Paragraph IV certifications

Paragraph IV certifications are legal declarations made by generic drug companies when they seek FDA approval to sell a generic version of a brand-name drug before the original patent expires. By certifying under Paragraph IV, the company asserts that the patent held by the innovator is either invalid or will not be infringed upon by their generic. This often initiates a legal process where the brand-name drug company may challenge the generic, and it can lead to patent disputes. Essentially, it is a formal statement that the generic company believes the patent is not enforceable or applicable.