Every dated event that moved a loss-of-exclusivity date or changed a drug's outlook: settlements that pushed dates back, US generic and biosimilar launches, launches outside the US, Medicare price negotiation and acquisitions by the most exposed companies. Follow it with the RSS feed.
Formycon and Zydus's FYB206 is the first publicly announced Keytruda biosimilar under FDA review; a decision is expected in Q3 2027. Merck's primary US compound patent expires in December 2028. Formycon and Zydus
Hetero's capsules are approved, but AbbVie still expects no US generic before 30 March 2032. FDA Orange Book
Natco joins Apotex, Lupin and Macleods with FDA approval; settlement terms are undisclosed and Gilead puts US exclusivity at 2031. FDA Orange Book
Lilly received notice that multiple companies had applied to sell generic tirzepatide before its patents expire, and said it intends to sue. Its US compound patent runs to 2036. Lilly 10-Q, Q2 2026
Dr. Reddy's launched the first generic in Canada, after generics reached India in the first quarter. US protection runs to 2032. Dr. Reddy's
Pfizer settled with Dexcel, Hikma and Cipla, extending the effective US patent expiry to 1 June 2031, subject to a case against Apotex. Pfizer had expected US sales to fall from 2029. Pfizer Q1 2026 results
Launch still waits on patents: the last listed Xtandi patent expires in August 2027. FDA Orange Book
Breckenridge launched generic pomalidomide under the settlement timeline, with Camber following. Breckenridge
Settlements with Lupin, Cipla and Laurus Labs bar generics before 1 April 2036, more than two years after Gilead's previous December 2033 estimate. Fierce Pharma
AbbVie settled with every generic filer. Analysts had modeled US exclusivity ending in 2032. Fierce Pharma
Amgen's Wezlana launched in January 2025, and several more biosimilars followed during the year. Stelara sales fell 41% in 2025. Center for Biosimilars
Takeda moved its assumption from May 2026 by three to five years, citing formulation, dosing and manufacturing patents. Pharma Japan