Aptar Active Material Science, a division of AptarGroup, Inc., has reached an important intellectual property milestone after receiving approval from the United States Patent and Trademark Office (USPTO) for its foundational U.S. patent application covering N-Sorb Technology. Announced on June 9, 2026, the development strengthens the company’s nitrosamine risk mitigation platform and introduces a packaging-based approach designed to address nitrosamine impurities in pharmaceutical products. According to Aptar Active Material Science, the patent application combines proprietary material science innovation with demonstrated performance on drug products, creating a packaging-delivered solution intended to support pharmaceutical manufacturers in managing nitrosamine-related concerns.
The technology has been designed for use across a range of packaging formats, including blister packs, bottle systems and film-based structures. Aptar stated that implementation can occur without requiring modifications to existing formulations or manufacturing processes. The patent application covers both the proprietary material composition and validated reductions of nitrosamines across several active pharmaceutical ingredients (APIs) identified as having susceptibility to nitrosamine formation. By linking packaging performance directly to impurity reduction, the company said the platform extends beyond conventional packaging intellectual property and focuses on product protection outcomes. This positions N-Sorb Technology as a performance-oriented solution for pharmaceutical packaging applications.
The patent application also contains provisions that may support potential inclusion in the FDA Orange Book, which lists FDA-approved drug products based on safety and effectiveness. Aptar noted that the application demonstrates performance on drug products within the scope of the claims and specifically identifies numerous APIs associated with nitrosamine susceptibility. The company said pharmaceutical partners adopting the technology could potentially pursue additional regulatory and commercial protection strategies connected to finished-product performance.
“This milestone marks a fundamental shift in how the industry can address nitrosamine risk,” said Badre Hammond, VP, Global Commercial Operations and GM, APAC for Aptar Active Material Science. “For the first time, we are bringing together advanced material science and demonstrated drug product performance within a single IP framework. That combination creates a powerful new lever for our pharmaceutical partners to mitigate risk and establish differentiated regulatory and commercial positions (i.e. Orange Book listing). This is a platform innovation with broad implications for product integrity, lifecycle management, and patient safety.”
The company also highlighted that in August 2024, the technology was accepted into the U.S. Food & Drug Administration’s Emerging Technology Program (ETP), an initiative intended to address technical and regulatory considerations for novel technologies before regulatory submissions are made.
