patent linkage

Patent linkage refers to the connection between drug patents and the approval of generic drug applications. When a new drug is developed and patented, the patent holder can keep competitors from selling a similar product until the patent expires. In some countries, regulatory authorities must consider the patent status before approving generic versions. This means that a generic drug can't enter the market until any relevant patents have expired or been resolved, which can impact medication availability and pricing. Patent linkage aims to encourage innovation while balancing access to affordable medicines.