Generics FAQs

A generic medicine contains the same active medicinal substance as an originator pharmaceutical product. Because it acts in the same way in the human body, it is interchangeable with the originator product. Generic medicines are launched when the originator product's patent has expired.

Generic medicines contain the same active ingredients as originator pharmaceuticals and act in the same way on patients. Equivalent generic medicines may contain different non-active ingredients (such as colourings, starches, sugars, etc.) and they may differ in size, colour or shape, but none of these have any impact on the therapeutic effect, i.e. the way they work in the patient's body.

Yes. Generic medicines must comply with exactly the same standards of quality, safety and efficacy as all medicinal products. They are produced in inspected plants under what is known as Good Manufacturing Practice (GMP). And, just like originator products, once a generic medicine is sold on the market, it must be monitored by the manufacturer in case any adverse reactions are reported.

Yes, and the savings are significant. Generic medicines cost 20% to 90% less than the original price of their brand-name equivalents. In addition, competition from rival generic products forces originators to reduce their own prices after – or sometimes before – patent expiry.

As in other industries, the standard patent is 20 years. But, uniquely for pharmaceuticals and plant technologies, this can be extended by up to a further five years by gaining a supplementary protection certificate (SPC).

Yes. Pharmaceutical products are covered by a number of patents, sometimes as many as 30 to 40. In addition, a patent on a new use ('indication'), formulation, salt or ester can block the registration or marketing of a generic medicine for treatments where the base patent has already expired. This is a strategy known as 'evergreening', which aims to prevent or delay competition from generic medicines by extending market protection through patents on minor changes to the original product.

Data exclusivity is a separate and additional provision to patent protection for the originator medicine. It defines a period of time during which the generic applicant is restricted from applying for market authorisation. Consequently, generic medicines can only be evaluated and approved by medicines authorities after the data exclusivity period has expired, except in the rare case that unusual and much more expensive procedures are followed.

No. Generic medicines applications do not make use of any data from the originator registration file. In fact, the data of originator products are never revealed to third parties, and so cannot be used by generic medicines researchers. Instead, generic medicines producers research and develop their own formulation of the product, which must then be approved under the same requirements as the originals.

Since generic medicinal products contain well-known, safe and effective substances, the pre-clinical tests and clinical trials performed by the originator are not repeated. Indeed, it would be unethical and contrary to international convention to do so. The safety and efficacy of a generic product are cross-referenced with the originator product's dossier by the medicines authorities, who alone have access to these files.