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1.) June ANDA Approvals, Formulation Tech and 2.) CAFC Patent Decisions: Why the Federal Circuit Invalidated Enanta’s Protease Inhibitor Patent Against Pfizer

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Two minutes read Pharma Regulatory & IP Digest: June 2026 ANDA Approvals, Tech-Driven Formulations, and Landmark Federal Circuit Ruling Welcome to the Sidvim LifeSciences monthly briefing. This month, we cover key US FDA generic approvals, evolving formulation technology trends, and a major Federal Circuit patent decision on priority documentation. 1. USFDA ANDA Approvals Dashboard (June 2026) In June 2026, the USFDA granted 94 ANDA approvals , which included 11 tentative approvals . Tentative approvals indicate that a generic formulation meets all scientific and quality benchmarks but is held back from immediate commercial rollout due to unexpired patent terms or market exclusivities held by the innovator . The leading generic developers securing approvals during this period include: Alembic: 6 approvals Aurobindo & MSN: 5 approvals each Apotex, Micro Labs, Mylan, Teva, & Zydus: 4 approvals each Amneal & Macleods: 3 approvals each Concord Biotech, Sun Pha...
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1.) How Casper and Avyxa Are Using the 505(b)(2) Pathway to Drive Patient-Centric Formulation Innovation? 2.) Why the EPO Revoked Astellas’ Mirabegron Patent?

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Quick 2 minutes read Pharma Regulatory & IP Insights: June 2026 505(b)(2) Developments, Antitrust Closures, and EPO Case Law Keep up with the fast-evolving pharmaceutical landscape with our comprehensive digest of June 2026's key regulatory approvals, global commercial shifts, and landmark intellectual property litigation. 1. Landmark June 2026 505(b)(2) FDA Approvals The FDA's 505(b)(2) New Drug Application (NDA) pathway bridges the gap between high-risk new chemical entities and standard generics, allowing developers to introduce innovative changes to previously approved drugs . June 2026 saw significant patient-centric approvals in the rare disease and oncology support spaces . TIOCYSTIN® (Tiopronin) | Casper Pharma LLC (NDA #212927) Casper Pharma bypassed traditional generic ANDA routes to secure 505(b)(2) approval for TIOCYSTIN . While original immediate-release tiopronin tablets require strict fasting and create massive pill burdens, TIOCYSTIN introduces a unique 20...
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