Generic drugs are just as good as brand name drugs. They both have the same ingredients, and they work the same way in your body.
The only difference is that generic drugs cost less money. Generic drugs are cheaper because the drug companies that make them don’t have to spend money on advertising and marketing. They also don’t have to pay for patents or research and development costs.
What are Generic Drugs?
An authorized generic drug is a precise replication of a brand-name version authorized by the patent holders who originally owned the pharmaceutical product. The generic name product should be bioequivalent to the original branded product.
Once a generic medication is available in a market, competition usually results in a significantly lower price of both the original brand name product and the generic equivalent. In most cases, generic products are made available once the patent protections granted to a drugs original developer have expired. New drugs are protected by patents against being manufactured by other companies as generics.
Drug research is expensive, and the patent protection gives the manufacturer of the brand-name medicine at least 20 years to recover that expenses- costs not available to the generic maker.
Like the brand-name drug, a generic drug must have the approval of the FDA, but a company producing generic versions of the drug is able to sell it at a price far lower than that of a brand-name drug because it has not spent money on research and clinical trials. Other manufacturers typically market a drug by its generic or common name. While drugs can have a variety of brand names, a generic name describes the drug’s active ingredients, and is one way of identifying a drug’s type.
Because the active ingredient is what FDA is specific about, inactive ingredients of generic and brand-name drugs are different. There is also a category of generics called authorized generics, which are similar in nearly every way (e.g., size, shape, color, taste, smell, active and inactive ingredients) to brand-name drugs. Trade laws prohibit generic drugs from looking exactly like brand-name drugs, but they all have the same active ingredients that produce the same medical effects.
Generic drugs can vary from brand-name drugs in terms of colors and flavors, among other things, and the FDA wants to make sure they do not impact how a drug works. When a generic drug is first approved and sold, costs can stay high (although lower than a brand-name drug) for 6 months, as the FDA gives the first generic maker 180 days exclusivity. When the patents or other periods of exclusivity have expired, other manufacturers can file a Shortcut New Drug Application (ANDA) with FDA to get approval to sell the generic version of a brand-name drug.
Brand-name generics, in contrast, are defined by FDA and NHs as products that are either (a) new formulations of non-patented products manufactured by a manufacturer who is not the molecule developer, or (b) copies of molecule from non-patented products that have commercial names.
What are “Branded” Generic Drugs?
Branded generics are defined as either newer formulations of drugs that have lost patent protection and were not developed by a company marketing the generic, or as merely a generic medication given a brand name.
Some branded generics are specifically made as new formulations of drugs off-patent, addressing the gap in dosing, while giving consumers a name they are more likely to remember than a real generic. Because branded generics are not subject to patents, a number of drug companies are free to compete on the market for sales of these drugs. Manufacturers advantages in name recognition and higher prices suggest branded generics will remain a part of the overall generics market in the long run.
Some branded generics are specifically made to be novel dosage forms of drugs that are not covered by a patent, thereby filling the dosage gap, but also offering consumers a name that is probably easier to remember than a real generics name. Many drugs introduced by generic manufacturers have been on the market for a decade or more, and they are probably well known by patients and providers, though usually by their brand names.
What are “Authorised” Generic Drugs?
An authorized generic is sold on the basis of the new Drug Application (NDA) for a brand-name medicine, and is thus not listed on the FDAs Approved Drug Products for Treatment Equivalence Assessment (the Orange Book).
The price points are generally lower than their brand-name products, but they may not be as low as generics approved via an abbreviated NDA pathway by a different sponsor.
All generics function the same and offer the same clinical benefits as the brand-name versions, but, unlike other generics, authorized generics are typically made at the same manufacturing facilities as brand-name drugs.
Standard generics generally are not available until the brand patents expire and another manufacturer has created an alternative. All drugs–traditional generics, authorized generics, and branded drugs – must conform to the same standards for quality and manufacturing established by the Food and Drug Administration. This strategy allows manufacturers to take advantage of authorized generics, which have larger list prices, which lessens the pressure for lower prices on prescription drugs.
What Is The Difference Between Brand Name And Generic Drugs?
The FDA tests generic drugs to ensure they provide the same benefits as the name brand medicine, and to ensure any different ingredients used in a generic medication are safe. Basically, the FDA makes sure a generic drug has the same active ingredients, the same amounts, and does the same work as a brand-name product before they are allowed to be used as an alternative.
To make this determination, a generic drugs manufacturers have to make sure the drugs they are making have the same active ingredients (s) as the brand name product, the same form of drug, at the same dosage or concentration, and the same route of delivery (e.g., amoxicillin 500 milligram capsules (oral)). Because of these differences, generic drug manufacturers are required to file extra paperwork to FDA proving their products are manufactured according to Good Manufacturing Practices (GMPs) and are as pure and stable as the brand-name product.
Generic medications generally (but not always) cost a lot less than their brand-name counterparts, since they do not need to go through the costly studies and clinical trials that brand-name medications go through to prove that they are safe and effective.
Because of the perceptions or previous experiences of generic medications, some consumers will continue using the brand-name medications in spite of this cost variation, potentially leading to increased costs to consumers, dissatisfaction among patients, and eventually decreased compliance.
Although some characteristics, such as the inactive ingredients, can vary, for the FDA to approve a generic drug, differences between branded and generic drugs cannot impact the characteristics of the product, its safety, or its efficacy. The FDA believes that a medication product is comparable when it meets its criteria of therapeutic equivalence, even though the generic medication might differ in some other characteristics (such as form, taste, or preservatives).
Are Generic Drugs As Safe As Brand Name drugs?
All drugs, brand or generic, approved by the U.S. Food and Drug Administration must meet the same high standards of quality, strength, purity and stability
Basically, the FDA makes sure the generic medication contains the same active ingredients, the same amounts, and does the same work as the brand-name product before it can be used as a substitute.
Because the FDA is specific about active ingredients, inactive ingredients of generic drugs differ from those of brand-name drugs.
Are Generic Drugs Cheaper And Why?
Generic drug manufacturers are able both to develop and market a generic medication for much lower costs, not because generics are lower-quality than the name-brand drugs, but because the original manufacturers already paid most of the costs for discovering and developing a prescription drug from scratch.
Second, although brand name drugs are sold only by a single manufacturer, multiple companies usually will market the same generic medication, leading to market competition and lower costs for consumers.
When the generic is first approved and sold, costs can stay high (although less expensive than that of the brand-name drug) for 6 months, as the FDA gives the first generic maker an exclusive period of 180 days.
When the patents or other periods of exclusivity have expired, other manufacturers can file a Shortcut New Drug Application (ANDA) with FDA to get approval to sell the generic version of a brand-name drug.
When a generic drug application is submitted, the FDA thoroughly reviews the data submitted by the applicant and assesses the information obtained by FDA investigators during inspections of related manufacturing testing and facilities to assure that each generic medication is safe, effective, of high quality, and comparable in performance to the brand name medication.
According to the Kaiser Family Foundation, a health-research organization, there are about three-quarters of all drugs approved by the FDA that have generic versions, which generally cost 13-94% of their brands prices, depending on how many companies make them.
Why Do Generic And Brand Drugs Look Different?
Trademark laws do not allow generic drugs to look exactly like the name brand (for example, pills may have a different color), but the drugs active ingredients are the same, and they are of equal potency, stability, and purity to their brand-name counterparts.
Although the active ingredients should be the same as in the brand name product, generics can include different inactive ingredients, such as preservatives or fillers.
Does Every Medication Have a Generic Equivalent?
The answer to this question is both yes and no. There are some drugs out there that do not have a generic counterpart, but for the most part, most brand name drugs do have a corresponding generic drug. The reason for this is because when a new drug comes onto the market, the patent on that particular drug expires after 20 years. This means that other companies can then create their own version of the same medication (but with different branding) and sell it at a lower price point.