Application Note SI-02269 Identification of a Pharmaceutical Tablet’s Origin Using FT-Near-IR and Principal Component Analysis

Introduction After 10–15 years and $800 million, a pharmaceutical company developed a new drug candidate that successfully passed all the Food & Drug Administration (FDA) mandated clinical trials and is now ready for sale to patients in the United States. There is a clear reason for the eagerness of drug companies to manufacture a generic version of its pioneer equivalent once it is no longer under patent protection; in 2006 Pfizer reported over $1.5 billion in sales of its Zyrtec® product, which was losing patent protection in September of that year. To protect the consumer, in 1984 the FDA passed the Waxman-Hatch Act that requires generic drugs to maintain the same bioequivalence and pharmaceutical equivalence as their pioneer counterpart, while the excipients can vary.