Again there is a wide discrepancy between estimates of the actual cost and time required, but I have attempted to provide an unbiased estimate using a variety of sources. Because patents are typically granted during the initial research phase of investigation, a company developing a new drug usually has 10 years of patent protection at the maximum except in rare cases of "orphan diseases" during which the drug is on the market.
Thus, the higher prices of brand-name prescription drugs arise because companies have to recoup their investment during the lifetime of the patent, typically seven to 10 years, as well as make a profit on the sale. This response represents a simplified case study and there are many examples of drug development that do not fit this profile precisely. For some brand-name drugs the developmental time frame is shortened somewhat, but there are many others in which it can last much longer. Sign up for our email newsletter.
Already a subscriber? Sign in. Thanks for reading Scientific American. Create your free account or Sign in to continue. See Subscription Options. Discover World-Changing Science. Get smart. Sign Up. Support science journalism. Knowledge awaits. See Subscription Options Already a subscriber? Create Account See Subscription Options. They must have the same active ingredient and provide the same benefits.
There are a few differences, however. Generics may have slightly different inactive ingredients fillers, binders, flavors, etc. Many people have concerns about switching to generics and prefer brands. Some doctors also have concerns with certain medications. To be clear, this is a preference. These concerns might include:. There are no laws that restrict the substitution of any FDA-approved generic or brand medication.
You and your doctor can discuss if a brand or generic is the best option for you based on your comfort and budget. If you switch from a brand to a generic, you may need closer monitoring to make sure the medication is suitable for you.
Cost is one of the main reasons a generic is the better choice. Generic medications are a lot less expensive than their brand counterpart. Data indicates the use of low-cost generics improves health outcomes, and one reason is people taking generics are more likely to take their prescribed medications.
Medication affordability is one of the biggest concerns for many Americans today. Doctors sometimes prefer not to switch medications that have a narrow therapeutic index NTI , or safe range. Some examples include blood thinners like warfarin Coumadin , thyroid medications like levothyroxine Synthroid , the heart medication digoxin , medications for epilepsy or seizures.
Again, this is a personal choice between you and your doctor. Be sure to talk with your doctor about your options. Brand medications are new discoveries developed through research and clinical trials. New drugs go through years of testing on animals and humans to prove they are safe and effective before they are ready for us to use. This takes a lot of money so brand companies get patent and exclusivity protection from competition for several years.
The manufacturer of the brand can set any price for that medication to profit from their new discovery. Only after the patent has expired and several generic companies enter the market does price come down, often to less than 20 percent of the brand price through competition.
The best way to understand more about a medication your doctor has prescribed is to speak with your pharmacist. The color, shape, or other traits may be different, but the active ingredient for brands and generics are the same. You can also tell the difference by the name. The generic name is also the active ingredient, like the sedative diazepam for the brand Valium. Some medications are only available as a brand.
But if a medication has a generic version, many states have laws that require pharmacists to switch to a generic when one is available. Keep in mind though, if you have insurance, only the cost of the generic medication may be covered.
Most insurance companies have drug formularies or lists of approved medications. Generic medications are just as safe as brands. They must go through the same testing to show they work before approval by FDA. Brand and generic medications have the same effects. CADTH takes sole responsibility for the final form and content of this document. The views expressed herein are those of CADTH and do not necessarily reflect the views of our funders. Breadcrumb Home. Copied to clipboard. Why is this important to my patients?
One of the key parameters for bioequivalence is the area under the curve AUC. The AUC is a mathematical calculation based on a graph of blood concentration versus time, and it correlates well with total drug exposure. There is international consensus that differences within this range are not clinically significant.
Recall that the confidence interval is a range of measurements within which we can be confident that the true result lies. The product may also be slightly different in colour, shape, or markings. Why do generic drugs cost less? There is usually competition among generic drug manufacturers.
How do I know if a generic drug is safe for my patient? Health Canada must review and approve all drug products before they can be sold in Canada. What makes generic and brand name drugs interchangeable? When might it be unsafe to switch brands? What about critical dose drugs? How do I report an adverse event? Bottom Line: Generic and brand name drugs are bioequivelant.
Clinically important differences have not been reported in well-controlled trials.
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