Frequently asked questions about generic medicines
Many of our medicines are what’s called a ‘generic’, and this might be the first time you’ve come across a generic Teva medicine. You can be sure generic medicines contain the same active, or key, ingredient(s) as the original medicine brand.
What are generic medicines?
A generic medicine is a medicine that is an equivalent substitute to a brand name medicine.
Generic medicines contain the same active ingredients as the original brand products, and are available in the same strengths and dosage forms as the originals.
A generic medicine must work the same way in your body and produce the same treatment result as the brand name medicine.
Why are generic medicine names different from the original medicine names?
All brand-name medicines have a generic name. The generic name often appears next to the brand name and is the active ingredient(s) in the medication. Regulators often require that generic medicines are given a different name than the brand-name medicines, in order to avoid confusion.
Typically, the generic name of a medicine is based on the name of its active ingredient(s), whereas the names given to brand-name medicines are intended for marketing purposes.
There are a few unique cases where the generic medicine may also have another name besides the active ingredient. Ask your pharmacist if you have any questions.
Are generic medicines safe?
A generic medicine is bioequivalent to the brand-name innovative medicine and meets the same quality standards. The active ingredient, the content, the dosage form and the usage of a generic medicine are similar to those of an innovative medicine.
Regulatory authorities review the safety of both brand and generic prescription medicine before they are approved for use in a country. They also continue to monitor safety of these medications after approval.
What does bioequivalence mean?
Bioequivalence demonstrates a similar profile of behavior of two products in the human body, in terms of the rate and extent of absorption of the active pharmaceutical ingredient from the gastrointestinal (GI) tract to the blood stream.
Bioequivalence study is a regulatory requirement and is performed for all generic medicines to ensure their efficiency and safety.
Why are generic medicines cheaper?
Generic companies can offer their products to the public at considerably lower costs than brand-name medicines because generic manufacturers do not;
- develop a medicine from scratch;
- perform lengthy, costly toxicological and clinical studies that brand manufacturers have already done;
- conduct expensive advertising and marketing programs.
Often, approvals will be granted to multiple generic medicine companies to manufacture generic equivalents which increase the competition in the market, thus driving the cost down.
Of course, we still must show the regulatory authorities that our product performs the same as the brand-name medicine.
Generic manufacturers do not set the price at the pharmacy so prices can vary between pharmacies. Ask your pharmacist if you have any questions.
Does every medicine have a generic equivalent?
As long as a medicine is protected by patents, a generic alternative can't be launched.
Sometimes a generic version is approved and available in a specific country or countries, while unavailable in others. However, with the growing emphasis on generics, multiple generic versions of a brand-name drug are often developed around about the time it becomes "off patent".
Nonetheless, in some instances, even after a patent has expired there is no generic alternative. This may happen due to cost considerations, in cases of drugs designed for a limited use or requiring complex manufacturing processes.
Will a generic medicine look the same as its brand-name equivalent?
Sometimes the generic version of a medicine may have a different color or shape from its innovative original, but these changes do not affect the drug's attributes. That’s because the appearance of a brand-name drug may be trademarked by the original manufacturer, so the generic product might be required to be a different shape or color. But, the active or key ingredients must be the same.
Are all generic medicine manufacturers the same?
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.
Where are Teva products made?
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.
What is generic substitution in Ireland?
The Government is implementing a law to allow pharmacists to substitute different versions of some prescribed medicines. Previously, if a brand name medicine was prescribed for you, the pharmacist had to dispense this brand. Under the new law, the pharmacist may substitute the medicine for a safe and less expensive alternative.
This law is being introduced, one medicine at a time, over the coming months and beyond.
The different version, often a generic medicine, is only offered to you if it does the same job as the one on your prescription, and if it has been included on an Interchangeable List published by the Irish Medicines Board. This law will save money for people paying for medicines, and for the taxpayer. 01
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Health Service Executive https://www.hse.ie/eng/health/hl/generics/ - Accessed December 2020.