Generic Drugs Facts and Myths

WHAT IS A GENERIC DRUG?

A generic drug is one which is identified by its official chemical namerather than an advertised brand name.¹ The term has also come to mean a drug that has been introduced onto the market, usually after the patent on the brand-name drug has expired.

• A typical pharmaceutical patent is 7 years

¹Brand Name Drug: A brand name drug is a drug marketed under a proprietary, trademark-protected name.

History

Passage of Drug Price Competition and Patent Term Restoration Act of 1984 extended eligibility for abbreviated new drug application (ANDA) processing to drugs first marketed after 1962, making generic versions of brand name drugs possible when any patent or period of exclusivity expired. The ANDA process does not require the sponsor to repeat costly clinical and animal research on active ingredients or finished dosage forms already found to be safe and effective, making economically feasible the marketing of generic versions of products approved after 1962.

Difference between brand and generic brand name products

• The active ingredients² in the brand-name and generic products are the same.
• Both the brand-name and the generic versions must have the same potency, be available in the same dosage forms³,how it is taken, quality, performance, demonstrated safe and effective, and be manufactured undergovernment-approved Good Manufacturing Practices (GMP).
• Before approving a generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The FDA bases evaluations of substitutability, or "therapeutic equivalence," of generic drugs on scientific evaluations

²Active Ingredients: An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.
³Dosage Form: A dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable.

• The inactive ingredients such as fillers and dyes are allowed to be different, theseingredients should not affect the safety or efficacy of a drug inany way.

If they're made the same way as brand-name drugs,why do generic drugs cost less?

1. The generic pharmaceutical do not spend much time in research and development.
2. It cost a fortune to develop a new drug.
3. But reward of developing a new drug is that the company that develops a new drug, set the price of the medication (usually depending on their cost of research and development and naturally, supply and demand.

Generic drugs may have different tablet formulation than brand name drugs

• In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.

FDA assertion regarding generic drugs

• FDA ensures that your generic drug is safe and effective. All generic drugs are put through a rigorous, multi-step approval process. From quality and performance to manufacturing and labeling, everything must meet FDA's high standards. We make it tough to become a generic drug in America so it's easy for you to feel confident.
• reference
  http://www.fda.gov/cder/consumerinfo/generic_info/generic_anxiety.htm

Editorial Note:

Every generic drug have a equivalency rating.
(Added: 19-Oct-2005 Rating: 10.00 Votes: 1) Rate It
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