Frequently asked questions about generic medicines

Branded or innovative medicines are new medicines. A new medicine often comes about through the research and development of a new chemical molecule. The developer of that molecule will get regulatory approval for the medicine and a patent to protect their invention. They’ll then produce and sell it, or give permission for others to do so. They will also apply for sole exclusive rights to protect it which, if granted, last for about fifteen years. 

When a company develops a new medicine, it is known both by its generic name – the name of the active or key ingredient – and by its brand name, which is the name which the developer sells the medicine under. The brand name is chosen by the developer and is usually something that’s easy for patients and healthcare professionals to recognise and pronounce, it will start with a capital letter and the generic name will be a more scientific sounding name which won’t start with a capital letter.

Generic medicines use the same active or key ingredients as the original brand name products, and are generally available in the same strengths and dosage forms as the original. They also have to be the same as the branded version in terms of quality.

Yes, if a generic medicine is going to be approved for use it has to be, for all intents and purposes, as safe and as effective as the brand equivalent.

To determine this, each medicine is tested for bioequivalence. This test has to prove that if the generic medicine and the branded medicine were given in the same dose, in the same way, meeting the same standards, their effects could be expected to be the same. 

When generic medicines are manufactured, they have to meet the same strict regulatory standards as when brand name medicines are produced.

Sometimes the generic version of a medicine may have a different colour or shape from its brand name equivalent. These differences have no effect on the way the chemical parts of the medicine work.

When the developer of a new chemical molecule believes it has produced a useful medicine, it will probably decide to apply for sole exclusive rights, which, if granted, will last for about fifteen years (developers can then apply for extensions to their period of exclusivity). During the time when they have exclusive rights they will get regulatory approval for the medicine. Then they will produce and sell it, or give permission for others to do so. Also, the brand name of an original medicine is often protected as a trade mark and cannot be used by anyone else.

All pharmaceutical companies have to follow strict quality control procedures and standards when producing medicines whether they are making innovative or generic medicines. They are also regularly inspected by regulatory health authorities. 

Many pharmaceutical companies that make innovative medicines also make generic medicines and the manufacturing approval process is complex for both types.

When the exclusive rights on an innovative medicine run out, the medicine may be produced and sold by other companies under a different brand name, or under its generic name, once regulatory approval is obtained. In order to manufacture and market the generic medicine companies must stay within the regulatory health authority guidelines which apply in the countries where the medicine is going to be produced and sold.

In order for a generic medicine to be approved for use by the regulatory authority, the company has to prove that, for all intents and purposes, it is as safe and as effective as the brand equivalent. To determine this, each medicine is tested for bioequivalence. This means that if the generic medicine and the branded medicine were to be given in the same dose, in the same way, meeting the same standards, their effects could be expected to be the same. 

The tests which are carried out are very detailed, for example as well as having the same key ingredient the way and speed at which that ingredient gets into the body’s bloodstream must also be comparable in the generic medicine as it is in the branded version.

No two companies are exactly the same. Differences between companies can be seen in their manufacturing, research and development processes. Companies can be large or small in size, have many or very few years of experience, and offer a large or small variety of medications. All drug manufacturers must follow the same standards and regulations. 

Teva is the largest manufacturer of generic drugs in the world. With more than 110 years of experience, Teva is committed not only to meeting each country’s regulatory and quality standards, but to exceeding them, and providing affordable and quality medications.  Some patients feel more comfortable choosing a generic by a company they trust.

As the largest generic manufacturer in the world, Teva has a global network of manufacturing and distribution facilities.

The regulatory body in the US, the Food and Drug Administration (FDA), and the European regulatory body, the European Medicines Agency (EMA) and other major regulatory authorities inspect each of our facilities to ensure our products meet the same high standards of good manufacturing practices as brand-name medications.

Prescribing and dispensing generic medicines saves the NHS money, that's the bottom line.

It takes a lot less time and money to develop a generic medicine than it does to develop an innovative medicine, so generic manufacturers can afford to sell their medicines for a lower price than those who sell equivalent branded medicines.

• The generic medicines industry helps save the NHS over £13 billion per annum. 01
• The average cost to the NHS of a generic medicine is £4.03, the average cost of a branded medicine is around £20.73. 02 
• In fact, without generic medicines, the NHS medicines bill would be approximately twice as much as it is now. 03

By dispensing more generic medicines, it allows more patients to be treated with the same medicine for the same cost; it means that with those savings the budget can be used to pay for innovative products and services that help patients; and the NHS can use the savings else where, such as supporting other essential services, or employing more doctors and nurses.

Competition from companies who produce generic medicines also encourages researchers within the pharmaceutical industry to develop new medicines.