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Generic drug

A generic drug (pl. generic drugs, Kurzschlu?: towards Eric) is a drug, which is produced and distributed without a label name. A generic Mu? contain the same active ingredients as the ursprungliche formulation. In most traps it is considered as bioequivalent to the Markennamegegenstucken regarding the pharmakokinetischen and pharmacodynamic characteristics. By Verlangerung therefore towards Eric accepted, in order to be identical in the dose, in the strong one, in the administrative channel, in security, in the effectiveness and in intended use. In most traps generic products are missing, until those patent protection, which are carried out to the ursprunglichen developer, ran off. If generic products become available, drove the market competition haufig essentially lower prices fur ursprungliche branded article and the generic forms. The time, which takes it a generic drug, in order to appear on the market, verandert itself. Drug patents give twenty years to protection, but they are requested, before clinical attempts begin, therefore bend the effective life of a drug patent to be between seven and zwolf years.
The principal reason fur verhaltnisma? industrial union low price of the generic medicine is, there? these companies at few expense take themselves, if they manufacture the generic drug, therefore and are able to maintain Rentabilitat with the request of the drug at lower costs consumers.

Generic manufacturers take themselves not at expense of the drug discovery and are instead of fahiger jerk engineer admitted drug means to permit to them bioequivalent versions to manufacture. Generic manufacturers also do not carry the load of the Prufung of security and the effectiveness of the drugs by clinical attempts, since these attempts were already led by the label name company. In most Landern generic manufacturers mussen only prufen, there? their preparation to the existing drug is bioequivalent, in order to win permission by the zustandige Aufsichtsbehorde. It was geschatzt, there? the average price to the MarkennameDrogenfirme of discovering and the Prufung of an individual new drug $800 million as being as many can. [1]

Generic Drogenfirme konnen the use of the preceding marketing Bemuhungen of the label name drug company, einschlie? lich the announcing means, which representations also receive by Drogereprasentanten and the distribution of the free samples. Many of the drugs, which are eingefuhrt by generic manufacturers, are already on the market fur a decade or admit more far away been, and konnen to the patients and to the servicers already its (although haufig under their geeinbrannten name).

Before the purge of a drug patent, genius? t a label name company one period · of Marktexklusivitat” or of monopoly, in which the company is, the price of the drug on the level to adjust, which maximizes Rentabilitat. This price ubersteigt haufig gro? production costs of the drug, which can the drug company ermoglichen to form an important profit on their investment in the research and in the development. The advantage of the generic drugs to the consumers comes into the introduction of the competition, which prevents each individual company at prescribing the entire market price of the drug. With repeated enterprises the profiting maximizing price reflects generally the away-protecting costs of producing the drug, which is normally many lower than the Monopolpreis.

Patenterteilungen

When can a generic drug be produced?

If a pharmaceutical markets company first a drug, she normally is under a patent, which only company permits the pharmaceutical, which developed the drug, in order to sell her. Generic drugs konnen fur drugs permit-prove to be produced, where: runs off, 2) the D has 1) the D patent generically company bestatigen D mark company Patent its either unzulassig, in complainable or not its will not hurt, for 3) fur drug what have never holds patent, or 4) in country where a patent is/are not not into force. The purge of a patent removes the monopoly, that of the patentee on drug sales for approving. Patent lifetime differs from country to country, and gewohnlich there is no way to renew a patent after it run off. A new version of the drug with important and run towards one at the means could be patented, but this requires new clinical attempts and does not prevent not the generic versions of the ursprunglichen drug.

This permits to the company to bring in the costs of the Entwickelns that again certain drug. After the patent on a drug run off, each pharmaceutical company can this drug manufacture and sell. Since the drug was approved already gepruft and, are the costs of the drug simply manufacture a break of the cost price of the Prufung and the Entwickelns certain drug.

Difficult patents

MarkennameDrogenfirme used a number of strategies, around the period of Marktexklusivitat on their drugs too verlangern and generic competition to prevent. This can include konkurrenzfahigen law case also, around patent protection on its medicine, a Proze? to conserve or too verlangern, which refers from the critics, as · evergreening.” Patents become gewohnlich on pharmakologischen means of the novel quite fruh in drug development the Proze? given change, to which time begin · the master clock” to tick to the purge to patent. Spater in the Proze? , Drogenfirme new patents on the production of of the specific konnen forms of these means, as individual Enantiomere of the drugs looks for, which exist rechtshandigen” forms in · linkshandigen” and · konnen, [2], different unaktivierte components in a drug salt, [3] or a specific hydrate form of the drug salt. [4] If they are granted, these patents set · the master clock” to patent purge zuruck. This kind of patents can be aimed fur cancellation by generic drug manufacturers more spater. [5] [6] [7]

Generic Drogeexklusivitat

USnahrungsmittel and the drug line offers 180 Tagesexklusivitatperiode to generic drug manufacturers in the specific traps. Protecting generic manufacturers of these konnen the period (or sometimes some) the generic version of a drug only produce. This Exklusivitatperiode is used only if a generic manufacturer argues, there? a patent is unzulassig or in the generic production of a drug is not hurt, and the period serves commitment as a reward fur the generic manufacturer, that is ready, with court to risk and the costs of the patent court right controversy. There is haufig intention around these 180 Tagesexklusivitatperioden, because a generic producer protecting this period do not produce the drug mu? and a request first to place knows, in order to prevent other generic producers from selling the drug.

Gro? e pharmaceutical companies spend haufig thousands dollar, which schutzen their patents before generic competition. Apart from law case companies use other methods such as new formulation or an approving of a subsidiary (or another company) towards Eric under the original patent to sell. Gene Eric sold under license of the patentee admits as authorized of towards Eric; they do not become up to the 180 Tagesexklusivitatperiode beeinflu? t, protecting them with the ursprungliche application of drugs of the patentee fall.

A main example of, how this works, is simvastatin (Zocor), a populare drug, those by US gegrundetes pharmaceutical Merck and Co. and manufactured is lost, its US patent protection is manufactured on 23 June 2006. Ranbaxy laboratory (at that magnesium 80 strong ones) India gegrundete and Israel gegrundete Teva pharmaceutical industries (at all further strong ones) received 180 Tagesexklusivitatperioden fur simvastatin; because of the Popularitat Zocors, began both companies marketing their products, immediately after the patent ran off. However Dr. Reddys Laboratories markets also an authorized generic version of simvastatin under license of the manufacturer, of Merck and from CO. Zocors; some packages of Dr. Reddys simvastatin even show Merck as the do-material manufacturer and have trade marks of Merck on the lower surface.