A generic version of a drug must, by law, have the same active ingredients as the original brand drug. … This is known as a single source generic, where the manufacturer has the sole right to produce the generic version of that drug for anywhere from six months to one year.
What is a multi-source generic drug?
A drug product manufactured by more than one company or source. Multi-source drugs are those that are available both as the brand-name drug, and as generic equivalents or generic alternatives.
An authorized generic is considered to be therapeutically equivalent to its brand-name drug because it is the same drug. This is true even if the brand-name drug is “single source,” meaning there are no ANDAs approved for that product, or coded as non-equivalent (e.g., BN) by FDA in the Orange Book.
