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Tuesday, February 9, 2010

Brand vs. Generic

Pharmaceutical companies, such as Pfizer, AstraZeneca, Wyeth, etc. are businesses that invest in creating medications for our every day well-being. These can be blood pressure, cholesterol, antibiotics, analgesics (painkillers), or anti-psychotics. In order to create a new drug, the company must first develop a chemical. I'm going to use the drug Viagra as an example since everybody seems to know what that one's for. If you don't know, well, then you're retarded. Pfizer released Viagra in 1998. Pharmaceutical companies spend reported "millions and millions of dollars" on research and development in order to create a new drug. This money is also spent on tests and clinical trials.

Once a drug is developed by a drug company, they submit it to the Food and Drug Administration (FDA) for approval. After being approved, the drug receives a patent from the US Patent Office because technically, it is an invention. Drug patents can last between 2 and 17 years and is usually closer to the latter. During this time, the company spends more money on marketing and advertising in order to get the name of the drug out there to the public. This is when you see all the commercials on television.

Now, when you see the name of a brand name medication, you will see a big word underneath it usually in parentheses.
VIAGRA
(sildenafil citrate)
This word in parentheses is the chemical name of the drug--the active ingredient. Viagra's chemical name is sildenafil citrate. Just like all medication patents, Viagra's patent will expire. Its estimated expiration date is March 2012. When this date rolls around, a generic form of Viagra will become available. It will go by its chemical name of sildenafil citrate. Does this mean it's a totally different medicine? Quite the opposite. The name "Viagra" is a name that Pfizer came up with to call the drug. Even after the patent expires, the brand name drug will still be available.

Now let's look at cost. Why are brand name drugs more expensive and generics cheaper? As I mentioned before, pharmaceutical companies can spend a shit-ton of money on R&D for a single drug. After it is approved by the FDA, that company needs to start making its money back. How do they do that? Well, to begin with, drug representatives scoot around to doctors' offices dropping off information, samples, and stationary that is littered with the drug name. The doctor may or may not read about the new drug and decide it's worth prescribing. Now you have a prescription for a new drug. You take it to the pharmacy and with no insurance, you find out that your Viagra prescription is going to cost you about $150 for 10 pills. That's a real figure, too. Like I said, the drug company has to make their money back some way and in this case it's through the cost of the actual medication.

Let's fast forward to 2012. Viagra's patent has expired and "Company X" has decided to produce the generic form of Viagra. They will sell it to pharmacy wholesalers like Cardinal Health. Pharmacies that get their supplies from Cardinal Health will then order that drug. Now the pharmacy has the brand name and the generic form in stock. Our dilemma: which one do you choose and why?

As the FDA regulates all prescription and non-prescription drugs in the US market, it is their responsibility to ensure that the generic form of a drug be the same as a brand name drug in 7 categories. They are:

1) The generic form must be available in the same doses as the brand name. This means that since Viagra is available as a 25mg, 50mg, or 100mg tablet, the generic must come in those doses too.

2) The generic form must also be available in the same strengths. If Viagra contains 25mg of that active ingredient, sildenafil citrate, so, too must the generic.

3) The generic drug must be as safe as the brand name that was approved in the first place. If Viagra's main side effects are A, B, and C, sildenafil citrate's side effects cannot have a side effect of D.

4) The generic drug must be the same quality as the brand name drug. Just like the coke fiends who won't buy anything less than 60% pure, these drugs must match the brand name in quality.

5) The generic drug must work the same way as the brand name drug. If Viagra increases blood flow, so, too must sildenafil citrate. If Viagra is broken down and absorbed in the small intestine, the generic form must be absorbed into the body the same way. This is critical.

6) The way the drug is taken is also something the FDA looks for when approving a generic drug. If Viagra is only available as an oral tablet (which it is), then the generic must be taken that way as well.

7) Lastly, the generic drug must match the brand name drug in the way it is used. If viagra should be taken with food, so should the generic. If it needs to be taken 30 minutes to 4 hours prior to sexual activity, so should the generic.

Number 5 is known as bioequivalency. The definition of bioequivalency according to
Dictionary.com is "the condition in which different formulations of the same drug or chemical are equally absorbed when taken into the body." So, when someone tells you that the generic drug doesn't work the same, 99.99% of the time, it's all in their head. By FEDERAL LAW, it has to work the same.

I mentioned before that the chemical name is known as the active ingredient. If this is so, then what is/are the inactive ingredient(s)? Inactive ingredients are what make up the color, the shape, the size, etc. of the tablet or capsule. 99.99% of the time, these have absolutely no affect in the difference between generic and brand name drugs. These don't need to and don't have to be the same. The generic drug actually
has to look different or it infringes on copyright and patent laws. I can't make the same red fire truck you did and call it something else if it has your company name on it--mine has to look different somehow.

I have already mentioned cost. Since these generic pharmaceutical companies don't need to spend money on R&D, they can sell their product for less. The research and development has already been done by the brand name company. When the patent expires, this information becomes public knowledge.

What about those $4 and $10 programs?

The $4/$10 program is available at Wal-Mart, Target, Kroger, Giant Eagle, and Meijer. These big stores can afford to do this because they make money on other sales in their stores. When they give you a prescription for $4, they do not, I repeat, DO NOT bill your insurance company. They just set it to the $4 or $10 price and give it to you. CVS and Walgreen's cannot afford to do this because the majority of their business comes from prescription sales and the do not make up sales in the front store. This is a good idea for people with no insurance. If you don't have insurance, go to one of the $4 program stores and see how cheap it is. If you have insurance, it won't make a difference unless you tell the bigger store not to bill your insurance.

Let's recap:

1) Generic drugs are, BY LAW, the same as brand name drugs. They work the same!

2) Generic drugs cost less because the generic drug manufacturer doesn't need to make their millions and millions of dollars back due to R&D.

3) If you don't have insurance, go to a big store and leave us at CVS, alone.

So why get brand name drugs? See? You don't even have a reason. Most of the time, pharmacies dispense generics by default anyway.
Just get the generic...


I'd like to thank Adam M. for sharing this with me. It was a message he sent me:

It IS a giant myth that drug companies need to maintain their hold on the market. Do you wonder why al this r and d never leads to any great new cures. It is because the drug co. know the best way to profit is to grab a share of something already making a ton of money. That is why you have nexium, prevacid, protonix-they were developed to grab a share of old prilosecs earnings. Crestor the same with lipitor. Cholesterol, diabetes, ppis. Just a few different categories but all these variations. Nothing pioneering or revolutionary. At 1:05 lok at the chart. That chart is based on the companies listed on the bottom own figures. THEIR OWN figures they submit for analysis. Look at it: R and D is half of what they spend on marketing... This information is out there, the companies themselves don't hide it, but peope believe the same old myth.

http://www.youtube.com/watch?v=kWLQpnRlt5A

3 comments:

  1. It is true that generic drugs should produce similar effects as branded drugs do. The quality of these generic medicines could not be compromised and should remain identical and as safe as the branded ones. This can be possible by utilizing NIR technology, which uses quality control methods by checking the blend uniformity, granulation, drying, coating, etc.

    ReplyDelete
  2. Viagra is Good medicine to helping people who has suffering from ED.
    Generic Viagra

    ReplyDelete
  3. Viagra is the first product to be introduce for impotency.Generic Viagra was introduced afterwords.Viagra it self is a brand and is very effective.thanks for the post.keep posting.

    ReplyDelete