MFDS Releases Patent Information on Drugs with Expiring Data Protection Periods

507 Products Subject to Data Protection and Re-examination Expiring Within Three Years

The Ministry of Food and Drug Safety announced on November 25 that it will release patent information listed in the drug patent list for 507 products whose data protection and re-examination periods are set to expire within the next three years. This initiative aims to assist in establishing development strategies for domestic generic drugs.

Ministry of Food and Drug Safety

The disclosed patent information for the listed products includes the product name, company name, main ingredient, expiration date, whether a patent is listed, listed patent number, listed patent expiration date, and production/import performance.

Applications for marketing authorization of generic drugs for products subject to data protection and re-examination are only possible after the respective period has ended. Companies can utilize the disclosed information when establishing patent circumvention strategies or patent invalidation strategies for product development.

In particular, for the top five products by production/import performance in categories such as fexuprazan preparations and botulinum preparations, additional information on unlisted patents related to the respective ingredients will be provided, in addition to the listed patent information.

The Ministry expects that providing this information will help invigorate the domestic generic drug market and will continue its efforts to create a stable supply environment for pharmaceuticals in Korea.