Generic medications classification around the globe: PDE-5 drugs
In the pharmaceutical market there are three main types of medications. Firstly, the original drug, the chemical formula of the active substance of which is approved and patented. The patent extends to a certain territory (country) and is limited to a certain time period. The original preparation is the first drug in its class. A decent example in ED lineup is drug Viagra (sildenafil citrate) by Brand Company, the preparation that became the founder of the class of inhibitors of phosphodiesterase type 5 (PDE-5).
Secondly, come the me-too products: they also have an original patented molecule, although it may be close to the structure of the molecule of drugs-ancestor class. These drugs are sometimes superior to the ‘first in the class’ meds in efficiency or safety, and sometimes the differences are quite conventional with the grain of marketing. Getting back to the class of PDE-5 inhibitors this type of drug is assigned to Levitra and Cialis.
The third type of drugs includes generic meds, the ‘copies’ of the original, or me-too products entering the market on the expiry of their patents. Continuing the analysis of the group of phosphodiesterase type 5 inhibitors, the fact should be underlined that generic drugs have stepped into the market aggressively in 2012, when Viagra patent has gone. Thus, the largest generic manufacturers, Indian Corporation was granted a tentative FDA approval (Food and Drug Administration, Office of the Food and Drug Administration) for the production of generic Viagra(click here to read generic viagra review by canadian pharmacy) 5 years before an anticipated date in April 2007. The copies of original drugs appear on the market under their own brand names or generic brands.
For products of manufactured in Brazil or Eastern Europe from a practical point of view, the above-described classification has a limited use due to national peculiarities of pharmaceutical markets. On the one hand, the problem of protection of intellectual property rights was seriously faced by market participants only. Thus, the question of allocating drugs, formula development and implementation in certain regions (China and post-USSR), the type of original remained open, since patenting was not that developed. Also on the pharmaceutical market of China and Southern Asia countries a significant share of drugs based on medicinal plants (as well as preparations of animal origin) is largely used. The assignment of this group of products to a particular type is difficult due to a lack of the possibility of obtaining a patent for such drugs.
In some regions first in class drugs, as well as drugs with signs of originality or me too drugs are attributed to the original drugs group; while generic copies of these medications are classified as generics drugs (in developing regions, some classes of drugs are represented only by generic companies as originators for one reason or another have withdrawn their products in the area); other drugs that have been mentioned above, are included in the group of traditional drugs.
Against the backdrop of a small proportion of generics in terms of money and in the packaging segment share of ‘traditional’ products is significant in Eastern Europe: last half accumulates more money in the market and about 80% in the packages. In the Romania, Bulgaria and Turkey the sales of original and generic drugs are relatively close to each other, whereas in Russia the original drugs are sold 2 times more frequently than generic drugs.
In the hospital sector of pharma markets of Russia and Kazakhstan in comparison with retail recorded a higher proportion of generics. In the United States the share of these products in the total volume of retail sales and hospital purchases is close (the country consumes around 47% of generic preparations in general proportion). The analysis of the share distribution of various kinds of drugs in various channels revealed that the maximum share of generics in the segment of the preferential provision in the United Kingdom has reached 28%.
The average cost of the package generics drug sold in pharmacies (retail prices), corresponds to the same figure for the hospital sector (wholesale prices) in all Western European countries. Compared with Russia, the latest has a more expensive price structure.
The lobbying and advantages
Politicians usually support generic companies. Particular activity start is typically made before the next elections or other periods when they need political support from the people. Thus, e.g. George W. Bush has sent a welcoming letter to the next congress of Generic Pharmaceutical Association of the United States, which was held on January 29, 2003 that radiated the overwhelming support of ‘the ongoing work to ensure access to quality medicines’. He also wrote in his letter ‘by keeping billions of dollars to consumers, generic drugs play a critical role in helping Americans to access essential medicines and medical advances in order to live better and longer’.
The competitiveness of generics
Of course, the main advantage of generics is their affordability. Thus, for example, the costly lineup of erectile dysfunction preparations starting from $15-20 per pill, can be choose at such drugstore as Canadian Pharmacy service canadianhealthcaremalll.com without any risks of a loss in quality. The very first copy of the original drug entering the market, implies heavy discounts on the price of the original brand, as well as the emergence of new players in the market which means the price range falls further. Numerous studies conducted in different markets are shows that during the first year of generics emergence eroded to 60% of the original. And after one year it drops to 30-35%.
Such a significant gap in the low level of the original product can be easily explained: the first reason is the cost-effective processes and business model of companies that create copies. Copier firm even in the most difficult in terms of regulatory requirements in the US market have to spend more than a few million dollars to prepare an application for registration of the drug. It does not go to any comparison with the cost of innovation companies.
And, secondly, the manufacturers of generic drugs have virtually no commercial risks, because embedded in the already formed segment they do not spend any significant funds for the formation of opinion about the medicine. And, of course, the main attraction of its objects are best selling drugs with well-developed sales and a positive image. The orphan preparations do not interest such companies, and the basis of the development strategy of these companies is to bet on the development of sales and drugs used for the treatment of rare diseases do not meet this criterion.
Due to a significantly lower price of generic drugs the introduction of a medication in the market in the first year may result into an average of 55-65% capturing of sales. By the end of the second year, this percentage increases to 70-80%. Sometimes the erosion reaches the market with even more impressive tendencies. In September 2001, company manufactured of Cialis has lost its patent rights for Prozac, and within 1 month from the beginning of the market introduction of generic copies the company has lost over 80% of sales.
By Canadian Online Pharmacy Team: http://www.canadianhealthcaremalll.com