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- Nonproprietary as an adjective is lacking proprietary value; not private or privileged information. while Generic as an adjective is very comprehensive; pertaining or appropriate to large classes or groups as opposed to specific
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Are generic drugs the same as brand-name drugs?
What is a generic drug?
Are generic drugs cheaper than brand-name drugs?
What is a non-proprietary name for a drug?
Feb 21, 2023 · Every medication has at least three names: a chemical name, a generic name, and a brand name. Several organizations are involved in naming medications. Pharmaceutical companies, the FDA, and the U.S. Adopted Names Council are three key examples. Medication names have to follow many rules, and this can make them sound complex.
- Overview
- What are generic drugs?
- Are generic drugs always safe to take?
- Risks of online pharmacies selling misbranded medications
- Is there a difference between a generic and name-brand version of a drug?
- Are there times when a generic drug is a better choice?
- Are there times when a brand-name drug is a better choice?
- Why do brand-name drugs cost so much more than generics?
- How can I tell if my medication is generic or name brand?
- Who decides if I get brand-name drugs or generics when I get a prescription filled?
Most Americans are unhappy about the cost of drug prices.
In 2016, the U.S. spent $450 billion on prescription drug costs, and spending is projected to increase to $610 billion by 2021.
Even though 90 percent of prescriptions filled in the U.S. are for generic medications, brand-name medications account for 74 percent of spending on medications in the U.S.
Generics save Americans billions every year. In fact, generics saved U.S. consumers $253 billion in 2017 and over $1 trillion in the past decade.
In this article you’ll learn about the main differences between generic and brand-name medications.
Fast facts: generic and brand-name medications
Generic medications are a chemical copy of the original brand, with the same active ingredients. Generics are also available at a lower cost than brand-name medications. In fact, generic drugs cost 85 percent less than the brand version on average.
FDA gives patent and exclusivity protection to brand manufacturers to allow them to profit from their innovation and research for several years. During this time, no generics can compete with the brand.
Once the patent has expired, generics can enter the market through a shortened FDA approval process. Generic medications need to meet the same quality, safety, and effectiveness standards as brands.
Most active pharmaceutical ingredients (API) and generic medications are made outside the U.S. in countries like China, India, and various other countries.
Yes. Generic medications must meet the same quality standards for approval by the FDA as brand-name medications.
Generics have to prove they are bioequivalent to the brand version. Bioequivalence means the generic works the same way and provides the same benefits.
It’s the FDA’s job to monitor drug safety. They inspect over 3000 drug manufacturer facilities around the globe every year. The FDA also monitors generic medication safety after drug approval.
If the FDA discovers problems with safety or quality, a recall is issued for the affected medication to keep the public safe.
For example, if there are reports of a medication causing side effects, or adverse reactions, FDA investigates and acts when needed.
You may have heard about different blood pressure medications being recalled, as well as and the heartburn medication Zantac. These medications had trace amounts of cancer-causing impurities.
A bigger concern with medication safety is purchasing treatments from unsafe online pharmacies. Many online pharmacies sell unapproved brand and generic medications directly to consumers without a doctor’s prescription.
For example, FDA sent a warning letter to Global Drug Supply which operated Canadadrugs.com, for selling many misbranded and unapproved new drugs.
Some examples of medications sold by potentially unsafe online pharmacies include:
•birth control pills
•antidepressants
•finasteride (Proscar), for an enlarged prostate
Generic medications go through testing for quality, strength, purity, and potency to show effectiveness before approval by FDA. They must have the same active ingredient and provide the same benefits.
There are a few differences, however. Generic and brand medications don’t look the same. Generics may have slightly different inactive ingredients (fillers, binders, flavors, etc.). These don’t affect how the medicine works.
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:
•worsening of symptoms or condition
•side effects
•adverse reactions
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. A recent Kaiser Family Foundation survey found 79 percent of people surveyed said drug prices were “unreasonable.”
If you don’t have insurance, cost may be a big reason a generic medication could be a better option.
In some cases, you may need to take a brand-name medication if there’s no generic available.
You may also need to stay with a brand-name if you didn’t respond to the generic, your symptoms got worse, or you had an allergic reaction or side effect from an inactive ingredient.
Doctors sometimes prefer not to switch medications that have a narrow therapeutic index (NTI), or safe range. This means there’s a smaller window between the benefits and the harmful effects of the drug.
Doctors do regular blood tests to make sure you’re in the safe window. Some examples include blood thinners like warfarin (Coumadin), thyroid medications like levothyroxine (Synthroid), the heart medication digoxin, medications for epilepsy or seizures.
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.
The best way to understand more about a medication your doctor has prescribed is to speak with your pharmacist. Brands and generics don’t look alike because brands have trademark protection.
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.
You can also check with FDA’s website to see if a medication has a generic at Drugs@FDA by entering the name of the medication.
You can check the “Orange Book” by searching under the brand name or the active ingredient.
Rules about switching to generic drugs
•In most states, pharmacy staff must notify you about switching to the generic. •Your doctor can write “do not substitute,” “dispense as written,” or “brand medically necessary” to avoid generic switching. •You can refuse a generic substitution. 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.
Apr 13, 2021 · The World Health Organization assigns international nonproprietary names (INN), also known as common names, to compounds upon request from drug developers. Structures of INNs are publicly available and represent a source, albeit underused, to understand trends in drug research and development.
- Marta Serafini, Sarah Cargnin, Alberto Massarotti, Gian Cesare Tron, Tracey Pirali, Armando A Genazz...
- 2021
Some experts find generic names more confusing than brand names. Consider this: The most common generic names (35% of them) end in - ne, averaging 14.4 letters and 5 syllables. The most common proprietary ending (- in) is shared by only 5% of proprietary names, which average 10.4 letters and 3.53 syllables. 3.
- Jeannette Y. Wick
- 2004
Oct 5, 2022 · Differences. Approval process. Switching between the two. Effectiveness. Generic version availability. Cost difference. Medicare coverage. What is the difference between generic and brand-name...
Mar 16, 2021 · A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics,...
Jul 21, 2022 · While generics must be made from the same active ingredient (s) and meet the same standards for safety, quality, strength, purity and efficacy as brand-name drugs, there are differences. Appearance. They look different. Trademark laws require that generics look different than the brand drug. They may be different in color, shape and/or size.
