The Ministry of Food and Drug Safety said on the 25th that it has posted on its website patent information for 507 drug items (including duplicates) whose data exclusivity and reexamination periods will expire within the next three years. The move is meant to help domestic drugmakers craft strategies to develop follow-on drugs (generics).
The disclosures include, by item, product name, company name, active ingredient, data exclusivity and reexamination end dates, whether a patent is listed, patent number and expiration date, and production and import records.
Under the current system, follow-on drugs can apply for approval only after the original drug's data exclusivity or reexamination period ends. Using the published patent information, drugmakers can prepare in advance strategies such as patent avoidance or patent invalidation.
Separately, for the top five items by production and import volume (including fexuprazan formulations and botulinum formulations), the ministry will also provide unlisted patent information related to the ingredients, in addition to listed patents.