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Crystal Pharmatech Viewpoint: Analysis of Polymorph Patent Strategies for Small Molecule New Drugs Approved by the FDA in 2025

This whitepaper provides a comprehensive analysis of the polymorph patent landscape for the 46 new drugs approved by the FDA in 2025, with a specific focus on the 30 small molecule new molecular entities. By examining the administration routes and dosage forms, the report identifies 27 solid and semi-solid preparations, revealing that 81.5% of these products have established polymorph patent strategies—a testament to the critical importance of solid-state IP strategies.

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NJ Sites: Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey, USA 08512

2005 Eastpark Blvd, Cranbury, New Jersey, USA 08512

CA Site: 7133 Koll Center Parkway, Suite 200, Pleasanton, California, USA 94566
bd_global@crystalpharmatech.com (925) 558-5040