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Orphan Drug

A drug developed to treat a rare disease or condition, which affects a small percentage of the population (typically fewer than 200,000 people in the U.S.).

Exclusivity Period

A period of time granted by the FDA during which a drug manufacturer has the sole right to market its approved drug, preventing generic versions from being sold.

Generic Drug

A medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use, but usually sold at a lower cost.

Rare Disease or Condition

A health problem that affects a small number of people, specifically defined in the U.S. as a condition affecting fewer than 200,000 individuals in the country.

COVID-19 emergency period

A specific timeframe, beginning December 1, 2019, and ending shortly before the official end of the broader public health emergency related to COVID-19, used to determine if a drug qualifies for this bill's provisions.

Investigational New Drug Application (IND)

A submission to the FDA that allows a drug to be tested in humans before it can be sold to the public.