What are the time periods of new drug product exclusivity?
A 5-year period of exclusivity is granted to new drug applications for products containing chemical entities never previously approved by FDA either alone or in combination. No 505(b)(2) application or ANDA may be submitted during the 5-year exclusivity period except that such applications may be submitted after 4 years if they contain a certification of patent invalidity or noninfringement. A 3-year period of exclusivity is granted for a drug product that contains an active moiety that has been previously approved, when the application contains reports of new clinical investigations (other than bioavailability studies) conducted or sponsored by the sponsor that were essential to approval of the application. For example, the changes in an approved drug product that affect its active ingredient(s), strength, dosage form, route of administration or conditions of use may be granted exclusivity if clinical investigations were essential to approval of the application containing those change
