We’ve provided these commonly asked questions about generic medicines to help provide the answers you want to know.
A generic medicine is a medicine that is an equivalent substitute to a brand name drug. 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 drug must work the same way in your body and produce the same treatment result as the brand name drug 01.
All brand-name drugs 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 drugs are given a different name than the brand-name drugs, 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 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. Ask your pharmacist if you have any questions.
A generic drug is bioequivalent to the brand-name 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 02.
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.
Generic companies can offer their products to the public at considerably lower costs than brand-name drugs because generic manufacturers do not 03
Often, approvals will be granted to multiple generic drug companies to manufacture generic equivalents which increase the competition in the market, thus driving the cost down 04.
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.
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.
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 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 05.
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 FDA, EMA and other major regulatory authorities inspect each of our facilities to ensure our products meet the same standards of good manufacturing practices as brand-name medications 06.
FDA. Be safe Rx. Updated 02/13/2018. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/BuyingMedicinesOvertheInternet/BeSafeRxKnowYourOnlinePharmacy/ucm294170.htm#risks Accessed October 23, 2018.
IQVIA NPA Data (as of MAT Sept 2018) on file at Teva.
Internal Data on File.
FDA. Facts about Generic Drugs. Updated: 06/04/2018. http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm Accessed October 23, 2018.
FDA. Generic Drugs: Questions and Answers. Updated 06/04/2018. http://www.fda.gov/drugs/resourcesforyou/consumers/questionsanswers/ucm100100.htm Accessed October 23, 2018.
FDA List of Authorized Generic Drugs. Updated 09/27/2018. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm126389.htm Accessed October 23, 2018.