What's the difference between generic medication and name brand?
293885#19
Before a company can market a generic drug, it needs to file an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration, seeking to demonstrate therapeutic equivalence to a previously approved "reference-listed drug" and proving that it can manufacture the drug safely and consistently. For an ANDA to be approved, the FDA requires the bioequivalence of a generic drug to be between 80% and 125% of the innovator product. (This range is part of a statistical calculation, and does not mean that generic drugs are allowed to differ from their brand-name counterparts by up to 25 percent.) The FDA evaluated 2,070 studies conducted between 1996 and 2007 that compared the absorption of brand-name and generic drugs into a person's body. The average difference in absorption between the generic and the brand-name drug was 3.5 percent, comparable to the difference between two batches of a brand-name drug. Non-innovator versions of biologic drugs, or biosimilars, require clinical trials for immunogenicity in addition to tests establishing bioequivalency. These products cannot be entirely identical because of batch-to-batch variability and their biological nature, and they are subject to extra rules.
Generic drug
611768#1
Having unambiguous standard names for each drug (standardization of drug nomenclature) is important because a drug may be sold by many different brand names, or a branded medication may contain more than one drug. For example, the branded medications Celexa, Celapram and Citrol all contain the same active ingredient: citalopram; and the branded preparation Lemsip contains two active ingredients: paracetamol and phenylephrine.
International nonproprietary name
421981#14
Many markets for commonly used goods feature products which are perfectly substitutable yet are differently branded and marketed, a condition referred to as monopolistic competition. A good example may be the comparison between store brand and name brand versions of medications - the products may be "identical" but the packaging is differentiated by the vendors. Since the goods are essentially alike, the only genuine difference between them is the price - their vendors rely primarily on price and branding to effect sales. In those sectors consumer choice is usually driven by discriminate according to "lowest price", with higher-priced variants relying on a sense of exclusivity created by slicker branding to maintain competitiveness.Perfect substitutability is significant in the era of deregulation, since there are usually several competing providers in a field (e.g. electricity suppliers) each retailing exactly the same product. The result is often aggressive price competition between the retailers.
Substitute good
772990#12
In an effort to limit the cost of PBS, the Australian Government introduced Brand Premiums on medications where cheaper generic brands were available. The Brand Premium is usually the price difference between the innovator brand and the generic brand. The patient pays the Brand Premium in addition to the normal patient contribution if they decline to purchase the generic brand. The Brand Premium paid does not count toward either safety net threshold and must still be paid even after the threshold is reached.
Pharmaceutical Benefits Scheme
350292#42
A generic drug is a chemically equivalent, cheaper version of a brand-name drug. A generic drug form is required to have the same dose, strength and active ingredient(s) as the brand name drug; thus, they carry the same risks and benefits. To ensure compliance, the FDA Generic Drugs Program conducts stringent reviews (3,500 inspections of manufacturing plants per year). Although generic drugs sound like a great money-saver, generic medicines can only be sold after the patents of the brand name versions end. Because of this mandatory period of exclusivity for many brand-name drugs (a period in which generic medicines cannot be sold), delay of generic drugs reaching the market is expected. The high cost of upfront research that the brand-name products have to go through to ensure safety and efficacy largely account for the high discrepancy in pricing between the two groups.
Prescription drug prices in the United States
293885#17
Bioequivalence does not mean generic drugs must be exactly the same as the brand-name product ("pharmaceutical equivalent"). Chemical differences may exist; a different salt or ester may be used, for instance. Different inactive ingredients means that the generic may look different to the originator brand. However, the therapeutic effect of the drug must be the same ("pharmaceutical alternative"). Most small molecule drugs are accepted as bioequivalent if their pharmacokinetic parameters of area under the curve (AUC) and maximum concentration (C) are within a 90% confidence interval of 80–125%; most approved generics are well within this limit. For more complex products—such as inhalers, patch delivery systems, liposomal preparations, or biosimilar drugs—demonstrating pharmacodynamic or clinical equivalence is more challenging.
Generic drug
3260631#1
A rational drug policy is one based on drug use in which patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community. Pharmaceutical companies make considerable money by selling drugs under their trade names, promoting the branded drugs as against those named generically. Doctors often prescribe branded drugs which are more expensive than generic drugs which have the same efficacy.
Essential medicines policies
293885#26
Some generic drugs are viewed with suspicion by doctors. For example, warfarin (Coumadin) has a narrow therapeutic window and requires frequent blood tests to make sure patients do not have a subtherapeutic or a toxic level. A study performed in Ontario showed that replacing Coumadin with generic warfarin was safe, but many physicians are not comfortable with their patients taking branded generic equivalents. In some countries (for example, Australia) where a drug is prescribed under more than one brand name, doctors may choose not to allow pharmacists to substitute a brand different from the one prescribed unless the consumer requests it.
Generic drug
350292#39
Prices vary from one pharmacy to another as listed prices determine what the insurance companies will have to pay for the drug. Therefore, patients are rarely expected to pay the high prices listed for each prescription. According to the 2017 consumer reports, it is important to compare prices of various retail pharmacies to get the best deal. Other tips include seeking 90-day prescription when possible, asking for the lowest price when deciding to pay for a medication, asking for generics (refer to "Generics versus Brand-name Products" for more details regarding generic drugs vs. brand-name drugs), comparing insurance plans and talking to your doctor about costs in order to find cheaper alternative(s).
Prescription drug prices in the United States
1330266#11
A generic brand skin care product may have a consumer unsure about its ‘health and safety’ quotient. This implies that there are certain product categories more aligned to generic brands. Examples include over-the-counter medications, cereal and gasoline among others.
Generic brand