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Contents First Generic Drug Approvals General information Aspire Biopharma Files Provisional Patent Application for Industry-First Sublingual Powder Formulation of Clopidogrel (Generic Plavix(R)) to Address Gastric Bleeding Risks Big Pharma Tight-Lipped on Details of API Stockpile Deals Intellectual Property Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd -(Australia) First Generic Drug Approvals The FDA’s 2025 First-Time Generic Drug Approvals list represents the very first generic alternatives to previously exclusive brand-name medications. This list is specific because it only includes first generics, which are the first versions of a drug that can be sold in the U.S. after patent protections and exclusivities on the brand-name version expire. Being the "first" generic approved carries significant strategic and financial advantages for a pharmaceutical company: 180-Day Market Exclusivity: The most significant advantage is that the first generic applicant (on...

Contents Recent P-IV filings General information Local division Mannheim imposes over €1.7 million penalty against Kodak FDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use Intellectual Property EirGen Pharma Ltd Vs DSM Nutritional Products AG Recent P-IV filings We follow P-IV filings on the FDA website. The recent update was on January 05, 2026. ANDAs with P-IV filing were recently filed for two products. Details are as follows. General information Local division Mannheim imposes over €1.7 million penalty against Kodak The local division Mannheim has ruled that Kodak has not complied with the conditions of a first-instance injunction in its printing plate dispute with FujiFilm. The US company must pay a substantial penalty, although the court rejected automatic enforcement by the UPC in non-EU countries such as the UK. News here FDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use M4Q(R2) is a globally harmonized framework for s...

Contents List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic General information AbbVie to cut drug prices, pledges $100 billion for research Bionpharma Inc. Receives USFDA Approval for Etravirine Tablets Developed in Collaboration with STEERLife Intellectual Property Agilent Technologies, Inc. Vs Axion Biosystems, Inc.: United States District Court for the District of Delaware. List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic The FDA maintains a list of approved new drug applications (NDA) that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA 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. December 2025 lists of off-patent, off-exclusivity drugs without an approved generic are published here. ...

Contents Content Recent ANDA approvals General information ScinoPharm Secures U.S. FDA Approval for Glatiramer Acetate Injection for the Treatment of Multiple Sclerosis Q1 2026: 5 FDA Decisions to Watch in the Realm of Oncology Intellectual Property BioNTech vs Withers & Rogers LLP Recent ANDA approvals We follow ANDA approvals. In December 2025, the USFDA issued 61 ANDA approvals, of which 12 were tentative. A tentative approval is a formal notification from the USFDA indicating that a generic drug application has met all scientific and regulatory requirements for safety, efficacy, and quality, but cannot be granted final marketing approval due to unexpired patents or market exclusivities held by the original brand-name drug. The companies that could seek more than two ANDA approvals (including tentative ones) in November were as follows. Some of our other comments about a few ANDA approvals sought by Indian companies are listed below. General information ScinoPharm Se...