Generic Drugs

As per the Office of Generic Drugs (OGD) of the U.S. Food and Drug Association, a generic drug is “identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.” To provide protection for the person or entity that incurred the initial expense (including research, development, and marketing expenses) to develop the new drug, brand name drugs are generally given patent protection for[Page 224] 20 years from the date of submission of the patent. When the patent expires, other drug companies can introduce competitive generic versions, which have to be thoroughly tested by the manufacturer and approved by the FDA before release.

Patents granted after June 8, 1995, now have a 20-year patent life from the date of the first filing of the patent application. Before June 8, 1995, patents were granted for 17 years. However, the effective patent term is frequently less than 20 years, because patents are often obtained before products are actually marketed. Many factors influence the length of the effective patent term, including the requirements in the federal Food, Drug, and Cosmetic Act and in the Public Health Service Act that certain products receive FDA approval before marketing. Before the FDA will approve the product for marketing, new drug products for humans generally must undergo extensive testing in both animals and humans to show that the drugs are both safe and effective. Consequently, to stimulate product development and innovation, Congress in 1984 enacted Title II of the Drug Price Competition and Patent Term Restoration Act (Public Law 98–417) to extend patent life to compensate patent holders for marketing time lost while developing the product and awaiting government approval. A maximum of 5 years can be restored to the patent. In all cases, the total patent life for the product with the patent extension cannot exceed 14 years from the product's approval date, or in other words, 14 years of potential marketing time. If the patent life of the product after approval is 14 or more years, the product would not be eligible for patent extension. To get an extension, the application for patent extension must be filed within 60 days of FDA approval of the drug product, even if the product cannot be commercially marketed at that time.

Just as there is a process to approve new branded drugs on the marketplace, the FDA also has a rigorous approval process for generic drugs. The application process for generic drugs is much more abbreviated, because preclinical data from animal studies or preliminary human data are not required (this was already provided by the branded medication and would only be redundant). Instead, the principle of bioequivalence is used by measuring the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives the rate of absorption, or bioavailability, of the generic drug, which can then be compared with that of the branded drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.

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