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USFDA July 2026 ANDA Approvals: Indian Pharma Dominance, Antidiabetic Waves, US Tariffs, & EPO Patent Insights

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Two minutes read Summary: USFDA ANDAs & Global Pharma IP Roundup The US generic landscape in July 2026 saw rapid momentum across complex generics, notable patent expiries, and supply-chain realignments . This month’s intelligence roundup breaks down the 52 USFDA ANDA decisions , evaluates US generic drug tariff reshoring metrics , and examines an essential EPO Technical Board of Appeal patent revocation ruling . 1. July 2026 USFDA ANDA Approvals: Key Trends The USFDA granted 46 final approvals and 6 tentative approvals (TAs) across global manufacturers . Indian Generic Pharma Dominance: Indian drugmakers captured 46% of all regulatory decisions (20 final approvals, 4 TAs) . Aurobindo led with 3 approvals (Etodolac, Bupropion, Adapalene/Benzoyl Peroxide), followed by Macleods (Chlorthalidone, Dapsone), Zydus (Fluvoxamine, Edaravone), and Laurus Labs (Rilpivirine, TAF) . Antidiabetic Wave in Tentative Approvals: Five of the six tentative approvals focused on blockbuster an...
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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...
Location: Mumbai, Maharashtra, India
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