partnership Plan Read Post »
500 Drugs, 5 Years: What to Do With a Patent Expiry List
Merck reports that the main US patent on Keytruda expires in 2028, and the same table shows 2031 for the
500 Drugs, 5 Years: What to Do With a Patent Expiry List Read Post »
Philippines Drug Patent Expiration: Why the US Date Is the Wrong Clock
Pfizer lost US exclusivity on Lipitor on November 30, 2011. [1] The EU compound patent for the same drug expired
Philippines Drug Patent Expiration: Why the US Date Is the Wrong Clock Read Post »
Patent Expiration vs. Commercial Opportunity: Why the Date Is Not the Launch
The Eliquis composition patent in the FDA Orange Book expires on November 21, 2026. [1] Bristol Myers Squibb and Pfizer
Patent Expiration vs. Commercial Opportunity: Why the Date Is Not the Launch Read Post »
