Generic Drugs: Definition & Advantages

Instructor: Danielle Haak

Danielle has a PhD in Natural Resource Sciences and a MSc in Biological Sciences

A common debate: generic or brand name drug! Which is better? What is the difference? Do generics really stand up to the power of a brand name drug? Keep reading to find out the advantages of generic drugs and how they are approved!

Generic vs. Brand Name Drugs

If you have ever taken a prescription medication, you have probably been faced with this dilemma: should I take the generic or the brand name version of a drug? Does the generic version provide the same benefits as the brand name?

Let's look at the definition of a generic drug: a drug that is comparable to a brand listed drug in dosage form, strength, route of administration, quality and performance characteristics, and intended use. That sounds like a pretty solid case that they should be comparable. Let's compare further.

Are Generic Drugs Made Before or After the Brand Name Drug?

Well, generic drugs cannot hit the market until after the brand name drug's patent and exclusivity rights end. In some cases, the patent owner can waive their rights, but large pharmaceutical companies normally don't do this if their drug is profitable (obviously it makes sense to keep all your competitors out of the game as long as possible!). Patents for brand name drugs receive a pretty good head start - they usually get an average of 12 years of solo time in the game! Imagine playing basketball with no other team on the court - you would do pretty well for yourself if you had the first half with no competition!

What Requirements Do Generic Drugs Have to Meet?

Generic drugs must meet all of the same FDA (Food and Drug Administration) requirements as any other drug. This is pretty impressive. A generic drug has to have:

  • The same active ingredient
  • The same administration type (oral, topical, intravenous, etc.)
  • The same dosage
  • The same strength
  • The same conditions of use

In addition, all inactive ingredients must already be approved!

Basically, the only difference between generic and brand name is the type of animal and/or clinical studies that take place. Brand name drugs are paving the way, so they have more thorough animal studies, clinical studies, and bioavailability studies before the drug is approved. Makers of generic drugs just have to prove that their drug has the same bioequivalence (same absorption rates and extent) as the brand name drug.

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