report

Debunking the Myth That Generic Drugs Are Inferior to Brand Name Drugs

Source

Brand Name vs. Generic Drugs

“He ordered what? I am not taking that garbage!” This statement was made by a patient who became visibly upset after being told that her doctor had prescribed a generic medication for her. The patient in this case had never used the ordered medication before—but was positive about its inferior quality.

As a Registered Nurse, I have interacted with many patients who truly believe that generic medications are poor-quality drugs reserved for lower-class people. Some have described generic drugs as watered-down products made from the remnants of brand name drugs.

I have heard patients insisting that the generic form of their pain medication will not work or has not worked. Patients have gotten angry at their doctors and have gone to the extreme of requesting the services of other doctors who, in their belief, will show respect by prescribing brand name medications.

These misperceptions about the inferior quality of generic medications seem to be held by many—when, in fact, prescribing a generic product is often a wise and practical decision on the physician's part.

According to the Food and Drug Administration (FDA), there is no support for the argument that brand name drugs work better than generic drugs.

Finpecia vs. Propecia

Finpecia a generic drug used to treat male pattern baldness. The brand name counterpart is Propecia.
Finpecia a generic drug used to treat male pattern baldness. The brand name counterpart is Propecia. | Source

What Are Generic Drugs?

Generic drugs are drugs that are sold under their chemical names and are identical to brand name drugs in all significant areas. The significant areas are: active ingredient, intended use, route of administration, strength, dosage form, quality and performance. [1]

Generic drugs are not always sold under their chemical names. Generic drugs may be sold under the name of the store that carries them. For example, Benadryl is a brand name drug. The generic form of Benadryl is sold by Walgreens pharmacy under the name of Wal-Dryl.

Generic and brand name drugs are not placed on the market unless deemed safe by the FDA. The FDA is a public health agency of the United States that is charged with evaluating the safety of food, drugs, and cosmetics that are placed on the market.

Generic Name Usually Appears Beneath Brand Name

The generic name of a drug is usually written under the brand name of the product label. Pregabalin is the generic name of the brand name medication Lyrica. Lyrica is used to treat pain caused by nerve damage
The generic name of a drug is usually written under the brand name of the product label. Pregabalin is the generic name of the brand name medication Lyrica. Lyrica is used to treat pain caused by nerve damage | Source

Evaluation of Generic Drugs

Before a generic drug is placed on the market, the FDA will do an evaluation to determine whether it is bioequivalent to the brand name drug it is modeled after. Human subjects are used, and blood is drawn routinely for testing.

Generic drugs are bioequivalent to brand name drugs if they have the same pharmacokinetic and pharmacodynamic qualities as brand name drugs. [1]

Pharmacokinetics refers to how the human body affects a particular drug product after ingestion. Pharmacokinetics looks at the absorption, distribution, and localization of the drugs within the body. Pharmacokinetics also looks at the biotransformation (chemical changes) and the excretion of the end products of a drug.

Pharmacodynamics refers to the physiological and biochemical effects on the body. Pharmacodynamics of a drug evaluates the drug actions and the relationship between the drug's concentration at different times in the human body.

A generic drug and a brand name drug are bioequivalent if they have the same pharmaceutical and therapeutic effect on an individual under similar conditions. Bioequivalent drugs have same bioavailability (the speed at which a drug absorbed) to tissues after administration of a similar dose at the same rate, resulting in the same efficacy, performance, and safety. [2]

According to the FDA, a slight deviation in absorption is not considered clinically significant. As such, a generic drug is still bioequivalent to brand name drug if it falls within 80-125% of the absorption rate of their brand name counterpart under similar conditions. [2]

The FDA also looks at purity in its evaluation of drugs. They may allow some slight variation in purity and strength of both generic and brand name drugs during preparation in plants. [3] However, only minimal variations are allowed and such variations do not affect the efficacy of either a brand name or generic drug.

Generic drugs are expected to meet the same quality standards as brand name drugs. There is no discrimination in the evaluation process conducted by the FDA. They expect the same level of performance from generic drugs as the brand name drugs they are modeled after.

Bioequivalence of Drugs

The blood concentration time curve of the generic drug Bupropion is within the 80-125% absorption range of the brand name drug Wellbutrin, making them bioequivalent
The blood concentration time curve of the generic drug Bupropion is within the 80-125% absorption range of the brand name drug Wellbutrin, making them bioequivalent | Source

Cipro

Cipro and Ciprofloaxin are comparable in all aspects
Cipro and Ciprofloaxin are comparable in all aspects | Source

Comparison: Generic vs. Brand Name

I have outlined the comparison between a commonly used brand name and its generic counterpart. Cipro is a brand name antibiotic commonly used for urinary tract and abdominal infections. Ciprofloxacin is the generic form of Cipro, and it is also used to treat urinary tract and abdominal infections. The adult dose of both Cipro and Ciprofloxacin for treatment of an uncomplicated urinary tract infection is 200 mg by mouth every 12 hours.

The half life of Cipro is 3-4 hours. [4] The half life of a drug is best defined as the time it takes for a drug in human plasma to be reduced to one half of its original concentration.

The half life of Ciprofloxacin is also 3-4 hours. Cipro works by interfering with the cell walls of bacteria, thereby inducing death. [5] Ciprofloxacin works in exactly the same way.

Both Cipro and Cipofloxacin peak at one (1) hour. Medication peak means the highest concentration of drug that will be found in the blood at any time during the administration of the medication.

A person who is allergic to Cipro will also be allergic to Ciprofloxacin. Both drugs have the same shelf lives. [7] Both Cipro and Ciprofloxacin ordered on one date will have the exact same expiration date. They both have the same chemical formula of C17H18FN303 and molecular mass of 331.346g/mol.

People who are hypersensitive to Quinolones cannot use either Cipro or Ciprofloxacin. Both drugs must be used with caution in patients with renal diseases. Common side effects of both drugs are dizziness, nausea, and rash. Both Cipro or Ciprofloxacin may interact with other medications in the same manner. For example, both drugs will decrease the absorption of antacids that contain magnesium. Both drugs may interact with Warfarin by increasing Warfarin levels. [6]

As such, the only differences between Cipro and Ciprofloxacin, as with other generic and brand name drugs, are in their colors, shapes, and sizes.

Generic vs. Brand Name: Same Active Ingredients

Medication
Brand Name Active Ingredient
Generic Active Ingredient
 
Anusol
Hydrocortisone
Hydrocortisone
 
Advil
Ibuprofen
Ibuprofen
 
Unison
Doxylamine
Doxylamine
 
Tylenol
Acetaminophen
Acetaminophen
 
Robitussin
Dextromethorphan Guaifenesen
Dextromethorphan Guaifenesen
 
Pepto Bismol
Bismuth Subsalicylate
Bismuth Subsalicylate
 
Rogaine
Minoxidil
Minoxidil
 
Dulcolax
Bisacodyl
Bisacodyl
 
Benadryl
Diphenhydramine
Diphenhydramine
 
Claritin
Loratidine
Loratidine
 
Allegra
Fexofenadine
Fexofenadine
 
Oragel
Benzocaine
Benzocaine
 
Sudafed
Pseudophedrine
Pseudophedrine
 
Tums
Calcium Carbonate
Calcium Carbonate
 
Prilosec
Omeprazole
Omeprazole Magnesium
 
Tagamet
Cimetidine
Cimetidine
 
Metamucil
Psyllium
Psyllium
 
Maalox
Simethicone
Magnesium Hydroxide,Aluminum Hydroxide
 
Imodium
Loperamide
Loperamide
 

Active Ingredients of Drugs

One easy way for consumers to evaluate generic and brand name drugs is to read labels. Almost all brand name drugs that are available over the counter (OTC) have their generic names written under the brand name. This is often written in parentheses.

Generic drugs and brand name drugs have the same active ingredients. The active ingredient of a drug is the main ingredient that is intended to treat, cure, diagnose, minimize, or prevent the disease. Drugs may have more than one active ingredient.

A rule of thumb is to compare the active ingredients of drugs. This can easily be done with OTC drugs that are available to consumers. The active ingredients of an OTC drug are usually listed on the back of the product.

Let's evaluate two common drugs, Rogaine and Robitussin, by looking at their active ingredients.

Rogaine vs. Minoxidil

Rogaine is a popularly known and FDA-approved dermatological solution used for hair re-growth. Pharmacies and other companies sell Roganie, as well as the generic counterpart, Minoxidil. For example, Equate is a discount company that sells its products through pharmacies such as Target and Wal-Mart. Equate markets Rogaine under the generic name of Equate Minoxidil. Equate Minoxidil is also approved by the FDA.

A consumer who is experienced in reading labels would immediately notice that the active ingredient necessary for hair re-growth listed on the reverse side of both the Equate Minoxidil package and the Rogaine package is Minoxidil 2%.

A three-month supply of 2% strength Rogaine is available for approximately $45.00 at Wal-Mart and Target pharmacies. A three-month supply of the Generic Equate Minoxidil is also available at the Wal-mart and Target pharmacies for approximately $18.00.

Rogaine is beautifully packaged and has a pleasant perfume-like fragrance. Equate Minoxidil is less attractively packaged. Equate Minoxidil has a slight alcohol-type odor.

Months ago, I pointed out the lack of difference between the active ingredients of the two products to a friend. My friend was under the assumption that the expensive, more pleasant smelling product worked better. I asked my friend: why was the more expensive product better? Her response was, “Because this one is Rogaine.”

Active Ingredient in Tussin: Dextromethorphan

Generic Tussin
Generic Tussin | Source

Robitussin vs. Generic Tussin

Robitussin is a brand name cough suppressant and expectorant formula medication used to reduce cough and expel the extra mucus that helps to create cough. Shop-Rite sells Robitussin and the generic counterpart, Tussin. Both Robitussin and Tussin have the same active ingredients: 10 mg Dextromethorphan and 100 mg Guaifenesin. Dextromethorphan acts as the cough suppressant, and Guaifenesin acts as the expectorant.

Based on the information already presented, Robitussin and Tussin are bioequivalent drugs with the same therapeutic impact upon the body. Shop-Rite has even gone out of its way to instruct the public on its Tussin label to “compare to active ingredients in Robitussin Cough + Chest Congestion.”

Despite the equivalency of Robitussin and Tussin, there are individuals who have declared that they don’t use the “cheap stuff," i.e., Tussin, because they believe it does not work as well as Robitussin.

The FDA’s Orange book may help to clear up this misperception.

FDA's Orange Book

Consumers who need information on generic drugs may refer to the FDA’s Orange Book. The Orange Book is a publication by the FDA that contains a list of generic drugs that are approved under the Federal Food, Drug, and Cosmetics Act.

The Orange Book is available online. It outlines all approved drug products with their therapeutic equivalence evaluations. The information on generic drugs is updated daily so that consumers have current information at all times. Consumers may enter the active ingredient of a brand name drug into the online search box to get the name of the generic equivalent. Consumers may also search drugs by their brand names which will also give the generic equivalent.

The Orange Book also provides information on which Drugs are available by prescription, over the counter (OTC), as well as discontinued drugs. The Orange Book also provides information on drugs that are alternatives to brand name and generic drugs. These drug alternatives are considered to be therapeutically equivalent.

The electronic Orange Book is easy to navigate on the website. A PDF copy of the drug information can be retrieved by going to the electronic Orange Book home page for a download. Any information on generic drugs that is not found in the Orange Book may be obtained by reaching out to the FDA at: FDA, Freedom of information Office HF1-35, 5600 Fishers Lane, Rockville, MD 20857. Phone: (301) 827-6500.

The FDA does not advocate the use of any specific drug. However, it has taken active steps to reinforce to the public that generic drugs are comparable to brand name drugs.

Bioequivalence: A Reminder

Generic drugs are bioequivalent to brand name drugs. Generic and brand name drugs have the same active ingredients, intended use, route of administration, strength, dosage form, quality, and performance rate. Generic drugs cost less than brand name drugs.

Common Brand Name Drugs and Their Generic Counterparts

Request a generic medication from your doctor. A generic medication affords you the same quality drug. There are no extra fillers, dyes, impurities, or inactive ingredients in generic drugs. Here is a list of common medications so you know what to ask for.

  1. Allegra - Fexofenadine hydrochloride
  2. Ambien - Zolpidem
  3. Dilantin - phenytion
  4. Elavil - amitriptyline
  5. Proventil - Albuterol
  6. Valtrex - Valacyclovir
  7. Viagra - Sildenfil
  8. Vicodin - Hydrocodone and acetaminophen
  9. Valium - Diazepam
  10. Synthroid- Levothyroxine
  11. Atarax - hydroxyzine
  12. Nexium - Esomeprazole
  13. Cleocin - Clyndamycin phosphate
  14. Vasotec - enalapril
  15. Reglan - Metoclopramide
  16. Pecid - famotidine
  17. Micronase - Glyburide
  18. Percocet - Oxycodone Hydrochloride
  19. Plavix - clopidogrel
  20. Duricef - Cefadroxil
  21. Lipitor - Atorvastatin
  22. Lopressor - Metoprolol
  23. Micostatin - Nystatin
  24. Lasix - furosemide
  25. Orinase - Tolbutamide
  26. Zantac - ranitidine
  27. Procardia - nifedipine
  28. Cipro - Ciprofloxin
  29. Levitra - vardenafil
  30. Maxzide - triamterene and hydrochlorothiazide
  31. Inderal - propranolol
  32. Keflex - cephalexin
  33. Prozac - fluoxetine
  34. Propecia - finasteride
  35. Xanax - Alprazolam
  36. Amoxil - Amoxicillin
  37. Plan B - Levonorgestrel
  38. Zovirax - Acylovir
  39. Tegretol - Carbamazepine
  40. Capoten - Catopril
  41. Ativan - Lorazepam
  42. Zyrtec - Cetirizine

Reasons Why Generic Drugs Cost Less

Generic drugs cost approximately one-third the price of brand name drugs. The use of generic drugs is said to save consumers up to $11 billion each year. Patients with certain chronic conditions are reliant on drugs for the rest of their lives, making the use generic drugs more practical. Thanks to the lower cost generic drugs, people in countries like Africa can afford to treat conditions such as HIV, as brand name drugs for this condition in that country are unaffordable.

It should never be assumed that generic drugs cost less than brand name drugs because they are less effective or that they contain fewer ingredients. Generic drugs cost less for specific reasons. Manufacturers of brand name drugs usually have a patent that may last up to 20 years on their drugs. The patent is usually granted after submission to the FDA. No other company can sell the brand name drugs during the patented period. As such, there is no market competition during this period allowing manufacturers to sell at higher cost.

The manufacturers of brand name drugs are also subject to very high costs for research, drug testing, and advertising. Manufacturers take the liberty of passing off these costs to consumers.

Sellers of generic drugs are not subject to these research and advertising costs because they can only sell versions of these already-tested and researched drugs after the brand name manufacturers lift their patents. As such, providers of generic drugs can afford to sell their products at a much lower cost.

Many manufacturers of brand name drugs will make generic versions of their own brand name drugs to compete with generic sellers after patents are lifted.

Psychological Resistance

Sometimes an opinion that a generic drug does not work may be purely psychological. Physicians have been known to order placebos for patients who constantly request particular drugs.

Many years ago, I interacted with a patient who frequently refused to accept Oxycodone Hychloride (Oxycodone) for her pain. Oxycodone Hydrochloride is the generic form of Percocet. The patient insisted that Oxycodone was “garbage” and expressed the opinion that only Demerol worked. Demerol is a brand name schedule II Opiod controlled substance.

In response to the patient’s constant requests for Demerol and refusal of the Oxycodone, the physician wrote an order instructing nurses to administer a placebo of 2 mls of normal saline intramuscularly instead of Demerol. Normal saline is a sterile salt water solution. Upon administration of the placebo by nurses, the patient expressed relief and would fall asleep within minutes. While this was arguably a deceptive practice not condoned by all, the patient’s response to the salt solution clearly suggests that the efficacy of a medication may result from a patient’s perception of the drug.

Please note that neither the American Medical Association, nor the Joint Commission that accredits health care facilities, sanctions the use of placebos in health care facilities.

Conclusion

Misperceptions about generic drugs come at a cost—as insurers are forced to pay more for drugs that have less expensive equivalents. With good cause, many insurance companies have taken steps to impose a different co-pay for brand name drugs, as opposed to generic drugs. Some companies will not pay for a brand name drug if the generic brand is available.

Generic drugs are comparable to brand name drugs and are less expensive. The FDA provides adequate oversight of the pharmaceutical industry. Consumers can rest assured that the generic drugs placed in the stream of commerce are safe, high-quality products.

Designating some brand name drugs as non-covered drugs, and mandating that the consumer pay a percentage for them, are subtle ways of encouraging more public education and utilization of generic drugs.

Sources

[1] Facts about Generic Drugs. FDA. USA Drugs and Administration http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm

[2] Orange Book Annual Preface, Statistical Criteria for Bioequivalence” Approved Drug Product with Therapeutic Equivalence Evaluations 29th Edition. US. Food and Drug Administration Center for Drug Evaluation and Research. 2009-06-18. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm

[3] Facts about Generic Drugs. FDA. USA Drugs and Administration http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm

[4] Mosby Nursing Drug Reference 2005.

[5] Kohanski MA, Dwyer DJ, Collins JJ (2010) How antibiotics kill bacteria: from targets to networks. Nat Rev Microbiol 8: 423–435. [PMC free article] [PubMed]

[6] Mosby Nursing Drug Reference 2005.

[7] Ciprofloxacin. Available at: http://en.wikipedia.org/wiki/Ciprofloxacin

Would you Consider Using a Generic Medication?

Are you more likely to use a generic drug after reading this article?

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20 comments

THarman7 profile image

THarman7 2 years ago from Lacey Washington

Not only did your hub have some great information but you put a lot of work into it. Thank you for sharing


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

Thanks for stopping by! Really appreciate it!


billybuc profile image

billybuc 2 years ago from Olympia, WA

I've heard friends say that and I just shake my head. What nonsense! Good job of debunking....I've always loved that word by the way...debunking. LOL


HSchneider 2 years ago from Parsippany, New Jersey

I work as a Supervisor in a drug store and I am always amazed how many people insist on only purchasing a brand name product. The ingredients are exactly the same and work the same way for much less money. The patent has expired so other firms are now allowed to manufacture that product. I buy generic whenever possible. Great hub, Cecileportilla.


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

Thanks for stopping by billybuc. Yes, people just say things about generic drugs without any real support for their reasoning.


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

HSchneider:

I am happy that as a supervisor in a pharmacy that you buy generic drugs whenever possible. I do the same!


Carol Reed profile image

Carol Reed 2 years ago from Remote

I have to say I prefer generic over brand because of cost and most have performed same results, however I must also say there are times when generic just don’t work the best for me. Thank you for sharing your interesting hub.


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

Thanks for stopping by my hub Carol Reed! If a generic drug does not work in the same way for you then this is information that may be of interest to the FDA since generic and brand name drugs are the same.

I believe that this is the web site information for making a report.

http://www.fda.gov/Safety/ReportaProblem/default.h...


DonnaCaprio profile image

DonnaCaprio 2 years ago from Newburyport, MA

This information is very helpful. I would sometimes buy generic and sometimes buy brand name drugs , because I wasn't sure they were always the exact same. I think the idea that brand name drugs are better comes from the fact that with clothing, furniture, cars, shoes and many other items, brand names are often better quality. There can even be a difference with food. Thanks!


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

You are so right regarding perceptions based on those other items !

However, those items (except foods) are not subject to FDA regulation and that makes a difference. Thanks for commenting!


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

Hi nevergrup:

Your link is written in a foreign language. Please translate what you are trying to convey!


DDE profile image

DDE 2 years ago from Dubrovnik, Croatia

I avoid the use of tablets unless it is my last resort. An interesting insight you have on this informative topic.


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

Thanks for you comment DDE. Really appreciate it!


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

Hi coffeewaiter:

Thanks for dropping by my hub. I appreciate your comments!


tobusiness profile image

tobusiness 2 years ago from Bedfordshire, U.K

Excellent hub! there are many misconceptions about drugs, you've done a great job of clearing up some of the myths about generic and brand named drugs.


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

Thank you for your comment tobusiness. I hope that this hub clarifies the misconceptions for many!


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

Hello ThreseDifference. As a Nurse and consumer I have to disagree with you regarding the quantifiable difference. The research does not support your views. The FDA does not seem to accord with your views.


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

Hello Carol Reed. As a Nurse and consumer I have to disagree with you. If a generic drug does not work then the brand name counterpart also does not work. The research accords with my view that there are no differences. The FDA website should be helpful in providing you with more answers.


CRAIG 2 years ago

Listen I've worked in the pharma industry for years as a buyer for a major wholesaler - I've liased with reps time and time again and I understand all the pros and cons - bio equivalents etc. recently I've become a patient who needs to take (far more than I'd like) many different drugs and I've been gobsmacked at my personal experiences with generics. There are many which just don't achieve what the premium brand can therapeutically? Everything from infections which wouldn't clear up to severe reflux which couldn't be controlled. I was all for buying the less expensive brand, putting more money in the pharmacists pocket and saving the govt on gap fees. But no matter how hard I tried to comply the medications just didn't do the job they were supposed to. From my experience I can only put it down to manufacturing and storage processes because as you stated they are supposed to work (almost) identically! At the end of the day as a patient I can only go with what gets the job done better and at least 75% of the generics I have taken just do not compared with the premium product. All the science and argument counts for nothing when you need it to count and it simply falls short if the mark.


cecileportilla profile image

cecileportilla 2 years ago from West Orange, New Jersey Author

Thank you for your comment Craig.

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