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Pharmaceutical Insights: March 2026 ANDA Approvals & IP Litigation Trends Stay updated with the latest developments in the global pharmaceutical industry. From the USFDA's March 2026 ANDA approvals to landmark Intellectual Property (IP) disputes involving Novo Nordisk and AstraZeneca, this newsletter covers critical regulatory milestones and market shifts USFDA ANDA Approvals – March 2026 In March 2026, the USFDA issued a total of 86 Abbreviated New Drug Application (ANDA) approvals, including 25 tentative approvals. A tentative approval signifies that while the generic drug meets all safety and quality standards, final marketing is delayed due to existing patents or exclusivities held by the brand-name manufacturer. Top Companies by ANDA Approvals Several leading pharmaceutical firms secured multiple approvals during this period. The companies sought more than 2 ANDA approvals in March 2026 are as follows. Aurobindo Pharma Ltd Dr. Reddy’s Laboratories Glenmark Pharmaceuti...

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...