Innovator Drug
What is an innovator drug?
An innovator drug is the first drug of its kind to contain a specific active ingredient that has not been used in any other drug, making it a new chemical entity (NCE). Due to its novel nature, an innovator drug undergoes extensive testing to demonstrate its efficacy, safety, and quality before receiving approval from regulatory agencies like the FDA.
Companies that develop innovator drugs are granted a period of market exclusivity, which prevents other manufacturers from producing generic versions of the drug during this time. The duration of exclusivity varies depending on factors such as the drug’s classification, the submission process, and the clinical trials conducted. Small molecules typically receive a shorter period of exclusivity, while biologics, due to their complexity, may benefit from a longer period of exclusivity. Once this period ends, other companies can apply to make and sell generic versions of the drug.
How do innovator drugs improve healthcare?
Innovator drugs introduce new active ingredients and novel mechanisms of action, leading to new treatment options for patients. Each innovator drug can potentially open new avenues for the treatment, prevention, or management of medical conditions, thereby advancing healthcare.
The development of innovator drugs involves substantial investments in research and development. The exclusivity period helps companies recover these costs by providing a competitive edge and protecting the market for their new drug during the initial years after its launch.