generic drug


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generic drug,

a drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name. The name of the active ingredient is established by a government or international body, and is typically the U.S. Adopted Name, British Approved Name, or International Nonproprietary Name. Generic drugs must contain the same active ingredients that their brand name counterparts do and are tested to assure that they are therapeutically equivalent, but they may contain different inactive ingredients from those found in the brand name medications.

There are generic versions of both over-the-counter and prescription medications, but not all drugs have generic equivalents. Generic drugs can only be produced when a patent on a brand name drug expires or when a patent has never existed. They are generally cheaper than the equivalent brand name drug because of much lower marketing and development costs. Because a generic competitor can hurt a brand name manufacturer's profits, drug companies have used legal action and regulatory delays to slow the introduction of generics, or have paid generic manufacturers to postpone the production and marketing of generics. The Medicare overhaul legislation passed in 2003 contained sections designed to speed the introduction of generic drugs by making it easier to challenge weak or invalid drug patents. Production of generic drugs (and increasingly, drug generally) in foreign countries, however, has been hard for the Food and Drug Administration inspect and certify.

References in periodicals archive ?
(77) Generic drug manufacturers would be unilaterally responsible for updating their drugs' warning labels, so the protection granted to generic manufacturers in PLIVA would no longer apply if the proposal is accepted.
TechNavio's report, the Generic Drugs market in Japan 2015-2019, has been prepared based on an in-depth market analysis with inputs from industry experts.
The Court began its analysis by emphasizing the duty arising under both Minnesota and Louisiana law, which "require a drug manufacturer that is or should be aware of its product's danger to label that product in a way that renders it reasonably safe." (45) The Court then contrasted this duty with federal law and regulations imposed upon generic drug manufacturers, which is "far more complex." (46)
Here, pharmacies can work together with insurers to manage care for patients who have to change to a generic drug for financial reasons, or even from one generic to another.
Generic drug company executives "sowed the seeds" for the price run-ups at trade shows, conferences, industry dinners, girls nights out or any other event in which interaction was possible, the multi-state lawsuit claims.
1, 2017, would prohibit a significant price increase of an essential off-patent or generic drug and give the Maryland attorney general the power to order the manufacturer to explain the reasons behind a significant price boost as well as request a court order restraining or enjoining a violation.
The Food and Drug Administration Generic Drugs Program conducts a rigorous review to make certain generic medicines meet these standards, in addition to conducting 3,500 inspections of manufacturing plants a year and monitoring drug safety after the generic medicine has been approved and brought to market.
In India, generic substitution is legally not allowed, so patients' awareness about generics is limited and patients do not want to change from prescribed innovator to generic drug. In this study, maximum participants gave the opinion that legally patients should be given freedom to choose generic or innovator drugs.
"We believe that Project Rx may drive other nonprofit and for-profit manufacturers to enter generic-drug markets, compete among themselves, and collectively improve market efficiency and broaden access to generic drugs," the authors write.
on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
Still, this single dramatic increase shed light on the once obscure arena of older generic drugs that continue to be in short supply and whose (https://www.theatlantic.com/health/archive/2015/09/daraprim-turing-pharmaceuticals-martin-shkreli/406546/) prices occasionally skyrocket.
generic drug industry is composed of numerous relatively small firms with small product portfolios.
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