WORLD OF GENERIC DRUGS MODULE

There are four types of patent certification FDA requires generic companies to submit:

• Patent not submitted to FDA: No patent is in existence and approval is effective after the Office of Generic Drugs (OGD) performs a scientific determination.
• Patent expired: The patent has expired and FDA can move forward with the review and potentially final approval.
• Patent expiration date (honored): The applicant company acknowledges that the key patents are still in effect. FDA will do the review in advance of the patent expiration date and grant tentative approval after the OGD scientific determination. Final approval is granted when the patent expires. The product cannot be sold until the patent and/or exclusivity expires.
• Patent challenge: The brand patent holder can file an infringement suit against the generic applicant. FDA approval to market the generic drug is automatically postponed for 30 months, unless before that time, the patent expires or is judged to be invalid or not infringed. This 30-month postponement allows the patent holder time to assert its patent rights in court before a generic competitor is permitted to enter the market.