Frequently asked questions about 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.

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 performs similarly to the brand-name drug and that the generic drug delivers the same amount of medicinal ingredient at the same rate as the brand-name version.

In many cases, generic drugs match the size, shape, colour and taste of their brand-name counterparts. In other cases, there are slight 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 and hospitals in Canada recognize Health Canada’s declaration of equivalence and use generic prescription medicines wherever possible.

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, many companies apply for a patent, which allows the patent holder to have exclusive rights for a certain number of years to sell the drug and make up 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.

In Canada, generic drugs can be priced as low as 15% of their original brand-name counterparts. However, there are a number of factors that contribute to the total cost of a medication, including your insurance coverage. It’s best to talk to your Doctor or Pharmacist to learn about whether there may be any possible cost savings associated with taking an equivalent generic medication.

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.

Over the next few years, as more patents expire, generic versions of several top-selling brand-name drugs are expected to become available.

You may be able to determine the company that manufactures your generic medication by looking at the label on your prescription, reading the medication package insert or by asking your Pharmacist.

Drug products often have many different 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.

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.