Q1 2026 Global Pharma Insights: USFDA DMF Filing Trends and the Landmark EPO Revocation of Biogen’s Dimethyl Fumarate Patent
Q1 2026 API & IP Insights: DMF Filings, GLP-1 Litigation, and Major Patent Revocations The first quarter of 2026 has seen a significant shift in the pharmaceutical landscape, with 379 new Type II DMFs filed at the USFDA. While Indian and Chinese companies continue to dominate the volume of filings, the focus has moved sharply toward Complex APIs and New Oncology molecules, such as Fruquintinib and Tirzepatide. For industry professionals, these filings represent the first clear roadmap for generic competition in the coming decade. 1. Q1 2026 DMF Filing Trends: India and China Lead the Charge The USFDA recently released the DMF filing list for the first quarter of 2026, revealing a total of 379 Type II DMFs submitted. The data shows a clear dominance by Indian and Chinese manufacturers, particularly in the "New APIs" and "Speciality" categories. Breakdown by Category: New APIs / Speciality: ~160 DMFs from India; ~136 from China. Complex APIs: 18 fi...