Sidvim LifeSciences Private Limited

  Contents DMF filings in October 2024 General information Patent Litigation Impacts on US Biosimilar Market Entry West Virginia AG Reaches $17M Settlement With Pfizer and Ranbaxy Over Antitrust and Consumer Protection Violation Claims Intellectual Property Bausch and Lomb Vs Sandoz AG     DMF filings in October 2024   FDA publishes a list of DMF filings every quarter. The 4 th quarter (CY 24) list was published recently. This month, we are analysing October 2024 DMF filings. Of the 78 DMFs filed that month, 35 were submitted by Chinese companies and 28 by Indian companies.   The top DMF filing companies are listed below: Some of our other DMF-specific comments are as below. General information   Patent Litigation Impacts on US Biosimilar Market Entry 1. Patent litigation reform could accelerate US biosimilar market entry, which lags behind the EU due to protracted legal processes. 2. Biosimilar manufacturers face options like pre-clearance, "at-risk...

Contents General information 2024 Hatch-Waxman Year in Review Massachusetts AG Sues Insulin Makers and PBMs Over Alleged Price-Fixing Scheme Intellectual Property Honeywell International Inc.Vs Arkema France List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic   We regularly follow the USFDA website. There’s a wealth of information.   The FDA publishes a list of approved new drug application (NDA) drug products that are not under patent or exclusivity and for which the FDA has not approved an ANDA referencing that NDA drug product.    The FDA updates this list every six months (in June and December) to improve transparency and encourage the development and submission of ANDAs in markets with little competition.   Part I of the list identifies the drug products for which the FDA could immediately accept an ANDA without prior discussion.    Part II identifies drug products with potential legal, regulatory, or scientific issues that need ...