| As the U.S. Food and Drug administration (FDA) has put it, to get FDA approval, a generic medicine must: contain the same active ingredients as the trade name drug (inactive ingredients may vary), be bioequivalent in efficacy, dosage form and route of administration; satisfy the same batch requirements for identity, effectiveness, purity and quality; be made under the same fixed standards of FDA's Good Manufacturing Practice regulations required for innovator medicines. In other words, their pharmacological effects are exactly the same as those of their trade name counterparts.
Although generic medicines are chemically bioequivalent to their brand name counterparts, they are commonly sold at substantial discounts from the trade name cost. It is estimated that generic medicines save consumers $8 - &10 billion yearly at retail drugstores. Even more billions are saved when hospitals use generic drugs.
The key reason for the comparatively low cost of generic medications is that competition escalates among manufacturers when drugs no longer are protected by patents. Companies incur fewer costs in creating a generic drug, and are, therefore, able to sustain profitability at a lower cost to consumers. The costs of these generics are so low that many developing countries can easily afford them. For instance, Thailand is going to import millions of doses of the generic version of Plavix, a blood-thinning medicine to preclude heart attacks, at a price of 3 US cents per dose from India, the leading producer of generic drugs.
Manufacturers of generic medicines do not incur the cost of drug discovery, and instead are able to reverse engineer known medication compounds to allow them to make bioequivalent versions. Firms do not bear the burden of proving the safety and potency of the medicines through clinical trials, because these tests have already been conducted by the branded company.
Sometimes, generic versions of a medication have different colors, flavors, or combinations of inactive ingredients comparing to trade name medications. According to the U.S. Trademark regulations, generic drugs are not allowed to look exactly like trade name drugs. Nonetheless, active ingredients in both preparations must be identical, ensuring that both have the same pharmacological properties. |