What is a brand name drug?
Every business has the right to promote its brand. After a pharmaceutical company develops a drug, that drug is granted a 20-year patent, which means that no other company can make it for the entire duration of the patent. When the drug is approved by FDA, it is given a generic (official) name and trade (proprietary or brand) name. Brand name medication can only be produced and sold by the company that holds the patent for the drug.
Usually, about 10 years elapse between the time a drug is discovered (when the patent is obtained) and the time the drug is approved for human use, leaving the company only about half of the patent time to exclusively market a new drug. Without fair compensation from meaningful patent protection, drug research and development would slow or stop.
What are generic medications?
When the patent of a brand name medication expires, other companies may produce and sell a generic version of the drug. All generic drugs must be reviewed and approved by the FDA before they can be marketed.
FDA requirements for generic drugs:
* Generic drugs must have the same active ingredients and the same labeled strength as the brand-name product.
* Generic drugs must have the same dosage form (for example, tablets, liquids) and must be administered in the same way.
* Generic drug manufacturers must show that a generic drug is bioequivalent to the brand-name drug, which means the generic version delivers the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the brand-name drug.
* Generic drug labeling must be essentially the same as the labeling of the brand-name drug.
* Generic drug manufacturers must fully document the generic drug’s chemistry, manufacturing steps, and quality control measures.
* Firms must assure the FDA that the raw materials and finished product meet specifications of the U.S. Pharmacopoeia, the organization that sets standards for drug purity in the United States.
* Firms must show that a generic drug will remain potent and unchanged until the expiration date on the label.
* Firms must comply with federal regulations for good manufacturing practices and provide the FDA a full description of facilities they use to manufacture, process, test, package, and label the drug. The FDA inspects manufacturing facilities to ensure compliance.
Every business has the right to promote its brand. After a pharmaceutical company develops a drug, that drug is granted a 20-year patent, which means that no other company can make it for the entire duration of the patent. When the drug is approved by FDA, it is given a generic (official) name and trade (proprietary or brand) name. Brand name medication can only be produced and sold by the company that holds the patent for the drug.
Usually, about 10 years elapse between the time a drug is discovered (when the patent is obtained) and the time the drug is approved for human use, leaving the company only about half of the patent time to exclusively market a new drug. Without fair compensation from meaningful patent protection, drug research and development would slow or stop.
What are generic medications?
When the patent of a brand name medication expires, other companies may produce and sell a generic version of the drug. All generic drugs must be reviewed and approved by the FDA before they can be marketed.
FDA requirements for generic drugs:
* Generic drugs must have the same active ingredients and the same labeled strength as the brand-name product.
* Generic drugs must have the same dosage form (for example, tablets, liquids) and must be administered in the same way.
* Generic drug manufacturers must show that a generic drug is bioequivalent to the brand-name drug, which means the generic version delivers the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the brand-name drug.
* Generic drug labeling must be essentially the same as the labeling of the brand-name drug.
* Generic drug manufacturers must fully document the generic drug’s chemistry, manufacturing steps, and quality control measures.
* Firms must assure the FDA that the raw materials and finished product meet specifications of the U.S. Pharmacopoeia, the organization that sets standards for drug purity in the United States.
* Firms must show that a generic drug will remain potent and unchanged until the expiration date on the label.
* Firms must comply with federal regulations for good manufacturing practices and provide the FDA a full description of facilities they use to manufacture, process, test, package, and label the drug. The FDA inspects manufacturing facilities to ensure compliance.
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