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[email protected] Medical Prescription (Rx) Market Definitions Drug Product Terminology Small Molecule Drugs: Drugs with an active chemical ingredient that is not live, but chemically synthesized and typically are taken orally or topically, such as capsules, tablets, powders, ointments, and sprays. Brands: Also referred to “small molecule drugs,” brand drugs require original research and development for FDA licensure (also called “FDA approval”). They are approved (or licensed) under a New Drug Application (NDA). They are patent protected for 20 years total (which usually includes years clinical research before the drug is approved, or licensed). They are still referred to as brands even after the patent has expired (which distinguishes these drugs from generics). A brand can be ‘first in class” if it is a new chemical entity or new mechanism of action. It is a “me too drug” if it is not first in class. The definition of “me too” varies – different chemical composition, different mechanism of action. The drug is quite similar but different enough to get a patent. Generic: Small molecule products that are demonstrated to be clinically equivalent to a branded product (e.g., same active ingredient and route of administration, same mechanism of action). Generics do not require original research for FDA approval. Generics come to market only after the patent has expired on the brand product. Licensed under an Abbreviated New Drug Application (ANDA) by the FDA. Large Molecule Drugs: Commonly referred to as “biologics” and “biosimilars.” They contain live active ingredients and are generally infused or injected, and otherwise not taken orally or topically.