The Next “Big Thing”

 The next “Big Thing” for pharmaceutical companies competing generic products for its blockbuster brand products is the ability to circumvent the issue through novelty or improved products. Evidently, the presence of the generic alternative substantially reduces a brand-name product’s revenue but presents affordable choices for consumers. In the US, the “drug price competition and patent term restoration Act”, popularly known as the “Hatch-Waxman Act” of 1984 allows the introduction of a generic version of a brand-name product under an abbreviated new drug application (ANDA) criterion (Whitmore, 2004). The USFDA’s ANDA only requires pharmacokinetics, pharmacodynamics and bioequivalence information in other to consider a generic version for approval. The regulatory processes for the generic introduction of small molecules in the market have always been an attractive business to generic companies. One primary reason for its attractiveness is the enormous saving for introducing a generic product in the market over the introduction of

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