TRUTH ABOUT GENERIC DRUG

Recently there has been a lot of talk, and plenty of confusion, about generic drugs. What are they? Why are they different? Can you benefit from their use?

A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection (The generic drug may still have a patent on the formulation but not on the active ingredient). A generic must contain the same active ingredients as the original formulation.. Thus a generic drug is simply a branded drug that uses a different name. You’ll recognize many of the names. The brand Viagra has a generic called Generic Viagra (Sildenafil Citrate) which helps men to treat Erectile Dysfunction. Prilosec is the brand name for generic omeprazole, which helps people with reflux disease. Metformin, used by diabetes patients, is the generic name for the brand Glucophage.

The U.S. Food and Drug Administration considers a generic drug to be “identical, or bioequivalent, to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

Generic drugs cost less than their branded counterparts, and that’s why we’re hearing so much about them.

Why do generic drugs cost less?

Actually, generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug. When a company brings a new drug onto the market, the firm has already spent substantial money on research, development, marketing and promotion of the drug. When a pharmaceutical manufacturer develops a new drug, it obtains a patent, which protects the manufacturer’s investment in developing the drug. No one else can legally sell the exact drug for a period of time, usually 17 years.

That patent-protected drug is the branded drug, and when we pay for it, we are also paying for the research costs, the costs incurred in proving it is safe, the costs to market and transport the drug, so the patent protected drug is higher in costs..

As the patent nears expiration, other manufacturers can apply to the FDA for permission to make and sell generic versions of the drug. Without the startup costs for development of the drug, other companies can afford to make and sell it more cheaply. When multiple companies begin producing and selling a drug, the competition among them can also drive the price down even further.

If the generic drug is equivalent, then why wouldn’t we always choose to use the generic instead of the branded version?

Not all branded drugs have a generic version. Most recently developed drugs will still fall within the patent-protected time. To get the benefits of those drugs, you’ll need to use the branded versions.

Also, “bioequivalent” means only that the active ingredients need to be the same. U.S. trademark laws require the drugs to look different, so the generic version may be a different color, a different shape, have a different taste, or contain inactive ingredients that are different.

If you have an insurance plan that covers prescription drugs, you may be surprised to know that some branded drugs will actually cost you less than generics do. Health insurance companies negotiate pricing with drug manufacturers and drug sellers, which occasionally results in more-favorable pricing for branded drugs.

Your insurance company maintains a list of preferred drugs, called a formulary, that helps you understand pricing. If the choice is not clear, check with your insurance company to determine whether the branded or the generic will cost less.

The best way to be sure you are getting exactly the drug you need, branded or generic, is to consult with your doctor. When your doctor prescribes a drug, ask if there is a generic equivalent. If there is, then ask which form of the drug makes the most sense for you.

Want to know more about generics?

The FDA maintains the Orange Book, a reference guide about the availability of generic versions of drugs. One can search there for the quality related to generic drugs. All the generic versions of branded drugs are approved by FDA as FDA requires that all drugs be safe and effective and that their benefits outweigh their risks. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risk-benefit profile as their brand-name counterparts.