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Abbreviated New Drug Application (ANDA)

An application submitted to the FDA for approval of a generic drug. It typically relies on the FDA's findings of safety and effectiveness for a previously approved brand-name drug.

Federal Food, Drug, and Cosmetic Act

The main federal law governing the safety of food, drugs, medical devices, and cosmetics. This bill proposes amendments to this act.

Patent

A legal right granted to an inventor or owner that gives them exclusive control over making, using, or selling an invention for a set period, preventing others from doing so without permission.

30-month period

A specific legal delay (or 'stay') of up to 30 months in the FDA's approval of a generic drug, typically triggered when a brand-name drug company files a patent infringement lawsuit against a generic drug applicant.

Covered patent

Under this bill, for new drugs, it's the single patent chosen by the brand-name drug company that is eligible to trigger the 30-month delay in generic drug approval if a lawsuit is filed.

Evergreening

A practice by brand-name drug companies to extend their monopoly on a drug, often by obtaining new patents on minor changes to an existing drug, thereby delaying the entry of generic competition.