Table 2.
Market Exclusivity Awarded by the Generating Antibiotic Incentives Now (GAIN) Act
| Characteristic | Previously Awarded Exclusivity Period (Years) | New Exclusivity Period With the GAIN Act |
|---|---|---|
| Previously approved drug with a new indication | 3 | 8 y |
| New active ingredient | 4–5 | 9–10 y |
| Rare-disease (orphan) drug | 7 | 12 y |
| Companion diagnostic test | Not applicable | 6 additional monthsa |
Abbreviation: GAIN, Generating Antibiotic Incentives Now.
a
Companion diagnostic tests are those that aid in the diagnosis of a qualifying pathogen and act hand in hand with the qualified infectious disease product to give 6 additional months beyond the new exclusivity period.