Pharmaceutical Lifecycle Extension Strategies - Innovation and Marketing in the Pharmaceutical Industry - page 228

Table 8.1 Overview of pharmaceutical terminology and abbreviations
Abbreviation Explanation

ANDA Abbreviated new drug application: contains data that provides for the

review and ultimate approval of a generic drug product. These are not
required to include preclinical (animal) and clinical (human) data to
establish safety and effectiveness. Instead, a generic applicant must
scientifi cally demonstrate that its product is bioequivalent.

Bioequivalence The absence of a signifi cant difference in the rate and extent to which the

active ingredient/moiety in pharmaceutical equivalents (i.e., same active
ingredient, dosage form, route of administration and strength) becomes
available at the site of drug action when administered at the same molar
dose under similar conditions in an appropriately designed study.

NDA New drug application: an application for a new drug approval containing

data from specifi c technical viewpoints for review, including chemistry,
pharmacology, medical, biopharmaceutics, and statistics. If the NDA is
approved, the product may be marketed.

NME New molecular entity: an active ingredient that has never before been

marketed in any form.

OTC Over-the-counter: drugs classifi ed as safe and effective for use by the

general public and which can be obtained without a doctor's
prescription.

sNDA Supplemental new drug application: an application to allow a fi rm to make

changes in a product that already has an approved NDA.

SPC Supplementary patent certifi cate: extension of a patent used by the

European Union.

and market approval can be substantial and shortens the patent-protected time of the
branded drug on the market. Regulatory bodies often compensate for the lost time,
as a result of clinical testing, by extending the patent or the market exclusivity
period. In Europe, for example, a supplementary protection certifi cate (SPC) can be
obtained extending the patent for a maximum of 5.5 years (Table 8.1 provides an
overview of pharmaceutical terminology and abbreviations used in this chapter).
I discuss the US regulations in more detail. In 1984, US congress passed the
Hatch-Waxman Act—also known as the Drug Price Competition and Patent Term
Restoration Act—which regulates the competition between branded and generic
drugs. It marks an important change in the US pharmaceutical market and applies to
all pharmaceuticals, except antibiotics, and biotechnology products. I discuss two
important parts of the Act. 6
Title I allows generic drug makers to fi le an abbreviated new drug application
(ANDA), which involves a bioequivalent of a branded drug whose patent expires.
Compared to before the Act, generic drug makers do not have to prove the safety
and effi cacy of the drug anymore, which involves substantial costs and creates high
barriers to entry. The Act required generic manufacturers to only show bioequiva-
lence of their drug.

6 See for the complete law: Public Law 98-417.