The global generic drugs market has been forecast to hit an estimated value of $127.8 billion by the end of 2013, driven by a number of key factors, including the expansion of healthcare coverage and a rising demand for prescription drugs.
A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use."
Although they may not be associated with a particular company, generic drugs are subject to the regulations of the governments of countries where they are dispensed. Generic drugs are labelled with the name of the manufacturer and the adopted name (nonproprietary name) of the drug.
A generic drug must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties.
By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use.
Last year, more than 40 brand-name drugs -- valued at $35 billion in annual sales -- lost their patent protection, meaning that generic companies were permitted to make their own lower-priced versions of well-known drugs like Plavix, Lexapro and Seroquel -- and share in the profits that had exclusively belonged to the brands.
In 2013, the value of generic drugs scheduled to lose their patents and be sold as generics is expected to decline by more than half, to about $17 billion. Meaning the patent cliff is over, which is great for large pharma, but that also means the opportunities theoretically have dried up for generics.
Generic companies could gain an edge by expanding into global markets. While use of generic medicines is widespread in the United States -- an estimated 80% of prescriptions are filled with generics -- they are less popular in places like Europe and Japan, although that is changing.
For more information on the global generic drugs market, see the latest research: Global Generic Drugs Market
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