The U.S. Food and Drug Administration (FDA) require generic medications to have an indistinguishable execution and quality as like brand medication. The FDA says: "When a generic medication is approved, it has met thorough benchmarks set up by the FDA as for potency, strength, quality, and strength."
Tramadol is a pain reliever that could be used to treat moderate to severe pain. There are various medications on the market available to act as a pain reliever but most of the people used to prefer generic Tramadol as it is very much effective and could experience its effect within a short time. Ultram is the brand name of Tramadol. This medication belongs to opioid analgesics class and one could get it in various forms and dosages.
However, generic Tramadol differed from the brand formulation in some cases such as color, the inactive substance, and shape. In addition, one of the interesting and major differences between generic and brand Tramadol is cost variation - the generic Tramadol is 25% lesser than the brand drug price.
There are various brand names available for the generic Tramadol such as Con zip, Ultram, Ultram ER etc.
- It called as innovator drug because manufacture initially designed and produce branded name drug.
- Initially marketed as the new chemical substance for pain relief
- Brand drugs have a patent as well as copyrights
- It is the duplicate version of brand version pain reliever medication
- Manufactured after the expired of original or brand copyrights.
- Low cost
Why brand Tramadol called as innovator drug?
The brand Tramadol, Ultram called as innovator drug because it is the first medication which initially designed and formulated as a pain reliever drug. And the generic medication follows the same active ingredient of brand drug which means Tramadol copying the chemical so the brand drugs called an innovator drug.
Brand Tramadol is originally formulated and developed by Janssen pharmaceutical company and they have all rights to sell this pain reliever medication without any legality issues. But before that, they have to meet the clinical trial as well as the requirement of U.S. Food and Drug Administration (FDA). Once the medication has approved by FDA, then the manufacturing company can market and exclusively sell this brand medication until the expired of patent protection.
Is there any difference in generic and brand Tramadol dosage strength?
If inactive ingredient of the generic formulation varies from the brand formulation, it does not mean that the dosage strengths also vary. Both brand and generic variants come in same dosage strength such as 50 mg, 100mg, 150mg, and 200mg. When you find any difference in dosage strength, it might be a counterfeit or fake pill so be aware of it.
Tramadol is been manufactured in various forms and shapes. Tramadol tablet of different dosage is used to be manufactured in various batches. During the manufacturing process, the ingredients should be mixed in the correct composition and they would be compressed into units of the mixture and they are called as slugs. These slugs will then be filtered to remove the air and after removing the air they would be again compressed into separate tablets.
The active ingredient here in Tramadol is the Tramadol hydrochloride. And the other ingredients that have been used in this process are pregelatinized starch, magnesium stearate etc. Whereas in Ultram they also used to have Tramadol HCL but in an extended-release formulation. Other ingredients are ethyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol etc.
The appearance of the Tramadol and Ultram will vary. Tramadol is available in three shapes, one is elliptical and the other one is oval, and in round shape. They are usually present in white, green and yellow color with the dosage strength printed in the middle as “tram 50”. The dosage used to vary according to the person as everyone is unique. In Ultram, it will also be available in various doses, but Ultram would be imprinted in between the tablet. Color would be same as that of Tramadol.
Why the price of generic less than brand Tramadol?
The pharmaceutical company invests more than $800 million to develop a new drug for research, experimental or clinical studies, marketing, and development. In addition, the scientist, researchers, and doctors take almost 10 to 15 years in order to develop the brand Ultram medication to this pharmaceutical world.
On the other hand, generic formulation pain reliever drug does not require any sort of research, market, and development so that the generic drug manufacturer does not invest much for patent rights. However, Tramadol has to clear all the clinical test that conducted by U.S. FDA.
In addition, Tramadol released into the market after the Ultram patent exclusivity ends and minimum it will take 8 years. By means of that, Generic Ultram released without any startup cost so that the companies sell at 25% lesser. And the price range may vary from drug manufacturer to another manufacturer.
The cost would be the major change a person might experience when purchasing tramadol in generic and branded versions of Tramadol. Generic versions used to cost comparatively less, and this is due to various reasons. The branded Ultram costs high because they might have spent a lot of money in research and in the development of the product. And also for the promotion of the product, they had spent money and that is the reason why the branded one is costly. Also, only the branded version consists of the original composition.
Does the difference between the generic and branded affect the medical condition?
The effect would be somewhat less while taking Tramadol and it would be much effective when taking Ultram, because the ingredients would be the same but the compositions might differ. The branded version only will the original composition but all the generic versions will not be having the exact composition.
Is there any difference between Generic and Brand Tramadol side effects?
According to FDA, approved generic drug concentration will be 3 to 4 % lesser than brand drug concentration. And it is possible that brand concentration can be 3 % higher than generics. Thereby, totally the concentration can vary up to 5 to 6 % so the total effect of the medication will be almost same in people brain.
As a result, the side effects of both brand and generic medication will be similar but sometimes generic can cause a couple of side effects which are not enlisted in brand side effects list. However, they are very rare and minute.
Apart from these differences, you can find only one difference between these two medications; well that is a name of the medications.
Although both brand and generic Tramadol has the differences, the drugs are designed and produced to treat various types of pain conditions ranges from moderate to severe moderate. As FDA stated that Generic and Brand Tramadol effects, working mechanism and outcome result will be same so you can take any formulation of Tramadol as per your desire.