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the difference between generic drug and generic name

Source: Food and Drug Administration (FDA)

The generic name is created every time a pharmaceutical company creates a new drug. Then, the company creates a brand name in order to market the drug using the brand name. Also, the company gets a patent in order to protect the drug from being copied by other companies. The term of the patent begins on the date on which the patent is issued and ends 20 years from the date on which the application for the patent was filed.

The generic name identifies a drug substance, that is, the active ingredient. For example, loratadine is a generic name. In other words, loratadine is the active ingredient of drugs that relieve allergy symptoms.

The brand name is the name used by the manufacturing company to market the drug. For example, Claritin is a brand name. In other words, the manufacturing company uses the brand name Claritin to market the drug, which contains the active ingredient loratadine.

After the patent expires, the drug becomes a generic drug. In other words, a generic drug is a copy of the brand-name drug whose active ingredient lost its patent protection. The patent for the active ingredient has expired. For example, the active ingredient loratadine lost its patent protection some years ago. It is, now, marketed by some companies under its own generic name loratadine. On the other hand, Claritin is and will always be called a brand-name drug.

Another example, the active ingredient diltiazem lost its patent protection some years ago. It is, now, marketed by some companies under its own generic name diltiazem and by other companies under brand names such as Cartia or Taztia.

A generic drug must have the same active ingredients, dosage form, safety, strength, route of administration, and intended use as the brand-name drug. In other words, the generic drug must be therapeutically equivalent to the brand-name drug.

Generic drugs may have different size, color, flavor, shape, or inactive ingredients from the brand-name drugs. Trademark laws in the United States do not allow the generic drugs to look exactly like the brand-name drugs, but the active ingredients must be the same in both drug preparations, ensuring that both drugs have the same medicinal effects.

The bottom line about FDA-approved generic drugs is that the active ingredient of generic drugs has no patent.

Examples of brand-name drugs:
-- Celebrex is a brand name and celecoxib is a generic name. The Food and Drug Administration (FDA) approved Celebrex as a brand-name drug because the manufacturing company demonstrated to the FDA that this drug had unique pharmacological and therapeutic characteristics. As a result, this drug was granted several patents and, thus, the manufacturing company has been the only company making and selling this drug. The active ingredient of this drug is identified by the generic name celecoxib and, because of the patents, celecoxib is not a generic drug. The patent for the active ingredient celecoxib will expire in November 2013 and, then, celecoxib will become a generic drug in December 2013. But, Celebrex is and will always be called a brand-name drug.

-- Zocor is a brand name and simvastatin is a generic name. The Food and Drug Administration (FDA) approved Zocor as a brand-name drug because the manufacturing company demonstrated to the FDA that this drug had unique pharmacological and therapeutic characteristics. As a result, this drug was granted several patents and, for about 20 years, the manufacturing company had been the only company making and selling this drug. The active ingredient of this drug is identified by the generic name simvastatin. The patent for the active ingredient simvastatin expired in July 2006 and, now, simvastatin is a generic drug. But, Zocor is and will always be called a brand-name drug.

Examples of generic drugs:
-- the generic drug Albuterol consists of the active ingredient albuterol and the manufacturing company has decided to market the drug using the generic name albuterol itself.
-- the generic drug Diltiazem consists of the active ingredient diltiazem and the manufacturing company has decided to market the drug using the generic name diltiazem itself.
-- the generic drug Cartia consists of the active ingredient diltiazem and the manufacturing company has decided to market the drug using the brand name Cartia.
-- the generic drug Erythromycin consists of the active ingredient erythromycin and the manufacturing company has decided to market the drug using the generic name erythromycin itself.
-- the generic drug EryDerm consists of the active ingredient erythromycin and the manufacturing company has decided to market the drug using the brand name EryDerm.

On the other hand, it is worth noting that Cardizem CD and Cartia XT are brand names, but Cardizem CD is a brand-name drug while Cartia XT is a generic drug. In fact, Cartia XT is the generic equivalent to Cardizem CD. The Food and Drug Administration (FDA) approved Cardizem CD as a brand-name drug and approved Cartia XT as a generic drug.

What is PATENT?
Patent is the right to exclude others from making, using, or selling an invention or product. The term of the patent begins on the date on which the patent is issued and ends 20 years from the date on which the application for the patent was filed. Patents are granted and issued by the U.S. Patent and Trademark Office at the U.S. Department of Commerce.





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