Demystifying Generic And Branded Drugs

Demystifying Generic And Branded Drugs

“You want the generic or the original?” This question is often asked to you at the pharmacy when you buy a medicine. And what do you answer? Surely, you're in a state of confusion: Should I choose the cheapest one giving confidence to an unknown product? Or I go on the safe side and choose the original product? Which one to choose between the two? They are equally effective or it is one more than the other? Here in this article, we try to answer you all your medicine concerns!

1) What is a drug equivalent (or Generic Medicine)?

A: An equivalent or generic drug is a copy of its reference drug (drug "of a brand" or "designer") on the market for many years and whose patent has expired.

In fact, a drug equivalent (or generic) cannot be put on the market if the patent of the brand-name medication is still valid. The FDA defines the generic medicine as "a medicinal product which has the same qualitative and quantitative composition of substances active and the same pharmaceutical form as the reference medicinal product and a bioequivalence with the reference medicinal demonstrated by means of appropriate bioavailability ".

2) What are the Requirements for a Generic Medicine?

A: A Generic Medicine must:

Have the same active ingredient, i.e. the substance responsible for its effect drug (therapeutic);The active ingredient should not be protected by patent;Have the same pharmaceutical form and route of administration (e.g. Tablets, capsules, injectable solution, etc.);Have the same dosage unit;Be bioequivalent to the reference product;Have a cost of at least 20% lower compared to the same medicine reference.

Is there a generic equivalent for my brand-name drug?

A: You can find out if there is a generic equivalent for your brand-name medicine by browsingMediklik’s vast drug database, where you will get information about the generic composition of your brand-name drugs along with their therapeutic classification, ICD codes, typical uses, doses, contraindications, side-effects and interaction with other drugs. 

Why do generic drugs usually cost less than brand-name drugs?

A: When a brand-name drug first becomes available, the drug manufacturer normally gets a patent. This exclusive right protects the investment of drug manufacturer in the new medication by keeping other organizations from duplicating and manufacturing it for several years. 

When this patent runs out, other drug manufacturers can make a generic edition of the medicine. Generic drug manufacturers don't need to spend a fortune on research and development that the brand drug maker did. As a result, the expense is lower.

Why do generic drugs look different than brand-name drugs?

A: Trademark laws need that a generic medicine must look different from the medicine already on the market. Therefore, a generic version will be of different shape, size and/or color than the brand-name drug. Despite the fact that the active ingredient in a generic version is consistently the same as the brand-name counterpart, the generic might have varied inactive ingredients, for example, a flavoring or a coating. Moreover, since more than one producer can produce a generic equivalent for the same brand-name drug, generics may differ based on which drug manufacturer or manufacturers the pharmacy uses. 

How much will I save by taking a generic medication?

A: In the United States, on average a generic drug costs around 80-85% less than the brand-name drug. There are various factors that might add to the expense of a medication, for example, the drug store you go to or your health insurance coverage. It is best to consult with your physician or pharmacist to find out about the savings linked with taking a generic equivalent. 

What does it mean when a generic drug is bioequivalent to a brand medication?

A: The FDA demands generic drug applicants to experimentally exhibit that their medicine is "bioequivalent," implying that it works in the same manner as the brand-name drug. Bioequivalence is exhibited by demonstrating that the generic drug carries the same level of active ingredients into a patient's blood in the same time interval as the brand-name drug. One approach to demonstrate bioequivalence is to collect blood samples after the subject is provided the brand-name drug and then again after the subject takes the generic drug or vice versa to validate the generic medication level is practically identical to the brand. 

According to Food and Drug Administration, since the efficacy of the brand-name drug has already been set up, it is scientifically pointless to demand that large-scale testing is redone on human subjects for every medication.

How are generic drugs approved?

A: The Food and Drug Administration approves a generic drug via a process called ANDA (Abbreviated New Drug Application) that demands a generic drug producer to demonstrate that its drug is the same in strength, quality, and the manner it works to the brand-name drug. This "similarity" is commonly known as bioequivalence.

Why does a generic drug look different from the brand drug?

A: A generic drug may vary in color, size, shape or taste from the brand-name drug; though, it must have the exact active ingredient(s) and functions the same way as the brand-name drug. The changes in appearance don't influence the generic medication's effectiveness or safety.

Are all brand drugs available in a generic form?

A: No. Brand-name drugs are produced under patent protection. The maximum period of a drug patent is around 20 years. Usually, generic drug manufacturers first apply for the FDA approval to sell their generic after the expiration of brand-name drug’s patent. Ask your primary care physician or local pharmacist if generic drugs of your brand-name prescriptions are freely available. You can also check out the list of generic medicines approved by the FDA onMediklik’s Drug database. 

How can you learn more about generic drugs?

A: A primary care physician or local pharmacist can give you more information regarding generic medicines. You should consult with your doctor to determine if a generic medicine might be a choice for them. You can also visit Mediklik for more information about brand-name drugs and their generic equivalents.