What are generics?

Generic is a drug that copies the original – the one that was first invented. If a company has registered a drug with a new molecule or a combination of molecules and received a patent, then for some time it may use the exclusive right to produce the medicine. Usually, this period lasts for 20 years from the date of the patent receipt. After that, other companies also get the right to sell this medicine. Such analogs are called “generics”.

How are generics different from original drugs? What’s better?

Theoretically, there should not be significant differences in efficiency and safety – because the manufacturers of generics use the same active substance. Practically, generics can affect the body in a different way. In fact, only original drugs with a 100% probability give the claimed effect.

This happens because drugs do not consist of only the active substance. Pharmaceutical companies use various excipients that are responsible for the form, allow the active component to be released at the right speed and in the right place.

Generics enter the market after a rather long time of original version adaptation. As a rule, the process of the active ingredient synthesis has been studied quite well. But the task of selecting excipients to create a generic is not always simple.

If excipients are chosen in the wrong way, this can seriously affect the effectiveness. For example, auxiliary ingredients are especially important for long-acting drugs. Slight fluctuations in their quality can result in a radically different dynamics of the drug release in the human body. As a result, there may appear an overdose or lack of effect. In addition, raw materials for generics are sometimes purchased from different suppliers. These substances may contain different impurities. Production conditions, too, happen to be significantly different.

Why are generics cheaper than original drugs?

In most cases, generics are cheaper because their manufacturers do not invest in finding new effective and safe molecules. Those involved in such research need to somehow cover the costs of not only the development of new drugs but also for research that ends in failure. Therefore, often the original drugs are expensive, and their monopoly lasts a long time.

Often the price of the original drugs really seems too high. Various public health authorities and activists are trying to fight it. Unfortunately, not always successful.

Why do generics have such a different price?

There may be several reasons. First of all, this is largely influenced by market conditions. There is no direct correlation between cost and quality. There can be strange situations when a generic is more expensive than the original drug. The cost of generics can also be affected by the cost of components. Excipients can also be of varying quality and, respectively, cost.

How much can a normal generic cost?

It is difficult to specify any minimum cost, but very cheap options raise serious suspicions. If the original drug costs $100, and the generic one costs $2, the question arises why it is so cheap. The rate includes not only the drug itself, but also the work of the specialists who developed this drug, tested it, and all these episodes of quality control during production, its research. They also need to pay a salary. And often, savings are achieved not only due to the substance but also due to quality control. FDA is the minimum requirement. If your pharmaceutical company is FDA-certified, it seriously increases the level of trust in it.”

How to recognize a generic?

There are no official rules to recognize generics. There was no need for developing such a service because generics are a complete replacement for the original drugs. Everyone who is interested can refer to the list, where the original preparations with popular active ingredients are indicated.

Are generics legal? Are companies not trying to prevent generics from entering the market?

The production of generics is legal. Patents for medications are different from protecting other technologies. Therefore, patent validity is limited. Its validity differs in different countries, but in most cases is equal to 20 years. In the USA and the European Union in some cases, the patent validity can be extended for another five years. While the patent is valid, manufacturers in the absence of competition sell the original medication at a high price in order to offset the costs of its development and make a profit.

Pharmaceutical companies that invest billions of dollars in the development of new drugs are unsatisfied with the limited patent term. They apply various tricks to extend the protection of their intellectual property – from obtaining a new patent, slightly changing the drug composition. But even when such tricks work, they only allow you to delay the start of production of generics, but not to prevent it.