What are Generic Drugs/Medicines?

Generic medicines are those which contain the same active content (the ingredient which acts to cure the condition the medicine is used to treat) in the same quantity as a brand-name medicine. Generic medicines therefore have the same effect on the body in terms of curing disease as the brand-name medicines which they copy.

Some basic FAQ’s related to Generic drugs:

What are the differences between generic and brand name drugs?

When the patent expires, other pharmaceutical companies may apply to the FDA for permission to manufacture and sell a generic version of the original compound. The generic drug manufacturer must prove that their product contains the same active ingredient(s) as the brand name product. They must ensure that their generic drug maintains the same form (liquid, pill, capsule, injectable, topical), concentration, and dosage as the original medication.

The FDA also requires that the generic version be as pure and stable as the original drug. The generic drug must follow the same distribution patterns and be metabolized and eliminated from the body like the brand name drug. Basically, the FDA ensures that a generic drug contains the same active ingredient in the same amount, and does the same job as the brand name product before it can be used as a substitute.

But there may be differences between brand name and generic drugs. Although the active ingredient must be the same as the original drug, generics may include different inactive ingredients such as preservatives or fillers. Trademark laws prevent generic drugs from looking just like the brand name drug, so the color and size may be different.

Why are generic drugs cheaper than brand name drugs?

Manufacturers of generic drugs do not have to repeat the years of costly laboratory and clinical trials that the developing company invested in to gain FDA approval. Generic manufacturers simply “borrow their neighbor’s homework” and don’t have to spend the time or money to do their own.

Since they can produce the medication at a much lower cost, it stands to reason that they can sell it at a lower cost and still make a profit. When several companies begin to manufacture the same generic medication, competition further keeps the price down. That’s why nearly 8 of 10 prescriptions in the United States are filled with generics.

Advantages of generic drugs

The major advantage of generic medicine use is the cost benefit. Generic medicine cannot be marketed at a price higher than the branded medicine, so it is often a cheaper option, both for the consumer and the government who pays for part of the cost of the medicine under the Pharmaceutical Benefits Scheme. This may help people to take their medications as prescribed by the doctor.

More expensive medicines can sometimes affect people’s ability to strictly adhere to the dosage schedule prescribed by the doctor, especially when there are many repeats and the medicine has to be purchased on multiple occasions. In many cases, not finishing all repeats will have negative health effects: the medication will not treat the intended condition as well as it should – for example, a person’s infection may not be completely eliminated if they stop taking antibiotic medicines too early (although they will often feel fine when they stop taking the medicine). Having cheaper medication available makes it financially easier to continue with the medication for the whole duration of the prescription.

However, over two-thirds (68%) of generic medicines are the same price as the original. Despite this, research shows that over half of people (55%) don’t ask their pharmacist if the generic is any cheaper before purchasing it. If cost is the same, most Australians (62%) would prefer the original medicine their doctor prescribed over the generic their pharmacist is offering.

Disadvantages of generic medicines

Consumer confusion

Without properly understanding the similarities and differences between generic and branded medicines, it is easy to become confused and anxious about taking a new medicine. This is particularly the case when someone is used to taking a certain medicine and is introduced to a new medicine that has a different name and appearance but is ‘the same’.

There are two main points that you need to understand if you are considering the switch to generic medication:

1. Even though a generic medicine may taste, look and be packaged differently, it has the same active ingredient as the branded medicine you are used to taking. Therefore, the two medicines cannot be taken together. This will lead to an overdose of that particular medicine. Always remember that one replaces or is substituted for another.
2. The generic medicine has been thoroughly tested by the pharmaceutical company and the TGA. The generic medicine is interchangeable with the branded medicine. This means that it will have the same actions in the body as the original medicine. The only differences exist in the inactive ingredients, which will not have any negative effect unless you have an allergy or intolerance. However, when treating certain critical conditions such as epilepsy, the normally acceptable equivalence range is too large. In these cases, your doctor will include instructions on the prescription that substitutes should not be used and the pharmacist must not offer you a substitute.

Not understanding that the new medicine is substituting a medicine already being taken can lead to:

• Decrease in medicine adherence due to confusion and anxiety about taking the new medicine; or
• Overdose toxicity due to taking both the branded and generic forms.

If you are not comfortable with the concept of generic substitution, do not switch medicines.