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What are generic drugs?
Generic drugs offer a therapeutic alternative to innovative drugs. They contain the same active ingredients as the original innovative products, and are available in the same strengths and dosage forms as the original.
Why are generic drugs’ names different from the original drugs' names?
Regulators demand that generic drugs be given a different name from the original drugs, in order to avoid confusion. Typically, the generic name of a drug is based on the name of its API, whereas the names given to original drugs are intended for marketing purposes.
Are generic drugs safe?
A generic drug is bioequivalent to the original innovative drug and meets the same quality standards. The active ingredient, the content, the dosage form and the usage of a generic drug are similar to those of an innovative drug. Generic drugs are essentially the same as the original drug, but are offered at a lower price.
What does Bioequivalence mean?
Bioequivalence demonstrates a similar profile of behavior of two products in the human body, in terms of the rate and extent of absorption of the active pharmaceutical ingredient from the gastrointestinal (GI) tract to the blood stream. Bioequivalence study is a regulatory requirement and is performed for all generic drugs to ensure their efficiency and the safety.
How do you ensure generic drug safety, having tried it in only a limited number of patients?
The generic product's active pharmaceutical ingredient (API) is identical to that of the innovative drug, its purity profile is similar and it is found to be bioequivalent; therefore its safety and efficacy are also comparable.
Why are generic drugs cheaper?
Generic companies are not required to perform lengthy and costly toxicological and clinical studies; therefore, they can offer their products to the public at considerably lower costs.
Does every drug have a generic equivalent?
As long as a drug is protected by patents, a generic alternative can't be launched. Sometimes a generic version is approved and available in a specific country or countries, while unavailable in others. However, with the growing emphasis on generics, multiple generic versions of an innovative drug are often developed around about the time it becomes "off patent". Nonetheless, in some instances, even after a patent has expired there is no generic alternative. This may happen due to cost considerations, in cases of drugs designed for a limited use or requiring complex manufacturing processes.
Does the generic drug look the same as its original equivalent?
Sometimes the generic version of a drug may have a different color or shape from its innovative original, but these changes do not affect the drug's attributes.