A drug when manufactured and distributed without the copyright safeguards is called a generic drug and the concerned procedure is called the generic drug development. A copyright may prevail on the constitution but not on the active constituent.
The active constituents in the generic drug must not be dissimilar than the original formulation.
Drugs that are manufactured generically are alike or equivalent in biological properties to the brand name counterpart with respect to pharmacokinetic features as stated by the U.S. Food and Drug Administration (FDA).
By extension, generics are equivalent in dosage, path of dispensation, strength, efficacy, safety, and the type of use intended. In most cases, the availability of generic products depends upon the expiry of the patent safeguards provided to the original manufacturer.
The prices for both the original brand name product and the generic forms are reduced significantly when generic products become accessible due to the competition prevalent in the market. The time a generic product takes to appear in the market is usually variable. Twenty years of protection is given by the drug patents in the US. The actual life of a drug patent is usually in between six and thirteen years.
Posted on January 17th, 2009 by admin
Filed under: Health
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