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Pharma Intelligence Alert: 2021 USFDA 505(b)(2) Approvals Study, UK Entresto SPC Ruling, & CDMO Sector Momentum

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 Two minutes to read. Executive Summary  In this edition of the API and IP Newsletter , we present findings from our retrospective analysis of all 2021 USFDA 505(b)(2) NDA approvals , tracking value-added reformulation strategies and top sponsors . In regulatory compliance and industry news, we cover Q1 CDMO financial growth across Gland, Akums, and Kwality, alongside the recent USFDA warning letter issued to Aurobindo Pharma’s Eugia Unit-I facility . In Intellectual Property, we unpack the UK High Court ruling in Accord Healthcare v. Novartis , which upholds the validity of the Entresto® (sacubitril/valsartan) SPC until January 2028 , effectively barring near-term generic launches . Key Highlights & Strategic Takeaways 1. Decoding Value-Added Formulations: Complete 2021 USFDA 505(b)(2) Analysis Approval Distribution: The 505(b)(2) pathway saw a total of 69 original approvals in CY 2021, characterised by a mid-year peak in June (16 approvals) and strong year-end momen...
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Pharma IP Alert: Tirzepatide P-IV Storm Hits FDA, US Generic Tariffs Loom, & Pfizer Tafamidis Discovery Ruling

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Summary: Two-minute read In this issue of the API and IP Newsletter , we break down the high-stakes Paragraph IV ANDA filings for Tirzepatide (Mounjaro & Zepbound) following the NCE-1 opening date . We also analyze proposed US generic drug tariffs of up to 200% , evaluate Patrys’ 505(b)(2) rapid injectable quetiapine for ICU delirium , and unpack a crucial Delaware District Court ruling on third-party discovery confidentiality in Pfizer v. Apotex (Tafamidis) . Key Highlights & Strategic Takeaways 1. Tirzepatide (Mounjaro / Zepbound) Paragraph IV Wave Massive Generic Interest:  On May 13, 2026, NCE-1 eligibility date, the FDA received four distinct categories of ANDA filings targeting Eli Lilly’s blockbuster molecule, which generated $36.5B in 2025 and holds a projected peak market of $50B–$65+B globally. Why 4 Different ANDA Entries? Driven by two distinct NDAs (Mounjaro for T2D vs. Zepbound for Obesity) and two delivery formats (Autoinjector Pen vs. Single-Dose Vial)...
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