Generic medicine FAQ
We’ve provided these commonly asked questions about generic medicines to help provide the answers you want to know.
What are generic medicines?
Generic drugs offer a therapeutic alternative to innovative drugs. 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 drug names different from the original drug names?
All original drugs have a generic name. This name often appears next to the brand name and is the active pharmaceutical ingredient(s) in the medication. Regulators require that generic drugs are given a different name than the original drugs, 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 drugs 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 drugs safe?
A generic drug is bioequivalent to the original innovative drug and meets the same quality standards. The active ingredient, the content, the dosage form and the usage of a generic drug are similar to those of an innovative drug. Regulatory authorities review the safety of both brand and generic prescription drugs 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 drugs to ensure their efficiency and safety.
How do you ensure generic drug 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 drug, its purity profile is similar and it is found to be bioequivalent; therefore its safety and efficacy are also comparable.
Why are generic drugs cheaper?
Generic companies can offer their products to the public at considerably lower costs than brand-name drugs 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
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. Simply contact your pharmacy to inquire about the cost of your medication, and be sure to tell your pharmacist if you have insurance and if you prefer a Teva medicine.
Does every drug have a generic equivalent?
As long as a drug 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 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.
Does the generic drug look the same as its original equivalent?
Sometimes the generic version of a drug 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 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.01
Are all generic drug 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.
Why does it take time after a new brand drug is introduced for a Teva generic to be made available?
When a brand name drug is approved they typically receive a patent for their product that protects them from generic drug competition for a period of time. This allows the brand manufacturer to recover their research, development, and marketing investments.02 You can be confident in knowing that Teva is constantly working to bring generic drugs 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 FDA, EU 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.01
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FDA. Facts about Generic Drugs. Updated: 06/28/2016. http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm Accessed January 19, 2017.
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FDA. The Generic Drug Approval Process. Updated 06/23/2016. https://www.fda.gov/Drugs/NewsEvents/ucm508150.htm Accessed March 29, 2017.