September 2026 505(b)(2) Approvals Breakdown, Vanda v. Teva Non-Infringement Victory, & Sanofi’s $8B Mega-Deal
Summary of the blog: 5-minute read API & IP Intelligence Roundup (05 October 2026) This edition evaluates the latest wave of 505(b)(2) NDA approvals addressing unmet clinical needs across multi-billion-dollar oncology, metabolic, and cardiovascular markets, landmark pharmaceutical deals, and a critical Delaware Federal Court ruling applying the Supreme Court’s Hikma precedent to insulate generic tasimelteon from late-stage continuation patent claims . 1. September 2026 505(b)(2) NDA Approvals & Tentative Approvals The FDA granted final and tentative approvals to five differentiated 505(b)(2) formulations that bypass reference-product administration hurdles or innovator patent thickets : OMCAZIO (Cabozantinib Laurylsulfate, NDA #220613 – Handa Oncology LLC): Final Approval for oral capsules (11.5 mg, 23 mg, 34.5 mg) referencing Cabometyx (~$1.4B US sales) . Formulated as a novel laurylsulfate salt with enhanced oral bioavailability that can be taken with or without food...
