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| GLOSSARY
ANDA, Abbreviated New Drug Application, is the process of obtaining approval to market a generic drug. An ANDA contains information demonstrating that the generic drug is bioequivalent to the brand-name product and certification that the generic drug does not infringe on any patent for the brand-name product listed in the Orange Book or certification that the listed patents are invalid. Bioequivalence is the Food & Drug Administration requirement that the active ingredient of a generic drug be absorbed into the body and metabolized in approximately the same amount over approximately the same period as the active ingredient of the innovator drug. Bio-equivalence is demonstrated in two ways. Dissolution testing determines if the generic drug product dissolves in approximately the same amount of time as the innovator product. Blood-level testing is done by giving the generic drug product to humans and measuring how much of the drug enters the bloodstream, how fast it does so, and how long it takes to leave the body. Generic drug (multisource pharmaceutical) is a pharmaceutical preparation that is essentially similar to an original product, involves an active ingredient that is no longer protected by patent, is approved for sale by a simplified registration, and is sold under a common name with little, if any, promotion. NDA, New Drug Application, is the process of obtaining approval from FDA to market a new drug. 180-day exclusivity is the marketing exclusivity granted to the first applicant that files an ANDA with Paragraph IV certification. Orange Book is the common name of "Approved Drug Products with Therapeutic Equivalence Evaluations," the FDA publication that lists, among others, patents protecting the active ingredient, formulation, and method of use of a drug product. Paragraph IV certification is a declaration that a patent listed in the Orange Book is invalid or will not be infringed by the generic drug in an ANDA. 30-month stay is the automatic prohibition of FDA action on an ANDA with a Paragraph IV certification if the brand-name company files a patent infringement suit against the generic applicant within 45 days.
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