Aptar N‑Sorb patent allowed by USPTO for packaging-based nitrosamine mitigation
- USPTO approved the foundational U.S. patent application for N‑Sorb technology.
- The patent covers the proprietary material composition and validated reduction of nitrosamines across multiple APIs.
- N‑Sorb can be deployed in blister systems, bottle formats (including drop‑in) and film‑based structures without changes to formulation or manufacturing.
- The application includes provisions that could support FDA Orange Book listing; N‑Sorb was accepted to the FDA Emerging Technology Program in August 2024.
Patent allowance
The United States Patent and Trademark Office has allowed the foundational U.S. patent application for N‑Sorb technology, covering both the proprietary material composition and demonstrated reduction of nitrosamine impurities.
Technology and performance
N‑Sorb is presented as a packaging-delivered mitigation platform with validated performance on drug products; the IP extends beyond traditional packaging claims to include finished-product nitrosamine reduction across multiple APIs known to be susceptible.
Regulatory implications
The patent application includes provisions that could support potential listing in the FDA Orange Book by tying claims to drug product performance, which Aptar says may enable enhanced regulatory and commercial protection strategies. The technology was accepted to the FDA Emerging Technology Program in August 2024.
Deployment
The N‑Sorb technology can be implemented across blister systems, bottle formats (including drop‑in solutions) and film-based structures without requiring changes to formulation or manufacturing processes.
Source: Aptar
