### Question
What is the definition of 180-day exclusivity period?


### Answer
The definition of **180-day exclusivity period** is as follows in *21 U.S.C. § 355*:

> the 180-day period ending on the day before the date on which an application submitted by an applicant other than a first applicant could become effective under this clause

#### Citation:
  - *21 U.S.C. § 355*
  - Heading: **CHAPTER 9-FEDERAL FOOD, DRUG, AND COSMETIC ACT > SUBCHAPTER V-DRUGS AND DEVICES > Part A-Drugs and Devices**

