frequently asked questions
What are generic drugs?
A: Generic drugs are unbranded pharmaceutical products. They use the same active ingredients as the original brand formulation and work the same way in the body, so they have the same therapeutic benefits but often cost less.
Are generic drugs as safe and effective as brand drugs?
A: YES! The Canadian Food and Drug Regulations require generic drug companies to scientifically demonstrate that their product is "bioequivalent" to the brand name drug, meaning equal in dosage, safety, strength, quality, the way it works in the body and the way it is taken.
Why do generic drugs cost less?
A: The effectiveness of the brand drug has already been established through clinical testing and years of patient use. As a result, Health Canada and regulatory bodies around the world agree it’s scientifically unnecessary to repeat that same level of testing for the generic drug. Generic drug companies also spend far less on marketing and advertising than do makers of brand name drugs. The savings are substantial and are passed along to you in the form of lower prices.
How much will I save by taking a generic medication?
A: In Canada, generic drugs cost an average of 60% less than their brand counterparts. There are a number of factors that may contribute to the cost of a medication, including the pharmacy you go to or your insurance coverage. It’s best to talk to your doctor or pharmacist to learn about the cost savings associated with taking an equivalent generic.
How are generic drugs approved?
A: Health Canada approves generic drugs through an Abbreviated New Drug Submission (ANDS) process that requires a generic drug maker to show that its medication is identical to the brand drug in quality, strength and the way it works in the body. This "sameness" is referred to as bioequivalence.
Why does a generic drug look different from the brand drug?
A: In many cases, a generic matches the size, shape, colour and taste of its brand counterpart. Sometimes there will be slight differences. The important thing is that the generic drug must have the same active ingredient(s) and be “bioequivalent,” meaning it works the same way in your body as its brand counterpart. The differences in appearance do not affect the generic drug’s safety or effectiveness.
Are all brand drugs available in a generic form?
A: No. Brand drugs are developed under patent protection that lasts 20 years. In most cases, generic drug companies apply to Health Canada to sell a generic version after the brand 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, giving you access to even more affordable medicines.
Ask your doctor or pharmacist if a generic version of your brand prescription is available.
How can I find out the name of the company that is manufacturing and/or distributing my generic medication?
A: You may be able to determine the company that manufactures your generic medication by looking at the label on your prescription drug, reading the medication package insert or by asking your pharmacist.
How do I read the label on my prescription drug package?
A: When using any medication, it's important to carefully read the prescription drug label. Here’s a color-coded guide to help you identify certain information contained on a typical drug label that a pharmacy puts on your medication. Note, the information provided on the drug label may differ depending on the pharmacy you go to or the province where you reside. Consult your pharmacist or doctor if you have questions about the label on your prescription drug package.
What are active pharmaceutical ingredients (APIs)?
A: An 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 counterparts.
What are inactive ingredients?
A: Inactive ingredients, such as fillers and colorants, can give a drug its color, size and shape. Generics must contain the same active ingredients as brand drugs but do not have to be made with the same inactive ingredients, as these do not affect the therapeutic effect of the drug.
Why are the names of brand drugs different from the names of generic drugs?
A: Drug products often have many different names. The chemical name reflects the physical makeup of the drug (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.