What Is a Single Source Generic

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.

Are authorized generics better?

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.

Sarah Jenkins

Sarah Jenkins

Senior Technology Editor & AI Specialist

Sarah Jenkins is a veteran tech journalist with over 12 years of experience covering artificial intelligence, mobile innovations, and digital ethics. Her insights have appeared in leading technology publications worldwide.

Share this article
Twitter Facebook Pinterest