Introduction
In this text, we will try to define what generics are and how they differ from their branded prototypes. The issue will be considered on the example of such a popular drug for combating erectile dysfunction as Viagra. Viagra is a medicine based on the active substance sildenafil citrate, the main function of which is the elimination of symptoms of erectile dysfunction, not caused by problems with the level of male sex hormones. Viagra has been the most widely sold ED drug in the world from its inception to the present day.
We will provide basic information about the features of the development of Viagra and interesting facts from the history of the creation of this drug. We will also explain the mechanism of action of Viagra generics on the male body and compare it with the original drug. Making a choice in favor of one or another drug to restore potency can be difficult, so the text will provide a list of the benefits of Viagra generics, and special attention will be paid to the availability of these drugs. Lest the picture be one-sided, we will not forget to list the potential side effects and risks associated with misuse or overuse of the drug. Finally, since none of the patients who are faced with the need for erectile dysfunction therapy would like to have any legal problems, our specialists have prepared a brief overview of the legal status of Viagra generics and will provide information on the rules for buying and using Viagra generics in different countries of the world. Thus, the reader will get a basic understanding of the features of Viagra generics and will be able to make an informed choice in favor of this or another drug to normalize potency.
What is Generic Viagra?
The question of what generics are in simple terms is not too complicated. The fact is that the invention of each new drug, the process of its testing, clinical research and registration always takes a very long time. Sometimes it can take 10 years or even more from the moment a molecule of the active substance is obtained until the first package goes on sale. This is a very cost-intensive process, so original products are usually quite expensive. Often, several years after the creation of the original drug, analogues appear on the market, which are much cheaper. If they use the same active substance as in the prototype drug, then the analogues are called generics (from the Latin “generic” – similar). Thus, a eneric is a drug that basically has the same quantity and quality of the active substance as the original drug. As a rule, it is also produced in the same dosage form as its prototype, although there are changes (for example, capsules instead of tablets). In most cases, the inventor company holds the exclusive rights to manufacture and sell the drug for 20 years. After that, other pharmaceutical companies can make their own versions of this drug. Generics have the same international non-proprietary name – this is the name of the active substance.
So, for Viagra generics, like for the original drug, the international proprietary name is sildenafil citrate. However, the manufacturer has the right to change the packaging of the medicine, to give its own trade name to the medicinal product. In generics, other excipients can be used that give the drug the shape of a tablet, determine its solubility, a certain speed of onset of the effect, density, color, and so on. Also, the quality of generics can be affected by the quality of raw materials used for their production. In any pharmacological substance there is a certain proportion of impurities, and the effect of the finished drug often depends on their amount. Today, generics undergo a large number of tests and are subject to mandatory certification, which determines their generally high quality.
History and Development
The futurologists of the recent past have been diligent in predicting what other miracles the human mind will create before the end of the twentieth century. Some said that cancer would be defeated, but they were wrong. Others hoped that a universal field theory would be discovered, over which Einstein struggled for a long time and in vain – no. The third predicted the flight of man to Mars – also in vain.
And, one way or another, at the end of the century, inventors created a discovery that futurologists couldn’t even dream of. Even in the most rosy dream, such a victory of human genius over nature was never dreamed of. It was Viagra! The names of scientists who discovered the role of nitric oxide in the development and maintenance of a normal erection are now known to everyone – Robert Farchgott, Ferid Murada and Luis Ignarro.
The invention of Viagra was, apparently, the third greatest “accidental” discovery in medicine after the discovery of X-rays and Penicilinum. These discoveries were awarded the Nobel Prize. The same big award in the autumn of 1998 was given to scientists who discovered, among other things, the characteristics of the drug “Viagra”. Scientist Simon Campbell, who participated in the development of Viagra, was even awarded the title of knight of the British Empire.
The history of Viagra began in 1992 in the course of pharmacological research by Pfizer. Scientists conducted clinical trials of a new drug, sildenafil citrate, which was developed as a treatment for pulmonary arterial hypertension.
The inventors hoped that the drug would help increase blood flow to the heart muscle and lower blood pressure. Along the way, it was found that many male patients who took part in the study refuse to return sildenafil tablets, regardless of the end of testing. The reason for refusal in all such patients was the same – they all noted an improvement in the quality of erections. So, despite the least effect of the new agent on blood circulation in the myocardium, sildenafil caused a noticeable blood flow to the male genital organs.
Scientists at the pharmaceutical company Pfizer, headquartered, took this unexpected property of sildenafil with due attention and were able to recognize it as a powerful tool for combating erectile dysfunction. The new drug was named Viagra – the name was born, as it were, as a result of the merger of the words “Vigor” (power, energy, strength) and
Niagara – the most powerful waterfall in North America.
Although Pfizer’s patent for the popular erectile dysfunction drug expired in 2020, Pfizer itself began making and selling generic sildenafil back in 2017.
Function and Effectiveness
It is quite natural that the majority of men taking Viagra and its generics are interested in what is the mechanism of the effect of this drug on their sexual sphere. Generic Viagra belongs to the category of PDE-5 inhibitors. This is a group of substances that are united by the fact that they prevent the production of the PDE-5 enzyme in the male body, which is mainly present in the cavernous bodies of the penis. This is achieved through increased production of nitric oxide and the vasodilating effect of the drug. At the same time, despite the fact that sildenafil citrate is a selective inhibitor of PDE-5, to some extent it also affects other enzymes from the category of phosphodiesterases, which explains the origin of a number of side effects of this drug – for example, changes in color perception.
Since the active substance in Viagra generics is completely identical to that used in the original drug, the effectiveness of generics is no less. And, although some consumers still demonstrate a skeptical attitude towards Viagra generics, this has long been a baseless prejudice that has not died out, perhaps only because the drug is still relatively young, unlike, for example, aspirin. It also once was a branded patent medicine, and today is produced by almost all pharmaceutical companies around the world, and it never occurs to anyone to look for the “original” medicine.
Benefits of Generic Viagra
Some consumers wonder why generics are so much cheaper than original drugs. When choosing between a generic and an original when buying, many prefer a copy medicine precisely because it is significantly cheaper. There is nothing surprising, because the original Viagra costs $60 – 80 per pill. Even among US residents, few people can afford treatment with such an expensive drug, especially on a regular basis, to say nothing of those countries where the average income level of the population is lower. Meanwhile, Viagra generics can be easily bought at a price of $5-6 per tablet, and if you look for the best deals, then even for $1-3.
The low price of generics is explained by the fact that companies producing them don’t spend money on their invention, safety and efficacy testing – one of the most expensive stages of drug production. After all, the creation of a molecule of the active substance is always accompanied by unsuccessful options.
The cost of the medicine also includes excipients. In pharmacology, their purpose is to give the drug a form, to bind the main component.
The most common excipients are: magnesium stearate; corn starch; lactose monohydrate; silicon dioxide; aspartame; flavors; dyes.
If the manufacturer manages to buy raw materials cheaply, exclude or change the component without losing properties, then it will be possible to sell the medicine at a low price. The consumer has an option: buy the original Viagra or trust one of its many generic versions.
To reduce the cost of generics for the end consumer, optimizing the cost of taxes, reducing the cost of human labor is effective. Often the production of generic drugs is located in countries where the wages of workers are lower and production volumes are higher. The most striking example of such a country is India, the birthplace of the most affordable and at the same time high-quality generics of a wide variety of drugs, including Viagra.
Generics of Viagra essentially just use the finished medicinal formula of the famous original Viagra, copy it. Of course, the accuracy of copies may vary from manufacturer to manufacturer. Some companies may purify the active ingredient worse, which is why the body doesn’t perceive it very well and suffers from side effects. Others, on the contrary, even try to improve the medicine compared to the original, as a result of which it is better tolerated by the body than the original Viagra from Pfizer.
Side Effects and Risks
Viagra is one of the drugs for which the occurrence of side effects is quite frequent. Among them are headache, dizziness, redness of the skin of the face, heartburn, indigestion, blurred vision or change in color perception, nasal congestion. Depending on the individual sensitivity to the drug, these phenomena may be present to a sufficiently strong degree or absent altogether. In people with hypersensitivity to sildenafil, taking Viagra can cause nosebleeds, sleep problems, severe muscle pain in the back, tinnitus, and even loss of consciousness due to a sharp decrease in blood pressure. Moderately pronounced side effects usually subside after the first few doses of the drug.
Overdose or misuse of Viagra, especially in combination with alcohol, can lead to serious consequences for the cardiovascular system, which appear with symptoms such as chest pain, heavy breathing, arrhythmia, ringing in the ears. You should be extremely careful with the use of this medicine if you suffer from cardiovascular diseases, even compensated ones. Be sure to consult your doctor, as the consequences of improper use of Viagra may be a collapse or a heart attack (myocardial infarction). People with hereditary retinal disorders should avoid this medicine as it can damage the retina.
Legal and Regulatory Aspects
To date, everywhere in the world generics of Viagra are officially approved for sale and use of medicines, just like the original ones. Only the conditions for dispensing this medicine from pharmacies differ. So, in India, no one cares about the prescription status of this drug, it can be safely bought without a doctor’s prescription, while in Germany it is almost impossible to purchase this medicine without a prescription. If a man wants to save money or prefers Viagra generics for any other reason, no one can prevent him from purchasing generics, not the original medicine. In particular, the consumer can order generics of interest to him from abroad. Traditionally, the most stringent legislation regarding the purchase of Viagra generics, just like the original drug, is observed in the territory of the EU.
Conclusion
In conclusion, we can say that the recommendations for the use of Viagra generics are no different from those in relation to the original drug. In terms of effectiveness, generics are in no way inferior to their famous branded prototype. The current level of development of pharmacology has made it possible to provide hundreds of thousands, if not millions of men with potency problems, with an affordable medicine, and this is the merit of generic manufacturers.
References
- https://www.medicines.org.uk/emc/files/pil.1072.pdf
- https://pubmed.ncbi.nlm.nih.gov/11992853/
- [Goldstein I, Burnett AL, Rosen RC, Park PW, Stecher VJ. The Serendipitous Story of Sildenafil: An Unexpected Oral Therapy for Erectile Dysfunction. Sex Med Rev. 2019 Jan;7(1):115-128. doi: 10.1016/j.sxmr.2018.06.005. Epub 2018 Oct 6. PMID: 30301707.]
- [MacConnachie AM. Sildenafil citrate (Viagra). Intensive Crit Care Nurs. 1999 Jun;15(3):177-8. doi: 10.1016/s0964-3397(99)80050-0. PMID: 10595058.]
