Generic Drugs : A Drug Product

1362 WordsMay 12, 20166 Pages
INTRODUCTION: A Generic drug (generics) is a drug product that is comparable to a brand/reference-listed drug product in dosage form, strength, quality and performance characteristics, and intended use. These are produced and distributed without patent protection. The Generic drug must contain the same active ingredients as the original formulation. Generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. Most of the generic products are available once the patent protections afforded to the original developer is expired, when it happens it often leads to substantially lower prices for both the original brand name product and the generic forms. Drug patents in US give twenty years of protection, but as they are applied for before clinical trials begin, the effective life of a drug patent tends to be between seven and twelve years.1 WHY GENERIC DRUGS ARE INTRODUCED The principal reason for the relatively low price of generic medicines is 1. When patents no longer protect Drugs, competition increases among producers, companies create generic drugs at less cost and are therefore able to maintain profitability at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford them. 2. Generic manufacturers don 't bring about the expense of medication disclosure and rather can reverse engineer known drug compounds to
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