Posts

API & IP Brief: Cipla’s Patent Landscape, Halozyme Keytruda Injunction & FDA Approvals

Image
Summary 5-minute read API & IP Intelligence Brief: Cipla’s Patent Landscape, Subcutaneous Keytruda Injunction, and Landmark FDA Approvals Target Keywords: Cipla patent filings, ready-to-use injectables, green propellants pMDI, Halozyme vs MSD, Keytruda SC injunction, bepirovirsen FDA approval, Climara Pro generic, API solid-state polymorphs, 505(b)(2) strategy . Executive Summary The latest edition of the API and IP Newsletter (November 9, 2026) provides an analytical view of formulation-led generic differentiation, critical biopharma patent enforcement, and key US regulatory milestones: Cipla Patent Filing Landscape (Oct 2024 – Oct 2026): Cipla published 28 patent families dominated by delivery improvements and API solid-state forms (86%), pivoting toward ready-to-use (RTU) hospital injectables and low-GWP propellant inhalers rather than primary discovery . Halozyme Secures European Injunction Against MSD’s Keytruda SC: The District Court of The Hague barred MSD from m...

API & IP Brief: Dr. Reddy’s Patent Landscape, Semaglutide Revocation & Voquezna Updates

Image
API & IP Intelligence Brief: Dr. Reddy’s Patent Strategy & Semaglutide Patent Revocation Keywords: Dr. Reddy's patent filings, Semaglutide patent revocation, EPO Board of Appeal T 0187/25, Factor XIa inhibitors, API solid-state forms, skinny label generic, Voquezna ANDA litigation . Dr. Reddy’s Patent Landscape: Early-Stage Generic Positioning An analysis of 24 patent applications published between October 2024 and October 2026 highlights Dr. Reddy’s Laboratories’ (DRL) aggressive pre-loss-of-exclusivity (LOE) strategy . Small-molecule generic enablement accounts for 67% (16 filings) of the total, divided between API process/solid-state chemistry (38%, 9 filings) and differentiated dosage forms (29%, 7 filings) . The remaining pipeline spans biologics (13%), nutraceuticals (8%), digital health (8%), and a single new chemical entity (NCE) pan-KRAS degrader filing from Aurigene Oncology (4%) . DRL is building alternative crystal forms, salts, amorphous solid dispersion...