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Generic Drugs

Generic Drugs

From the Texas State Board of Pharmacy

What is a generic drug?

A generic drug is a copy of a brand name drug whose patent has expired. The original manufacturer of a drug receives a patent on the drug and is the only manufacturer who can produce and sell the drug during this patent period. Once the patent expires, other manufacturers may produce and sell the drug. These manufacturers usually sell the drug under its common or generic name.

Most drugs have three names:

  • a chemical name
  • a generic name
  • a brand name

Since chemical names are usually long and complicated, the drugs are given a standard, shorter generic name. Manufacturers will usually give drugs brand names to identify that manufacturer's version of the product. An example of these three names, using a well known prescription drug is as follows:

  • chemical name 7-chloro-1,3-dihydro-1- methyl-5-phenyl-2H-1,4-benzodiazepin-2-one;
  • generic name diazepam; and
  • brand name Valium.


Who makes generic drugs?

There are many manufacturers of generic drugs in the United States. Some of these companies make only generic drugs, and some are divisions of major companies which also produce brand name drugs.


Why do generic drugs cost less than brand name drugs?

A large portion of the cost of brand name drugs covers the high cost of research and development. Generic manufacturers do not have to duplicate the cost of research and marketing conducted by the original manufacturer. Therefore, the cost of the generic drug is usually less.


Are generic drugs as reliable as the brand name product?

All drugs considered to be generically equivalent to a brand name product must meet strict manufacturing requirements set by the Federal Food and Drug Administration (FDA). These requirements include tests which assure that the product is bioequivalent to the brand name product. Bioequivalent means that the same amount of active ingredient is delivered to the body at the same time, and used by the body, in the same way as the brand name product. Therefore, generically bioequivalent drugs should produce the same results as the brand name product.


How do I know if my pharmacist used a generic drug on my prescription?

Texas law requires the pharmacist to indicate that a generic drug has been substituted for a brand name drug by placing on the container the statement, "Substituted for Brand Prescribed," or "Substituted for Brand Name," where Brand Name is the actual name of the brand name product prescribed, e.g., "Substituted for Valium." If you have a question about a specific prescription, ask your pharmacist.


How do I request that my prescriptions be issued for generic drugs?

Ask your doctor to indicate on your prescription that a generic drug may be used.


Do I have a choice? Can I ask the pharmacist NOT to substitute a generic drug for a brand name drug on my prescription?

Yes, you have the right to refuse a generic substitution. The pharmacist must then dispense the brand name drug.

You should be aware, however, that some insurance companies or state aid programs will not pay, or will pay less, for a prescription if a brand name drug is used. In this situation, you may have to pay the cost of the brand name drug or a higher co-payment if you want the brand name drug.




 

 
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