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| Brand-Name and Generic Drugs |
| What are Generic Drugs Generic drugs are considered identical, or bioequivalent to the brand-name originals. They contain the same active substances and have the same quality, efficacy and safety. Generics may contain different inactive ingredients that do not have therapeutic effect. |
| Brand Drugs and Generic Equivalents. Patent Protection The brand name is the name under which a new innovator medication is developed and marketed. When a pharmaceutical company develops a new medication, they obtain patent for it. Brands are usually given patent protection for about 20 years. When the patent of a brand-name drug expires, other companies can introduce its generic version. Efficacy and Safety Generics are as safe as effective as the brand-name drugs. They show exactly the same pharmacological and clinical effects, and have the same risks and benefits as the brand-name products. Bioequivalence studies The generic products must be bioequivalent to the originator medication. As generic drugs contain the same active substance, there is no necessity to repeat the pharmacological and clinical tests made with the original. Instead, they are replaced by bioequivalence studies. Both drugs are considered bioequivalent when they show same rate and extent of absorption in the human organism. Quality Both brands and generics are of the same quality, as their facilities have to meet the same strict productions standards of Good Manufacturing Practice (GMP). Price Generic drugs are considerably less expensive than the brand-name products, as the generic manufacturers do not have the costs necessary for development of an original product. The price of the generics is 30%-80% lower than the price of the equivalent brands. Benefits for the Society Generic drugs provide a major benefit to the society. The healthcare systems save much money by the use of cost-effective generics. About 50% of all prescriptions in the United States, and more than 40% of all prescriptions in Canada are filled with generic medications . Facts on Generic Drugs Brand-Name Products and Generic Equivalents Of the 11,167 FDA-approved drugs listed in the FDA's Orange Book, 8,400 have generic equivalents. Generic Drugs Sales The global sales of generics will increase from $29 billion in 2003 to $49 billion in 2007 (IMS Health). The sales of generic drugs are expected to increase by 14% per year. Generic Drugs Price In 2004, the average price of a brand-name drug was $96.01, whereas the average price of a generic medication was $28.74 (data from the National Association of Chain Drug Stores). Generic drugs account for 51% of all prescriptions dispensed in the U.S. Generic Drugs Savings FDA-approved generics provide the same health benefits as brands, but cost on average 70% less. These medications save consumers approximately 10 billion each year at retail pharmacies. Consumer Attitudes In a survey performed by ChangeWave Research in 2002, 59% of the consumers said they ask their doctor if a generic pharmaceutical is available for their treatment. More Information on Top Generic Drugs Buy Generic Drugs from Trusted Pharmacies Glossary of Terms Brand Name (Trade name) The brand name is patented by the originator pharmaceutical company, which has developed the medication. The trade name indicates that the drug is an exclusive property of the company that has invented the medication. Drug Defined by FDA and US law as any substance intended for use in the diagnosis, cure, relief, treatment or prevention of diseases. Drug Safety All drugs have side effects. A drug is considered more safe when the benefits of its use strongly overweight the risks. Generic alternatives have same risk-benefit profile as the the brand-name drugs. Drug Recall The FDA is responsible for ensuring the safety of the drugs. A recall is an action taken to remove a product from the market. Recalls are conducted by request from FDA or by an initiative of the producer. FDA (Food and Drug Administration) The agency in the US responsible for marketing approval and control of the medicinal products. The FDA is responsible for ensuring the safety and efficacy of the medical products, including the prescription and over-the-counter drugs. Generic Drugs (Generics) Generics are considered identical, or bioequivalent to the brand-name drugs. They contain the same active substance included in the same pharmaceutical form as the original product and have the same quality, efficacy and safety. They are marketed after patent expiry of the brand-name original. Generic Name (INN, International Non-proprietary Name) This is the scientific name used to identify a specific molecule. Generic drugs are generally known by their INN rather than under a trade mark name. Generic Prescription Drugs Generic medications, dispensed with prescription. Good Manufacturing Practice (GMP) Good Manufacturing Practice ensures that pharmaceutical products are manufactured after specific standards of quality. Marketing Authorisation (Marketing Approval) The drugs are evaluated by the authorities and approved before they may be marketed. A licence is issued by the agency for approval of the product for the market. The agency in the US responsible for marketing approval of new products is FDA. Nonprescription Drugs Over-the-counter medicinal products (OTC); Medicinal products, dispensed without prescription. Patent Protection New pharmaceuticals are developed under patent protection. The patent protects the company investments and prohibits other companies from making, using or selling the drug. Brand-name drugs are usually given patent protection for more than 20 years. |
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