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What makes a drug “generic” and is it right for me?

You can save big on generic drugs – 30-60 percent. But are they as good as the brand name and why are they so much cheaper?

About 75 percent of brand-name, FDA-approved prescription drugs have generic-drug versions. In fact, more than half of all US prescriptions — more than 1 billion a year — are for generics.

Are generic drugs the same as a brand name drug?
The Food and Drug Administration requires that all drugs it approves, brand name and generic, be safe and effective and that their benefits outweigh their risks.

A generic drug must be “bioequivalent” to a brand-name drug: its active ingredient must work in the same way and in the same amount of time. Generic companies must prove that their products follow the same quality manufacturing standards, and have similar labeling.

The FDA does, however, allow generic drugs a 21 percent difference in formula. For some patients, the differences can mean that generics are not always as effective, or may have different side effects.

Should I use the generic?
When you’re beginning or changing medication therapy, talk to your doctor and your pharmacist about your options. With psychiatric medications, it can take a great deal of trial and error to find an effective balance. If you’re doing well on your current medication, you and your doctor may decide not to make a switch from a brand name to a generic.

In rare cases, when switching from a brand name to a generic, your doctor may want to monitor you as your body adjusts to the switch.

What makes a drug generic?
Generic drugs are copies of drugs that have been in use for many years, most for a decade or more. Over the years, they’ve proven to be safe and effective. New drugs, while they’ve undergone years-long studies involving thousands of people, are now being introduced to millions of people.

Manufacturers of generic drugs can market them at a lower price because the nearly $900 million it costs to bring a drug to market has already been invested by the original manufacturer.

Development costs include the research necessary to gain FDA approval. Makers of generics are not required to repeat the original research, rather they must prove to the FDA that their drugs are bioequivalent to the brand-name drug.

Patent protection gives brand-name companies the sole right to sell a drug for a certain period of time. This allows them to fairly recoup their investment costs. Patent protection for a drug typically lasts an average of 11 years. A generic drug can enter the market only after the brand-name patent or other marketing exclusivities have expired and FDA approval is granted.

Generics wouldn’t exist without the investment made by the original manufacturers, which achieved the development and reaped profits that exceeded its cost.

A number of drug patents approved 10-15 years ago will be expiring soon allowing manufacturers to begin marketing generic versions.

How much can I save?
The average price for a prescription for a brand-name drug is $84.20, while the average price for a generic drug prescription is $30.56, according to the National Association of Chain Drugstores. Check your insurance plans; you may have lower co-pays for generic medications. Pharmacists set their own prices on generic drugs which vary widely from one pharmacy to the next. You can save money by shopping around.

In some cases, generics can cost a fraction of the brand name version. For example, from some pharmacies, a month’s worth of Celexa, 20 mg, is about $100; Target offers the generic (citalopram), for $4.00. Walgreens, Costco and Walmart also have discount programs.

Does my medication have
a generic version?

Your pharmacist can tell you.

Sources
FDA The FDA’s Office of Generic Drugs
Journal of the American Academy Family Physicians.

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