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In most cases, generic products become available after the patent protections afforded to the drug's original developer expire. Once generic drugs enter the market, competition often leads to substantially lower prices for both the original brand-name product and its generic equivalents. In most countries, patents give 20 years of protection.
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs.In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. [1]
An International Nonproprietary Name (INN) is an official generic and nonproprietary name given to a pharmaceutical substance or an active ingredient, [1] encompassing compounds, peptides and low-molecular-weight proteins (e.g., insulin, hormones, cytokines), as well as complex biological products, such as those used for gene therapy. [2]
Generic term, a common name used for a range or class of similar things not protected by trademark; Generic trademark, a brand name that has become the generic name for a product or service; Generic name (pharmaceuticals), a nonproprietary name used as an identifier for pharmaceuticals. Naming systems include: International Nonproprietary Name ...
USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
For example, under a 3-tier formulary, the first tier typically includes generic drugs with the lowest cost sharing (e.g., 10% coinsurance), the second includes preferred brand-name drugs with higher cost sharing (e.g., 25%), and the third includes non-preferred brand-name drugs with the highest cost-sharing (e.g., 40%). [7]
A British Approved Name (BAN) is the official, non-proprietary, or generic name given to a pharmaceutical substance, as defined in the British Pharmacopoeia (BP). [1] The BAN is also the official name used in some countries around the world, because starting in 1953, proposed new names were evaluated by a panel of experts from WHO in conjunction with the BP commission to ensure naming ...
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an ...