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API and IP Newsletter

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                                                                                               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...

API and IP Newsletter

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Contents Patent applications filed by Sun Pharma Advance Research Company Limited General information $275 Million Sandoz Settlement Partially Resolves Generic Drug Price-Fixing Litigation Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement Intellectual Property Merck Sharp & Dohme B.V Vs Aurobindo and others   Patent applications filed by Sun Pharma Advance Research Company Limited   We follow patent applications filed by Indian companies, which helps us understand their direction, including the kinds of products, technologies, and licensing activities they focus on.   This week, we analysed Sun Pharma's patent portfolio. We have analysed PCT patent filings by Sun Pharma Advanced Research Company Limited (SPARC).    Some of our comments are as follows. The list of all PCT filings by Sun Pharma Advanced Research Company Limited is as follows: all patent families are down...