Pharma IP Alert: Tirzepatide P-IV Storm Hits FDA, US Generic Tariffs Loom, & Pfizer Tafamidis Discovery Ruling
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)...
