New drugs are protected
Newly introduced drugs are usually protected by patent. Another company is not allowed to copy these drugs and distribute them themselves without the manufacturer’s consent. However, this protection expires after a few years. For example, the antidepressant escitalopram (Cipralex) was approved in many countries in 2001 and the patent protection was revoked in 2014. Patent protection granted by law is generally 20 years in many countries. With a supplementary protection certificate, the patent term can be extended by five years. This is because patents are filed much earlier during drug development rather than at launch, which shortens the effective useful life.
Generics – successor drugs
Generics (singular: generic drug) are successor drugs that enter the market after patent protection has expired. They contain the same active pharmaceutical ingredients as the original drug in the same quantity and dosage form. However, they may differ in terms of excipients, appearance and packaging. However, generics are often designed to be very similar to the original in order to increase patient acceptance. For example, some Viagra generics contain the dye indigocarmine and are colored blue like the original. A special case is represented by the so-called auto-generics, which are exactly the same as the original.
| Identical | Different |
| Active ingredient(s) | Excipients |
| Amount of active ingredient | Appearance |
| Presentation | Name |
| Bioavailability1 | Packaging |
1 within defined limits
Price advantage
The development costs for a new drug today are estimated at well over one billion Swiss francs. A generic drug can be offered at a much lower price than the original drug because this enormous financial outlay is eliminated. For example, a pack of the lipid-lowering drug Sortis (20 mg, 100 tablets) cost over CHF 200 before the introduction of generics. The corresponding atorvastatin generics went on sale for about CHF 70. Prescribing and dispensing generics therefore greatly relieves the burden on healthcare systems and premium payers.
Do generics and originator drugs correspond?
For patients, the crucial question is whether the efficacy of the generic drug matches that of the original and whether there are no additional adverse effects. Is the “copy” as good as the original? It is not only important that the same active ingredient is contained in the same dose in one tablet. It is equally important that the active ingredient reaches the body from the digestive tract to the same extent and at the same speed as the original. Every generic product must pass this bioequivalence test before it is approved and must meet defined limits. With regard to drug quality, no distinction is made between original and generic drugs.
Generic Substitution
As a rule, the replacement of an original drug with a generic drug can be done without any problems. Caution is indicated especially for drugs with a narrow therapeutic range, for example, antiepileptic drugs (e.g., carbamazepine), antiarrhythmic drugs (e.g., amiodarone), and some psychotropic drugs (e.g., clozapine). Drugs that require individual therapy adjustment (e.g., lithium) can also be problematic. Therefore, substitution of prescription medications should be discussed with a medical or pharmaceutical professional. These are familiar with critical medications.
