API and IP Newsletter

Contents Recent P-IV filings General information Global Trends in R&D 2025 Cassava Sciences must face malicious prosecution lawsuit over Alzheimer's drug Intellectual Property T 2275/22 (Glaucoma II/SANTEN) 25-02-2025 Recent P-IV filings On March 17, the FDA’s website published the list of new Paragraph IV (P-IV) filings. We track P-IV filings as they appear on the FDA site. What are P-IV filings? When a generic company submits an Abbreviated New Drug Application (ANDA), it must include a certification stating that one or more patents listed in the Orange Book for the brand-name drug ar...