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FDA Q3 2026 DMF Filings, Delhi HC Patent Ruling & Biocon BPCIA Settlement

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Summary: 5-minute read The latest intelligence update covers US FDA Drug Master File (DMF) trends for Q3 2026, landmark pharmaceutical IP jurisprudence from the Delhi High Court, and key regulatory and biosimilar litigation settlements . 1. US FDA Q3 2026 Type II DMF Filings Landscape A total of 316 Type II (Drug Substance) DMFs were submitted in Q3 2026, with India and China accounting for over 85% of total volume : Geographic Distribution: China led with 148 filings (47%), prioritising peptide therapeutics (Semaglutide, Tirzepatide, Orforglipron), exosomes, and bioprocessing media . India followed with 123 submissions (39%), focusing on small-molecule oncology kinase inhibitors, cardiometabolic therapies, and complex anti-infectives . The US and Rest of World accounted for 5% (17) and 9% (28), respectively . Top Filing Entities: Suyog Life Sciences topped the rankings with 11 filings (primarily key starting materials and advanced intermediates), followed by Apitoria Pharma...
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  Global API & IP Intelligence Brief: P-IV Filings, EPO Jurisprudence & Regulatory Shifts High-Value Paragraph IV Filings Recent FDA Paragraph IV submissions highlight key strategic generic entries targeting high-barrier extended-release formulations and multi-billion-dollar brand franchises : Deutetrabenazine ER Tablets (18 mg): Targets Teva’s Austedo XR ($1.6B–$2.5B in US sales) . With only one ANDA submitted for this strength, the applicant has sole First-to-File (FTF) status and a 180-day exclusivity opportunity, facing patents extending through October 2041 . This follows Teva's ongoing New Jersey litigation against earlier ER filers and its 2022 settlements on immediate-release tablets . Ruxolitinib Phosphate ER Tablets (11, 22, 33, 44, and 55 mg): Targets Incyte’s Jakafi XR ($2.6B–$3.0B+ US sales) . A single applicant filed across all five strengths, positioning itself for exclusive 180-day marketing exclusivity . Litigation will focus on sustained-release ...
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