Innovator and generics: Pharmaceutical Regulatory Science Notes
A generic drug
According to FDA, “A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics”.
An innovator drug
An innovator drug is the first drugs created containing its specific active ingredient to receive approval for use. It is usually the product for which efficacy, safety and quality have been fully established. When a new drug is first made, drug patent usually will be acquired by the founding company. Most drug patents are protected up to 20 years. During the patent period, other companies cannot make or sell the same drug until the patent expires.
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