Generic drugs

What are they

Generic medicines, also called equivalents, are medicines that contain the same active ingredient as proprietary medicinal products.

The first and most obvious difference concerns the name: generics are sold with the name of the active ingredient, while “brand” ones are marketed under an invented name (the registered trademark).

To avoid confusion between possible synonyms, the International Common Name (INN) is used, in practice a contraction of the chemical name that is usually too long, followed by the name of the manufacturer.

What are they?

The molecules that can be purchased in pharmacies as equivalent drugs are those whose patent has expired.

As long as a medicine is covered by a patent, in fact, the only company that can market it is the one that discovered it and then registered it.

In Italy and throughout Europe the patent coverage lasts 20 years, extendable for another 5 years with the SPC (Supplementary Protection Certificate).

What categories of drugs does it cover

The generic drug can be either over-the-counter, or OTC, that is, freely purchased without a doctor’s prescription, or prescribed, therefore purchased only with a medical prescription.

An equivalent medicinal product shall be subject to the same system of dispensing to the general public as the medicinal product from which it is derived.

Registration

In order to be sold in pharmacies, a generic drug must be a faithful “copy” of the registered medicinal product.

In practice, it must contain the same active ingredient, at the same dose, it must be formulated in the same pharmaceutical form, it must provide the same route of administration and the same therapeutic indications.

The characteristics required at the time of registration, to obtain the marketing authorization (MA) therefore concern only the so-called bioequivalence tests to the drug that is intended to be duplicated.

Bioequivalence means that the two medicines, the generic and the “branded”, once taken must demonstrate exactly the same behavior in both qualitative and quantitative terms.