Difference Between Generic And Brand Name Drugs Pdf
File Name: difference between generic and brand name drugs .zip
Understanding the differences between generic and brand name medications can help injured workers understand their workers' compensation prescriptions a bit better.
- How the FDA Ensures High-Quality Generic Drugs
- What's the difference between brand-name and generic prescription drugs?
- Generic drug
- Sample List of Brand Drugs and Their Generic Equivalents
Physician acceptance of generic drugs and, by extension, patient acceptance and medication adherence depend largely on trust that generic drugs adhere to strict standards to gain approval from the U. When a patient picks up a prescription at a pharmacy and receives a generic medication, FDA approval ensures that the generic drug works the same as the brand name drug. Although the FDA does not require comparative outcome studies for generic approval, multiple studies have demonstrated that generic drugs are equally effective as their brand counterparts i.
How the FDA Ensures High-Quality Generic Drugs
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, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine.
In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart. Generic Drug Facts At-a-glance information on generic medicines, including why they may look different or cost less than brand-name medicines. This standard applies to all generic medicines. Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines.
A generic drug may have certain minor differences from the brand-name product, such as different inactive ingredients. It is important to note that there will always be a slight, but not medically significant, level of expected variability—just as there is for one batch of brand-name medicine compared with the next batch of brand-name product. This variability can and does occur during manufacturing, for both brand-name and generic medicines. When a medicine, generic or brand-name, is mass produced, very small variations in purity, size, strength, and other parameters are permitted.
FDA limits how much variability is acceptable. Some generics were absorbed slightly more, some slightly less. This amount of difference is expected and clinically acceptable, whether for one batch of brand-name medicine tested against another batch of the same brand, or for a generic tested against a brand-name medicine.
Research study: Clinical equivalence of generic and brand-name drugs used in cardiovascular disease A study of 38 published clinical trials showed no evidence that brand-name heart medicines worked any better than generic heart medicines. Generic medicines and brand-name medicines share the same active ingredient, but other characteristics, such as colors and flavorings, that do not affect the performance, safety, or effectiveness of the generic medicine, may be different.
Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug.
Generic drugs tend to cost less than their brand-name counterparts because generic drug applicants do not have to repeat animal and clinical human studies that were required of the brand-name medicines to demonstrate safety and effectiveness. When multiple generic companies are approved to market a single product, more competition exists in the marketplace, which typically results in lower prices for patients.
In , FDA announced the Drug Competition Action Plan DCAP to further encourage robust and timely market competition for generic drugs and help bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program. FDA reviews the application to ensure drug companies have demonstrated that the generic medicine can be substituted for the brand-name medicine that it copies.
The ANDA process does not, however, require the drug applicant to repeat costly animal and clinical human studies on ingredients or dosage forms already approved for safety and effectiveness. This allows generic medicines to be brought to market more quickly and at lower cost, allowing for increased access to medications by the public. Detailed information on the critical factors the FDA reviews to make sure a generic medicine is as safe and effective as the brand-name drug. FDA takes several actions to ensure safety and quality before and after a new or generic medicine is approved.
When a generic drug application is submitted, FDA conducts a thorough examination of the data submitted by the applicant and evaluates information obtained by FDA investigators while inspecting the related testing and manufacturing facilities to ensure that every generic drug is safe, effective, high quality, and substitutable to the brand name drug.
FDA also monitors and investigates reports of negative patient side effects or other reactions. The investigations may lead to changes in how a product brand-name and generic is used or manufactured, and FDA will make recommendations to health care professionals and the public if the need arises.
Contact your doctor, pharmacist, or other health care provider for information on generic medicines. For more information, you can also:. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother.
How does FDA ensure generic medicines work the same as brand-name medicines? Why do generic medicines often cost less than the brand?
What standards must generic medicines meet to receive FDA approval? How does FDA monitor side effects or safety issues with generic medicines? Where can I find more information about generic medicines? What are generic drugs? Additional Resource. Additional Resources.
What's the difference between brand-name and generic prescription drugs?
A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. A generic medicine works in the same way and provides the same clinical benefit as its brand-name version. This standard applies to all FDA-approved generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used. Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines.
You've no doubt seen them in the grocery store — typically drab-looking packages on the bottom shelf containing lower-priced generic versions of popular brand-name products. Some shoppers look at them with skepticism: Are they really as good? Or does cheaper just mean lower quality? Many people have the same questions about generic prescription medications, says Dr.
A brand-name drug product is originally discovered and developed by a pharmaceutical company. In this documentation the company submits data to establish a drug's clinical safety and efficacy. Other studies determine the characteristics of the drug dosage form, including the manufacturing process, drug stability, purity, strength, and how it dissolves. Once the drug receives FDA approval, the innovator company can then exclusively market and sell this 'brand-name' product for as long as the company has patent protection. A patent allows the innovator to sell its product exclusively in order to recoup money spent during development and to generate a profit.
Sample List of Brand Drugs and Their Generic Equivalents
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. Although they may not be associated with a particular company, generic drugs are usually subject to government regulations in the countries in which they are dispensed. A generic drug must contain the same active ingredients as the original brand-name formulation. The U. Food and Drug Administration FDA requires generics to be identical to or within an acceptable bioequivalent range of their brand-name counterparts, with respect to pharmacokinetic and pharmacodynamic properties.
Buying more generic prescription drugs instead of their brand-name equivalents and purchasing brand-name drugs with discounts can significantly reduce overall prescription drug expenditures. Generic Drugs. The federal Food and Drug Administration FDA , which approves all products, certifies the "safety and suitability of generic drugs and encourages their use. Brand-Name Drugs.
A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, Generic Drug Facts Handout (PDF KB).
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