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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P-IV filings General information Local division Mannheim imposes over €1.7 million penalty against Kodak FDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use Intellectual Property EirGen Pharma Ltd Vs DSM Nutritional Products AG Recent P-IV filings We follow P-IV filings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 News here FDA Releases Draft Guidance on Registering Pharmaceuticals for Human Use M4Q(R2) is a globally harmonized framework for s...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...

Contents Recent 505 (b) (2) filings General information Almost 85% of overcharged amount claimed by NPPA yet to be recovered CNIPA- The Added Value of Patent-Intensive Industries Nationwide in 2024 was 18,038.1 Billion RMB, Accounting for 13.38% of GDP Intellectual Property Mandeep Singh Vs Shabir Momin: Instant Bollywood Recent 505 (b) (2) filings We follow 505 (b) (2) filings. Generally, 505(b)(2) NDAs relate to changes compared to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). More details 505 (b) (2) FDA approvals can be found here. This month, some of the 505 (b) (2) applications filed by the Brand companies are for marketing differentiated dosage and dosage forms, sometimes for different patient populations. The details of December 2025, 505 (b) (2) filings are as follows: General information Almost 85% of overcha...

Content Recent Paragraph-IV filings General information 2026 & beyond: Indian pharma hinges hopes on innovation impetus & regulatory agility How GLP-1s, Digital Tech, and 505(b)(2) Strategies Are Reshaping the CDMO Landscape Intellectual Property Merck vs Hopewell : Mavenclad (cladribine) Recent Paragraph-IV filings We follow ANDA filings with P-IV certificates. The FDA published the recent list on December 15. Avacopan Three ANDAs seems to have been filed on the NCE-1 date. While the specific names of the generic filers are typically withheld in initial FDA listings, major generic players such as Teva and Sandoz are often among the first to file (FTF) for such high-growth orphan drugs. Sandoz has filed a patent family for the crystalline form, WO2022263263. Teva filed a patent family for Avacopan intermediates, WO2023158722A2. Tavneos is a first-in-class oral C5a receptor antagonist used as an adjunctive treatment for adults with severe active ANCA-associated va...