Generic alternatives to brand-name prescription medications are emerging as a dominant force in the global drug market as an increasing number of prescription drugs lose patent protection. In the United States, approximately 110 drugs will go off-patent between 2007 and 2010, creating opportunities for generic drug manufacturers to bring less expensive pharmaceutical equivalents to market.1
The availability of generic drugs provides advantages to consumers because of the cost savings over brand-name equivalents, resulting in increased accessibility to prescription drugs and increased compliance with drug regimens.2,3
Likewise, the importance of generics to the pharmaceutical industry continues to grow: In the U.S., generics comprised 63% of all prescriptions dispensed in the 12 months ending June 2007, representing an increase of approximately 16% since 2001.1
Understanding generics
(C SQUARED STUDIOS, CARTESIA, GETTY IMAGES ILLUSTRATION: PAUL A. BELCI)
Generic, non-systemically absorbed products (e.g., dermal, otic, ophthalmic, intranasal, and inhalation products) are typically approved for marketing after their therapeutic equivalence is demonstrated in clinical trials, where the efficacy of the generic and marketed product is compared. In contrast, pharma companies planning to market systemically absorbed, generic, solid, oral, immediate-release products (e.g., tablets and capsules) are not required to perform efficacy trials to support regulatory approval of their product because the safety and effectiveness of the active ingredient have been previously established.
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