We’ve provided these commonly asked questions about generic medicines to help provide the answers you want to know.
What are generic medicines?
Generic medicines offer a therapeutic alternative to innovative medicines. They contain the same active ingredients as the original innovative products, and are available in the same strengths and dosage forms as the original.
Why are generic medicine names different from the original medicine names?
All original medicines have a generic name. This name often appears next to the brand name and is the active pharmaceutical ingredient(s) (API) in the medication. Regulators require that generic medicines are given a different name than the original medicines, in order to avoid confusion. Typically, the generic name of a medicine is based on the name of its API, whereas the names given to original 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. If in doubt, ask your pharmacist.
Are generic medicines safe?
A generic medicine is bioequivalent to the original 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 medicines 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, for example. Bioequivalence study is a regulatory requirement and is performed for all generic medicines to ensure their efficiency and safety.
How do you ensure generic medicine safety, having tried it in only a limited number of patients?
The generic product's active pharmaceutical ingredient (API) is identical to that of the innovative medicine, its purity profile is similar and it is found to be bioequivalent; therefore its safety and efficacy are also comparable.
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:
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. You can contact your pharmacy to inquire about the cost of your medication, and be sure to tell your pharmacist if you prefer a Teva medicine.
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 an innovative medicine 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 medicines designed for a limited use or requiring complex manufacturing processes.
Does the generic medicine look the same as its original 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 medicine's attributes. That’s because the appearance of a brand-name medicine is trademarked by the original manufacturer, so the generic product might have to be a different shape or color. But, the active or key ingredients must be the same.1
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 medicine manufacturers must follow the same standards and regulations.
Teva is the largest manufacturer of generic medicines 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.
Why does it take time after a new brand medicine is introduced for a Teva generic to be made available?
When a brand name medicine is approved they typically receive a patent for their product that protects them from generic medicine competition for a period of time. This allows the brand manufacturer to recover their research, development, and marketing investments.2 You can be confident in knowing that Teva is constantly working to bring generic medicines to market when brand patents expire.
Where are Teva products made?
As the largest generic manufacturer in the world, Teva is able to offer more generic prescription medications than any other company through a seamless global supply chain. The US’s Food and Drug Administration, European Medicines Agency 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.1
1 FDA. Facts about Generic Medicines. Updated 04.06.2018
http://www.fda.gov/medicines/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericmedicines/ucm167991.htm Accessed 12.12.2018.
2 FDA. The Generic Medicine Approval Process. Updated 28.11.2017
https://www.fda.gov/Medicines/NewsEvents/ucm508150.htm Accessed 12.12.2018