A generic drug is a medicine formed to be the identical as a previously advertised brand-name drug in dosage form, safety, and dose, route of administration, quality, performance characteristics, and intentional use. These resemblances help to validate bioequivalence, which indicates that a generic medicine works in the similar way and delivers the same clinical advantage as its brand-name version. In other words, you can take a generic medicine as an equivalent supernumerary for its brand-name counterpart.
What are brand name drugs?
A brand-name drug product is initially discovered and developed by a pharmaceutical company. a pharma company can market and sell their product only after getting an approval from the food and drug administration (fda) by acquiescing a new drug application (nda) wherein the clinical safety and efficacy of the innovator drug under approval is present. post an fda approval, the innovator company can completely market and sell this 'brand-name' product as long as the company has patent protection. a patent permits the innovator to sell its product solely in order to recover money consumed during development and to make a revenue.
Is there any difference between working of Generic and Brand Name Medicine?
Generic medicine which is made after its brand-name drug must have the similar performance characteristics as the brand-name medicine in the body. A generic medicine is the same as a brand-name medicine in active ingredient(s) dosage, safety, effectiveness, strength, stability, and quality, along with the same usage directions. Generic medicines have the same risks and benefits as the brand-name medicines. The FDA Generic Drugs Program conducts a severe review to make sure generic medicines run into these standards and monitors drug safety after the generic medicine has been approved and brought to market. One must note that there will always be a slight and medically insignificant which evidently is bound to occur during manufacturing, for both brand-name and generic medicines. When a medicine, generic or brand-name, is produced in bulk, very small alterations in purity, size, strength, and other parameters are allowable.
Why brand medication appear differently than generic medicines?
Trademark rules in USA doesn't permit the identical external appearance of a generic and brand name drug. Generic medicines and brand-name medicines share the same active ingredient, but other features, such as colors and flavorings which do not affect the performance, safety, or effectiveness of the generic medicine can be different.
Why it is that generic medicines are cheaper than branded medicines?
Generic drugs or medicines become available only after a hard review by FDA and after a set period of time that the brand-name version has been on the market exclusively. This is because new drugs, like other new products, are typically safe by patents that forbid others from making and selling copies of the same drug. The patent defends the company's asset in the drug's development by giving the company the exclusive right to trade the drug while the patent is in effect. As it takes such a long time to bring a new drug to market, this period of uniqueness allows drug firms to recover the costs related with bringing a new drug to market. FDA also grants some periods of marketing exceptionality to brand-name drugs that can prohibit the approval of generic drugs. Once these patents and marketing exclusivities decease (or if the patents are positively challenged by the generic drug company), the generic drug can be approved. Generic drugs also tend to cost less than their brand-name equivalents since generic drug applicants do not have to reprise animal and clinical (human) studies that were obligatory of the brand-name medicines to prove safety and effectiveness. This is why the application is called an "abbreviated new drug application or ANDA". Also, there is competition between the brand-name drug and multiple generic drugs which is a major reason generic medicines cost much less. In fact, multiple generic companies are often accepted to market a single product; this creates competition in the market, naturally resulting in lesser prices.
Are generic medicines FDA approved?
Companies generally submit an abbreviated new drug application (ANDA) to market a generic drug that is the same as (or equivalent to) the brand-name version. FDA's Office of Generic Drugs evaluates the application to make sure that drug companies have demonstrated the performance characteristics of the generic medicine equivalent to that of brand-name medicine.
Is a generic version of my brand-name medicine available?
Apart from asking your local pharmacist for help, there are three ways to find out if there is a generic version of your brand-name medicine available:
Use Drugs@FDA, a catalog of FDA-approved drug products, including their drug labeling.
Search for generic equivalents by using the online version of the "Orange Book."
First, search by proprietary or "brand" name.
Second, search again by the active ingredient name.
If other manufacturers are listed above and beyond the brand-name manufacturer in result for searches by the "active ingredient," they are the generic product manufacturers.