Brand-name vs generic

What has to match between a brand-name and a generic drug?

FDA requires an approved generic to contain the same active ingredient as the brand-name, or innovator, drug, at the same strength, in the same dosage form, such as a tablet or an injectable, and given by the same route of administration, such as oral or topical [1]. FDA states that approved generic medicines "work in the same way and provide the same clinical benefit and risks" as their brand-name counterparts [1]. A generic drug that meets FDA's scientific standards can generally receive final approval once the brand drug's patents and marketing exclusivities expire, or if those patents are successfully challenged [1].

How is a compounded drug different from a generic?

A generic drug goes through FDA's approval process and must establish therapeutic equivalence to the brand-name drug before reaching patients [2]. A compounded drug, prepared by a pharmacy for an individual patient, is not approved by FDA through that process [2]. That difference matters for GLP-1 medications: see compounded semaglutide and wegovy generic name for how it applies to specific drugs.