Posts

Pharma Market Briefing: Q2 2026 USFDA Type II DMF Filings, 505(b)(2) Strategy & EPO Updates

Image
Two minutes of quick reading Pharma Regulatory & IP Insights: Q2 2026 USFDA DMF Trends, 505(b)(2) Value Drivers, and EPO Process Patent Rulings Welcome to the latest Sidvim LifeSciences market briefing . This week, we analyse the Q2 CY 2026 USFDA Type II Drug Master File (DMF) submissions , ongoing legal and regulatory shifts in weight-loss therapies, strategic advantages of the 505(b)(2) pathway, and a landmark European Patent Office (EPO) Board of Appeal decision on chemical process claims . 1. Q2 CY 2026 USFDA Type II Drug Master File (DMF) Submissions Overview Monitoring quarterly DMF filings offers valuable business insights on the generic pipeline and highlights opportunities for API suppliers to provide APIs to formulators targeting upcoming Paragraph IV/NCE-1 filings in the US.  During Q2 2026 (April 1 to June 30, 2026),  243 Type II DMFs  were submitted to the USFDA by 165 companies. Geographic Distribution: China Maintains Volume Lead Over the last 2–3 yea...
Read more

Pharma & Veterinary Briefing 2026: FDA Green Book Exclusivities, Advanced Manufacturing, and Key IP Decisions

Image
Quick 2-minute reading Pharma Regulatory & IP Digest: Veterinary Drug Exclusivities, Distributed Manufacturing, and Landmark D.C. Circuit Patent Ruling Welcome to the Sidvim LifeSciences monthly briefing. This month, we cover key developments in the 2026 veterinary drug market, new USFDA manufacturing proposals, an impactful PBM lawsuit settlement, and a critical appellate decision regarding post-trial ANDA modifications. 1. USFDA Green Book 2026: A Deep Dive into Veterinary Drug Exclusivities The veterinary medicine sector has seen approximately 16 animal drug approvals so far in 2026, encompassing 6 New Chemical Entities (NCEs) and 10 Lifecycle Management (LCM) expansions . While human pharmaceutical data packages follow Section 505 of the FD&C Act, the legal architecture for animal health is governed strictly by Section 512 and administered by the Centre for Veterinary Medicine (CVM) . The framework breaks down into two core exclusivity shields for New Animal Drug Applicat...
Location: Mumbai, Maharashtra, India
Read more