Generic Drugs A Drug Product - 1362 Words

INTRODUCTION: A Generic drug (generics) is a drug product that is comparable to a brand/reference-listed drug product in dosage form, strength, quality and performance characteristics, and intended use. These are produced and distributed without patent protection. The Generic drug must contain the same active ingredients as the original formulation. Generic drugs are identical or within an acceptable bioequivalent range to the brand name counterpart with respect to pharmacokinetic and pharmacodynamic properties. Most of the generic products are available once the patent protections afforded to the original developer is expired, when it happens it often leads to substantially lower prices for both the original brand name product and the generic forms. Drug patents in US give twenty years of protection, but as they are applied for before clinical trials begin, the effective life of a drug patent tends to be between seven and twelve years.1 WHY GENERIC DRUGS ARE INTRODUCED The principal reason for the relatively low price of generic medicines is 1. When patents no longer protect Drugs, competition increases among producers, companies create generic drugs at less cost and are therefore able to maintain profitability at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford them. 2. Generic manufacturers don t bring about the expense of medication disclosure and rather can reverse engineer known drug compounds toShow MoreRelatedSharing For Generic Abuse Analgesic Opioid Analgesic Drug Product And Require Medicaid Services Essay914 Words   |  4 Pagessharing for generic abuse-deterrent opioid analgesic drug product and require Medicaid services or a managed care organization to be compliant with the new sections to the bill ( Kentucky.gov, 2015). Bill #HB 330(BR-990) was filed and introduced into committee on Tuesday February 2nd, 2016 and sponsored by Addia Wuchner, Joni Jenkins, Linda Belcher, Regina Bunch, Kelly Flood, Kim King, Martha Jane King, Mary Lou Marzian, Donna Mayfield, Marie Rader, Rita Smart, Diane St. Onge, Susan Westrom and JillRead MoreFactors Affecting The Generic Drug Industry998 Words   |  4 Pagesgrowth in generic drugs has slowed considerably from 42% in 2011 to 10% currently. IMS Health predicts the growth to maximize at 90% of t he prescription market (Salazar, 2015). Though there is not much room between generic drugs currently representing 83% of prescription drugs and the predicted 90% maximum, the next twelve months appear a safe investment period for the generic drug industry when considering the currently growth rate. Many factors influence success in the generic drug industry;Read MoreGeneric Medicines And Its Effect On The Human Body1007 Words   |  5 Pages The generic medicine contains the same active substance as the original pharmaceutical products. Because it works the same way in the human body, therefore, interchangeable with the original product. The generic medicines are brought to market when the originator product patent has expired. Generic medicines are increasingly being used in family doctors, specialists and hospitals, as well as effective alternatives to higher-priced innovative medicines instead. The generic medicine contains the sameRead MoreGeneric And Name Brand Drugs1126 Words   |  5 Pagescompetition between generic and name-brand drugs, these drugs show very slight differences in ability while they have a large difference in price. The FDA is in charge of overseeing the creation of these generic and name brand drugs. Too much diversity in their results is unacceptable to FDA so they keep a close watch on the makeup and effectiveness of the drugs and how they impact the human body. Along with the differences in their chemical makeups shown by the results of each drug there are the socialRead MoreHarmful Effects On The Environment And Surrounding Agricultural Lands Are The Negative Externality Effects Associated With Coal Seam Gas1691 Words   |  7 Pagesexample of a barrier entry for Monsanto in forming their market power is through government-created monopoly. As a result of the US government patenting and establishing legislation, Monsanto has the ability to †Å"license† its product and other companies are unable to produce a product identical to it unless granted to. This leads to Monsanto gaining market power, as it is the only legal entity that is able to supply these patented seeds for a period of time. 2b) Patent laws protect the rights of inventorsRead MorePatent Strategies Like Evergreening Differently Impact The Developing World1227 Words   |  5 Pagesbut unoriginal, technologies through the filing of secondary applications. This contributes to increased medical costs by keeping lower-cost generic alternatives out of the marketplace. This chapter gives an overview of the evergreening strategies that are employed by branded pharmaceutical companies as a tactic to bypass existing patent laws and limit generic competition in the marketplace. The frequency of such strategies demands strong patent interpretations that are protective of the spirit ofRead MoreManufacturing Problems And Technological Efficiency1572 Words   |  7 Pages Manufacturing Problems and Technological Efficiency Part of the challenge regarding the drug shortage is the concept of efficiency in production. Prices for generics are lower than brand name drugs and therefore profitability margins are very narrow. For this reason there is little incentive to ensure that equipment is well maintained as this adds to costs and further decreases net income to the manufacturer. Quality is not rewarded in any tangible way and offers no significant advantage, soRead MoreCompetition Within The U.s. Pharmaceutical Industry1599 Words   |  7 Pagespotential is enormous. Demand is more inelastic as prescription drugs are necessary for many individuals with illnesses such as diabetes and high blood pressure. Within the industry, there are two types of manufacturers: brand name and generic. These groups compete not only among one another, but with each other as well. Brand name pharmaceutical companies often try to, and succeed in preventing or delaying approval and circulation of generic equivalents. The most common tactic used is a reverse paymentRead MoreGeneric Drug Sector Of The Healthcare Industry1113 Words   |  5 Pages and the generic drug sector of the healthcare industry is no different. The alignment, however, is an anomaly to schools of thought that we are accustomed to. Demand for generic drugs in the United States is unquestionably high. Designed to help offer lower cost options for medications, this market provides financial relief for individuals who need medication to help with a common virus or a life-threatening illness. The disparity of medication costs can be significant for generics, with estimatesRead MorePharmaceutical Practices - Generics Essay1144 Words   |  5 PagesObstruction of Generic Pharmaceuticals in the Marketplace It has been estimated that most of the major pharmaceutical companies have engaged in some unusual practices to keep generic equivalents of their products from entering the marketplace. These measures usually have a negative effect on consumers and health care plan providers, prohibiting them from buying equally effective products at a discounted rate. The objective of the major pharmaceutical companies in attempting to prevent generics from entering