Generic Medicines FAQs

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 drug¹.

______________________________________________

[1] FDA. Generic Drugs: Questions & Answers. Updated 06/01/2018
https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers
Accessed December 2, 2019

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. 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 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, to ensure that the generic medicine works in the same way and provides the same clinical benefit as its brand-name version¹. They also continue to monitor the safety of both brand and generic prescription medications after approval².

______________________________________________

[1] FDA. Generic Drugs: Questions & Answers. Updated 06/01/2018
https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers
Accessed December 2, 2019

[2] FDA. Generic Drug Facts. Updated 06/01/2018
https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
Accessed December 2, 2019

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 prices 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

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 down². 

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.

______________________________________________

[2] FDA. Generic Drug Facts. Updated 06/01/2018
https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
Accessed December 2, 2019

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 the innovative original. That’s because the appearance of a brand-name drug may be proprietary to 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 same².

______________________________________________

[2] FDA. Generic Drug Facts. Updated 06/01/2018
https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
Accessed December 2, 2019

No two pharmaceutical 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 118 years of experience, Teva is committed to meeting and often exceeding each country’s regulatory and quality standards, and providing affordable and quality medications.  Some patients feel more comfortable choosing a generic by a company they trust.

As the world’s leading generic manufacturer, 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.