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What is a generic medicine?

Medicines will often have more than one name; a generic name, which is the active ingredient of the medicine, and a brand name, which is the trade name the manufacturer gives to the medicine.

  • Read our frequently asked questions about generic medicines
  • Are generic medicines as safe and effective as brand name medicines?

    The approval of a generic medicine means that it has been tested for bioequivalence, which ensures that the safety and efficacy standards of generic medicines are the same as brand name medicines.

    The manufacturing process of generic pharmaceuticals is strictly regulated according to standards which rank with the manufacturing process of original innovative products.

  • Does a generic medicine look the same as its brand name equivalent?
    Sometimes the generic version of a medicinal product may have a different color or shape from its brand name counterpart. These differences have no effect on the medical action of the chemical molecule. They are created simply to distinguish the appearance of one drug from another.
  • Does every brand name medicinal product have a generic medicine counterpart?

    No. If a generic version of a chemical molecule is not developed by anyone, even after expiration of the patent on an innovative medicinal product, the innovative product would still remain the only approved product available. Sometimes a generic version is approved and available in a specific country or countries, whilst in other countries the innovative product remains the only product on the market.

    However, with the growing emphasis on generics, it's rare that a generic version or more than one generic version of a chemical molecule is not developed around about the time that its innovative counterpart comes "off patent". The reason for not doing so may be, for example, a complex manufacturing process of a drug designed for a limited use, where the cost of developing and selling a generic version of the product would not be viable.

  • How does a innovator protect its product?
    When a developer of a new chemical molecule believes it has a useful product, it may decide to apply for a patent, which if granted, will typically last for twenty years, depending on the jurisdiction in which its issued. This means that, among other rights, that the developer - the originator of the chemical molecule - has the sole right to obtain regulatory approval of, manufacture and market the medicine, or license others to do so, during the life of the patent. Also, the brand name of an innovative medicine is often protected as a trade mark and cannot be used by any other party. Developers often secure additional and ancillary patents after the initial patent is issued, in order to prolong their period of exclusivity.
  • What are generic medicines?
    Generic medicines use the same active ingredients as the original brand name products, and are generally available in the same strengths and dosage forms as the original. A generic medicinal product must be bioequivalent to the original brand name product and meet the same quality standards as the innovative product.
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For further information on generic drugs visit the British Generic Manufacturers Association (BGMA) website.

References:

[1] BGMA website