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 ...
