The History Behind Generic and Brand/Trade Name Drugs

It has been a matter of debate and discussion among healthcare providers about the value, faults, compliancy, therapeutic efficacy, physicians’ prescribing patterns, and patient preference for brand name drugs and generic drugs. In order to understand this controversial issue one must first get a good definition of what generic and brand name drugs are.

What are brand name drugs?

According to the University of Michigan Health System, brand name drugs are “new drugs protected by patent and made by just one company.” A brand name drug cannot be produced or sold by any other company.The patent protects the investment in the drug’s development by giving the company the sole right to sell the drug while the patent is in effect. According to the FDA, brand name drugs are generally given patent protection for 17-20 years from the date of submission of the patent.

What are generic drugs?

A generic drug is the chemical equivalent of a drug.  When a brand name drug’s patent expires, other pharmaceutical companies can produce the same active chemical compound and sell the drug under its generic name. According to U.S. Food and Drug Administration rules, generic drugs must contain the same active ingredients as the brand. Generic drugs can sell for less because their manufacturers don’t have to go through the same research and development process (which is very expensive) that the drug’s original maker did.

Source : VK Sharma, Pranav Sharma, Lubhan Singh, VP Yadav, Kamal Dua 2009

http://www.pharmabiz.com/article/detnews.asp?articleid=51151&sectionid=46

FDA U.S. Food and Drug Administration, May 12, 2009

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm144456.htm

University of Michigan Health System, August 11, 2008

http://med.umich.edu/1libr/aha/aha_genbrand_crs.htm

 

How Are Generic and Brand Name Drugs Alike/Different

Now that you have been informed of what generic and brand name drugs are it’s time to go a step further and look at the make-up of generic and brand name drugs. What really makes generic drugs different from brand drugs?  How are they similar? Why pay more for a brand name drugs when you can get it cheaper as a generic? Does paying less money mean the drug is less effective?  These are all questions I’m sure you have wondered when choosing between buying a generic or brand name drug.  Below will help give an answer to some of these questions. 

How are they alike?

A generic drug is the same as a brand name drug in strength, quality, dosage, safety, how it works, how it is taken, and how it should be used. The Food and Drug Administration (FDA) stated that all drugs must work well and be safe. Both generic and trade name drugs have the same risk and benefits. Generic drugs have the same active ingredients and effects as brand name drugs.

Before approving a generic drug product, FDA requires testing and procedures to ensure that the generic drug can be substituted for the brand name drug. By law, generic drug products must contain the identical amounts of the same active drug ingredient as the brand name product. Once all the equivalency test have been conducted and approved, the generic drug is considered a therapeutic equivalency. Therefore there should be no difference in therapeutic effects when substituting a brand name drug for a generic drug.

How are they different?

Generic drugs look different from brand-name drugs. This is because trademark laws do not allow generics to look exactly like brand-name drugs. Colors, flavors, packaging, and other inactive ingredients may be different. These differences may cause slightly different effects. Some brand-name drugs may be more easily absorbed by the body. Brand-name drugs may cause fewer or weaker side effects. Because of these differences, the generic drug manufacturers are required to submit additional paperwork to the FDA to prove that their product is manufactured in accordance with good manufacturing practices (GMPs), and is as pure and stable as the brand-name product. The main difference is cost.  According to the FDA, on average, the cost of a generic drug is 80-85% lower than the brand name product.

So if the generic version has the same effectiveness and saefty as the brand-name version, what is the advantage of generic drugs? One word: price. Lower costs are often the reason why so many consumers have lean toward buying generic products rather than brand name. The reason Generic drugs are cheaper is because generic drugs do not have to go through the extensive testing that brand name drugs do.  According to Melissa Jeffries, author of “How Generic Drugs Work”, it takes years to create a drug and once a company creates a drug, it must conduct expensive clinical trials to ensure the drug’s safety and efficacy. In order for companies to compensate for their financial loses they charge premium amount for their drug. Generic drug companies, on the other hand, are paying only for the production of the medication so they can afford selling their drugs cheaper.

Source:

FDA U.S. Food and Drug Administration, July 10, 2009

 http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134154.htm

FDA U.S. Food and Drug Administration, 10/13/2009

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm

 Melissa Jeffries, “How Generic Drugs Work”, October 11, 2007

http://health.howstuffworks.com/health-illness/treatment/medicine/medications/generic-drug1.htm

Scientific American, December 13, 2004

http://www.scientificamerican.com/article.cfm?id=whats-the-difference-betw-2004-12-13