Sidvim LifeSciences Private Limited

2026 Pharmaceutical IP & FDA Update: New 505(b)(2) Approvals and Patent Rulings The pharmaceutical industry is seeing a surge in innovation through the 505(b)(2) regulatory pathway and landmark decisions in the Unified Patent Court (UPC). This 06 April 2026 update covers critical developments in drug formulations, biosimilar settlements, and intellectual property litigation that impact market access and patient care. High-Impact 505(b)(2) FDA Approvals (March 2026) The 505(b)(2) NDA route is essential for manufacturers seeking to improve existing drugs, such as changing dosage forms or enhancing stability. The following approvals represent significant shifts in their respective therapeutic categories: 1. PYLARIFY TRUVU (Piflufolastat F-18) Manufacturer: Filed by Aphelion, an affiliate of Lantheus Holdings. Innovation: This 505(b)(2) application utilizes the original PYLARIFY as its Reference Listed Drug (RLD) but introduces a formulation allowing for 50% larger batch sizes. Mark...

The Future of Pharma: Key Insights from the March 2026 API and IP Newsletter Summary for this blog post: Staying ahead in the pharmaceutical industry requires a keen eye on Paragraph IV (P-IV) filings, intellectual property litigation, and regulatory shifts. This latest update covers significant developments in atopic dermatitis treatments, oral semaglutide legal battles, and landmark patent office decisions. Abrocitinib: The Next Big Frontier in Paragraph IV Filings The landscape for Abrocitinib (Pfizer’s Cibinqo) is shifting rapidly following recent FDA updates. As a selective JAK1 inhibitor indicated for refractory, moderate-to-severe atopic dermatitis, it represents a high-stakes market with 2025 US sales reaching approximately $115 million. Key Market Insights: NCE-1 Date: January 14, 2026. ANDA Activity: Three Abrocitinib ANDAs with P-IV certificates have been submitted to the FDA. Indian Market: Glenmark Pharmaceuticals recently launched the drug in India as Jabryus in par...

Contents Patent applications filed by Natco Pharma Limited General information FDA: Novo Nordisk failed to report deaths of weight-loss drug patients FTC monitoring how drug companies react to patent cliff, official says Intellectual Property Pfizer Inc., et al. v. Dexcel Pharma Technologies Limited, et al.: Tafamidis case Patent applications filed by Natco Pharma Limited We analysed Natco's patent application and evaluated its development activities. We tried to gather data on PCT applications filed over the last 2 years for this analysis. There is a lag in the publication of applications, so this analysis indicates Natco’s development activities from about 3-4 years ago. Some comments regarding PCT applications are summarised below. Some general comments Natco identifies molecules in very late stages of development, possibly in Phase III. Those patent families that are not interesting from a business perspective are abandoned immediately. There appears to be a robust ...

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...