Are Generic Drugs Equivalent to Brand Name Medications?

Introduction

In 2007, $228 billion dollars was spent on brand name drug products, and $58.5 billion was spent on generic drug products. A generic drug is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its chemical name without advertising. Generic drugs are subject to the regulations of the governments of countries where they are dispensed.

Main Item

Is There a Difference Between a Brand Name Drug and a Generic?

Yes, there are differences:

• Both drugs contain the same active ingredients (the therapeutic, medicinal portion), but the drugs contain different fillers, binders, coloring agents, and flavorings.
• Generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use.

See our List of Generic Equivalents for Brand Name Drugs

When Are Generic Drug Equivalents Released?

The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

For as long as a drug patent lasts, a brand name company enjoys a period of "market exclusivity" or monopoly, in which the company is able to set the price of the drug at a level which maximizes profitability. In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic drugs become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. Companies incur fewer costs in creating generic drugs (only the cost to manufacture, rather than the entire cost of development and testing) and are therefore able to maintain profitability at a lower price. Sometimes reverse-engineering is used to develop bio-equivalent versions to existing drugs. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company.

To gain FDA approval, a generic drug must:

• Have the same use indications
• Be identical in strength, dosage form, and route of administration.
• Meet the same manufacturing batch requirements for identity, strength, purity, and quality.
• Contain the same active ingredients as the brand name drug (inactive ingredients may vary).
• Be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for brand name products.
• Be bio-equivalent, defined by the FDA as the absence of a significant difference in rate and extent absorbed of the active ingredient in the pharmaceutical alternative when administered at the same dose, in similar conditions.

The FDA has cautioned against several classes of drugs that require special consideration when choosing equivalents. These drugs may be therapeutically equivalent; however they may have characteristics which may cause problems in bio-equivalence, such as insolubility in water and pharmacokinetic discrepancies. Specific examples include drugs with critical dose and narrow therapeutic index (warfarin, levothyroxine) characteristics, special release formulations (extended release (ER), delayed release (DR), and bio-engineered protein drugs (insulin, Enbrel).

Generic Drug Facts:

• Generic drugs generally cost 30% to 80% less than its brand-name equivalent and can help save money.
• There are no differences in the quality and safety standards that generic and brand name drug products must meet.
• They meet FDA requirements and have proven that they are just as safe and work the same way in the body as the brand-name products.
• Generic drug products contain the same active ingredient(s), come in the same strength, dosage form and are taken the same way as its brand-name equivalents.
• Generics vary by manufacturer, which means you could receive different versions based on where you purchase your medications and what type of generic they dispense.
• Generic drugs are drug products that contain the same medicinal or therapeutic ingredient(s) as the original brand name drug. Generic and brand name products may look or taste different but both contain the same amount of the same active drug(s). The shape, color and size may be different because generic drug products contain inactive (inert) ingredients or excipients that are different from those used in the brand-name products. These inactive ingredients include: dyes, binders (ingredients used to hold the tablets together), and preservatives. These ingredients do not change the effectiveness of the drug.

Drug companies often change how they market or package their products. It helps to know that:

• Drug products enter and leave the marketplace constantly.
• Many drugs may be available to treat the same medical conditions or symptoms.
• A drug can move from generic to brand status - or brand to generic status - without warning.
• Certain forms or dosage amounts of drugs may be available as a generic, while others are not. For example, a tablet form of a drug may be available as a generic but not the liquid form; or a 1 mg tablet may be available as a generic, but the 5 mg version is only offered as a brand.

Insurance and Generic Drugs:

For most consumers, their insurance plan determines what they pay for medication.

Both private and government insurance companies promote using generic drugs when possible. They might even require substituting a generic for a brand name drug.

The co-pay for the generic might be $10. But the co-pay for the same dosage and amount of the brand name might be $40.

Some insurance plans might require you to pay the entire cost of the brand name drug if you don't accept the available generic.

Why doesn't my doctor prescribe generic drugs?

• Not all medications have a generic form available.
• Some doctors might not be aware of recently approved generics.
• Different states have different laws and regulations on generic substitutions.
• Doctors differ in their beliefs towards, and experiences with, different medications.

If you're interested in trying a generic drug, first find out if it's available. Ask your doctor. Also, your pharmacist will have a list of generic drugs and can usually tell you how much they will cost on your insurance plan.

In some cases, it is unwise to switch from a brand name med to its generic form. There are certain drugs that have a narrow therapeutic index (NTI). With this group of drugs, if you switch to a generic form, you may compromise the availability of active drug in your system.

If you decide to buy generic, have your doctor choose a drug with an identical format as the brand name and not with merely the same active ingredient. The generic should mimic the entire original drug.

Related Information

• List of Generic Equivalents for Brand Name Drugs : List of brand name drugs and their Generic Equivalents sorted alphabetically by brand name and generic substitute - Disabled World
• List of Benzodiazepines: Types and Medicinal Use : Explanation of Benzodiazepines (Benzos) including a list of common Benzodiazepine brand and other names, their medical purpose and uses - Disabled World
• FDA Issues Guidance on Generic Abuse-Deterrent Opioid Development : Statement from FDA Commissioner Scott Gottlieb M.D. on steps to promote development of generic versions of opioids formulated to deter abuse - U.S. FDA

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Cite This Page (APA): Langtree, I. C. (2011, September 14 - Last revised: 2024, August 23). Are Generic Drugs Equivalent to Brand Name Medications?. Disabled World. Retrieved October 5, 2024 from www.disabled-world.com/medical/pharmaceutical/generics.php

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