People often use the word “generic”, while regulators usually refer to an equivalent or generic medicine. An authorised generic must meet defined quality standards and demonstrate that it delivers the active ingredient in a way that is comparable with the reference medicine.
What must be the same?
An authorised generic contains the same active ingredient and is used at the same dose for the same condition as its reference medicine. It must meet the same standards for quality, manufacturing and safety. Bioequivalence studies are used to confirm that exposure to the active ingredient falls within an accepted range.
What may be different?
- the product name and manufacturer;
- colour, shape and packaging;
- some inactive ingredients;
- price.
Inactive ingredients do not change the active substance, but they can matter for people with an allergy or intolerance. Always check the patient leaflet and ask a pharmacist if you are unsure.
Why are generic medicines often less expensive?
After patent protection for the reference medicine expires, other manufacturers can apply for authorisation without repeating the entire original development programme. A lower price therefore does not, by itself, indicate lower quality.
Authorised generic does not mean unverified product
The term generic applies to medicines assessed by the relevant authorities. A product from an unclear source, with incomplete labelling or unverifiable packaging, is not automatically a legitimate generic simply because it claims to contain the same ingredient.
How to choose
Availability, price, inactive ingredients and personal preference may all influence the choice. If you use prescription medicine or have other health conditions, discuss any substitution with a doctor or pharmacist.
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