In the Russian Federation, the period of validity of a patent for an invention related to a medicinal product, the use of which requires obtaining a permit in accordance with the procedure established by law, is extended by the federal executive body for intellectual property at the request of the patent holder for a period calculated from the date of amoxil an application for an invention until the date of receipt of the first such authorization to use, minus five years. In this case, the period for which the patent for an invention is extended may not exceed five years.

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After the expiration of amoxicillin, other manufacturers can reproduce and release on the market a similar drug (the so-called generic), if the bioequivalence of the reproduced and amoxicillin original drugs is proved.


At the same time, the technology for the production of a generic can be any, but not covered by the patent protection existing in the country.

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Of course, the generic manufacturer cannot use the brand name for this drug, but only the International Non-Patent Name (INN), or any new patented by him (synonym). Despite the new name, in terms of their medicinal effect, the drugs can be similar or very close.

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But amoxil is different, a different degree of purification is possible.

 There are other factors as well.

For example, it is known that for a long time different companies could not achieve the same effectiveness of acetylsalicylic acid (for generics) as Bayer AG, the manufacturer of the original aspirin drug. It turned out that the matter is not only in the purity of raw materials, but also in a special method of crystallization, which results in special, smaller crystals of acetylsalicylic acid. There can be many such nuances. The opposite result is also possible, when the generic is more successful than the original medicine.

Large pharmaceutical companies have a policy of aggressive advertising of their products. It is believed that 85% of widely advertised new medicines have serious problems: they do not undergo clinical trials, have the wrong dosage, they have no evidence of clinical efficacy and data on side effects.
Companies are investing in persuading doctors to prescribe their new drugs to patients (and this is where misinformation is possible), as well as to convince consumers of the effectiveness and low potential harm of products. At the same time, they often provide licensing authorities with incomplete, only partially compliant clinical trial results.
The pharmaceutical business is ranked third in terms of profitability after the arms and drug trade. This attracts unscrupulous entrepreneurs to him. In Russia, until 1991, the problem of drug falsification was practically absent.
After the collapse of the USSR, caused by this decreaseproduction of own drugs and a sharp increase in imports, the problem has become urgent. About a tenth of all drugs sold on the world market are counterfeit or counterfeit.
The first official amoxil of detecting counterfeit drugs in Russia was registered. 2004 Introduction of the concept of “counterfeit drugs” into Russian legislation [?] A distinction should be made between drug falsification and counterfeit drugs. This is especially important in view of the total legal and pharmaceutical illiteracy, when all medicines produced with any violations are called “falsified”.

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