The Manufacturing Capacity You Reserved for Launch Day Assumes Nobody Else Read the Same Calendar
Seven adalimumab biosimilars reached the US market in the same week of July 2023. [1] Two generic versions of Entresto
Why the Best CDMOs Track Patent Litigation Dockets and the Rest Just Track Your PO
On October 9, 2025, Novo Nordisk confirmed that FDA had given its Bloomington, Indiana plant an Official Action Indicated (OAI)
Why the Best CDMOs Track Patent Litigation Dockets and the Rest Just Track Your PO Read Post »
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
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
The Expiring Patent List Is Not a Business Development Strategy Read Post »
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
Global Patent Expiration Tracking in Excel: Where the Spreadsheet Breaks Read Post »
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 »
