GLOSSARY
Applicant holder
The applicant holder is the name of the company who holds the FDA's approval to supply a medication at a specific dosage in the US.
FDA
The U.S. Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
Generics
Once a patent or exclusivity agreement has expired other companies can be approved by the FDA to supply a “generic version” of the medicine. These medicines are called “generics” and they have identical active ingredient/s, dosage forms, routes of administration and strengths to patented products.
Orange Book
The FDA's Orange Book aggregates information on approved medicine products and therapeutic equivalence evaluations, in the USA. This was the main source of information for Stage I of E$$ENTIAL MEDICINE$.
Patent & exclusivity agreement
When first approved, many new medicine products are protected under a patent or an exclusivity agreement allowing the applicant holder to exclusively supply that product for a number of years
Trade name
Also known as the proprietary name or brand name. This is the name given to a medication registered by its owner at a specific dosage, as a trademark.