Frequently Asked Questions About Generic Drugs

What are generic drugs?

Generic drugs are “unbranded” pharmaceutical products. They are medicines that contain the same active ingredients as an original brand-name drug, but they are generally less expensive.

How are generic drugs approved?

All drugs that are authorized for sale in Canada must undergo a similar review process and be approved by Health Canada (the federal regulatory authority). This federal agency is responsible for assessing the safety, efficacy and quality of all medicines. There are no differences in the quality and safety standards that generic drugs and brand-name drugs must meet.

When a generic drug is reviewed, the manufacturer has to demonstrate that the generic drug works similarly to and delivers the same amount of medicinal ingredient at the same rate as the brand-name drug, and is as safe and effective as the brand-name drug.

Why do generic drugs sometimes look different from the brand-name drugs?

In many cases, generic drugs match the size, shape, colour and taste of their brand-name counterparts. In other cases, there are differences. The important thing is that the generic medicines must have the same active ingredients and be “bioequivalent,” meaning they work the same way in your body as their brand-name counterparts. The differences in appearance do not affect the safety or effectiveness of generic medications.

The standards for bioequivalence in Canada are built upon internationally recognized standards and the criteria are among the highest in the world. Health Canada Scientists ensure that the standards for bioequivalence are adhered to and kept up to date as they work closely with an expert panel of Scientists, Physicians and Pharmacists from across Canada. Health Canada also regulates the non-medicinal ingredients, such as fillers and preservatives, for both brand-name and generic drugs and they are subject to the same approval process.

All provincial and territorial governments in Canada recognize Health Canada’s designation of equivalence and cover generic prescription medicines on their drug plans where possible.

Why do generic drugs generally cost less?

One of the main reasons generic medicines generally cost less is that researching, developing and marketing a new brand-name drug requires a lot of time and money. For this reason, when a new drug is created, manufacturers apply for a patent which allows the patent holder to have exclusive rights for a certain number of years to sell the drug and recover its initial investment. Eventually, when the patent nears expiration, generic drug companies can apply for permission to manufacture their own generic versions of the drug. As a result of having no start-up costs to develop the drug from scratch, they can afford to make and sell the medicine for less money.

How much can I save by taking a generic medication?

In Canada, generic drugs can be priced significantly lower than their original brand-name counterparts. However, there are a number of factors that contribute to the total cost of a medication, including whether you have insurance coverage. It’s best to talk to your Pharmacist or Doctor to learn about whether there may be any possible cost savings associated with taking an equivalent generic medication.

Are all brand-name drugs available in a generic form?

No. Brand-name drugs are developed under patent protection. In most cases generic drug companies apply to Health Canada to sell a generic version after the brand-name drug's patent(s) expire. As patents expire, generic versions of brand-name drugs continue to become available.

How can I find out the name of the company that is manufacturing and/or distributing my generic medication?

You may be able to determine the company that manufactures your generic medication by looking at the label on your prescription, checking your online account,* or by asking your Pharmacist.

Why are the names of brand-name drugs different from the names of generic drugs?

Drugs often have several names. The chemical name reflects the physical makeup of the drug and is also known as the “active ingredient.” The generic name is based on the drug’s chemical name and represents a commonly referred to name for both the generic and brand drug. The brand name is created by the pharmaceutical company for marketing the medication. For example: the brand Lipitor is also referred as the generic Atorvastatin.

What are active pharmaceutical ingredients (APIs) and inactive ingredients?

An active pharmaceutical ingredient (API) is the component of a drug responsible for the medication's effect. Generics are required by Health Canada to contain the same APIs as their brand-name counterparts.

Inactive ingredients, such as fillers and colourants, can give a drug its colour, size and shape. Generics must contain the same active ingredients as brand-name drugs but they do not have to be made with the same inactive ingredients, as these do not affect the therapeutic effect of the drug.

*Digital Pharmacy is not available in NL, PEI or YT.