Sidvim LifeSciences Private Limited

Contents ANDA approvals-February 2026 General information Generics suspect GSK of playing “divisional game” after EPO revocation CDSCO issues advisory against promotion of prescription obesity drugs Intellectual Property Astellas Pharma Inc. v. Ascent Pharmaceuticals, Inc., ANDA approvals-February 2026 We follow ANDA approvals. In February 2026, the USFDA issued 91 ANDA approvals, of which 24 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 February were as follows. Some of our other comments about a few ANDA approvals sought by Indian companies are listed below. General information Generics suspect G...

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...