Sildenafil Vs Viagra – What Is The Difference?

The short answer is absolutely nothing.

To explain this properly we’ll look at the long answer.

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The History of Viagra

pfizerGoing back to the very start of the drug development process, one drug company will spend anywhere up to £1.2 billion and take up to 12 years to develop one new drug that reaches the market. This money is used in the discovery or design of the drug and clinical trials to prove it has the effect it is supposed to; it is safe to use; and what side effects might occur in using it. In the case of Viagra, it was developed by Pfizer and marketed from 1998. The name Viagra is the brand name, decided upon by Pfizer, while the scientific name of the drug, known as the generic name is sildenafil, this is decided upon by an expert committee.1 A new drug needs authorisation from a drug licencing authority to confirm its effectiveness, quality and safety before it can be used in the public and this is gained in America from the Food and Drug Administration (FDA) and in the UK by the Medicines and Healthcare products Regulatory Authority (MHRA). When the drug is first developed, the company that has developed it receives a patent for the drug that lasts for a set time, for example, 20 years.2 This gives them exclusive rights to the drug and means no one else can manufacture and sell that drug for 20 years; until the patent is up.

What Happens When Medication Comes Off Patent?

Once these 20 years are up, it’s anyone’s game and this is when the competition starts. Drug companies known as generic manufacturers can now apply to make and sell the same drug, under what is known as the generic name, in this case, sildenafil. This manufacturer is not required to carry out the costly animal and human trials and clinical research that the first company was required to, as it is now known that the drug does work and viagra is safe. However, the company must still meet certain standards for the drug to be approved. The generic form of the medication must contain the same active ingredient at the same strength as the branded drug; be in an identical dosage form e.g. tablet or capsule and must be taken in the same way; must be for the same indication; meet the appropriate standards for batch identity, quality, purity and strength; and be manufactured under the strict standards of good manufacturing practice required for the branded drug. The most important factor is that the generic drug is bioequivalent to the brand. This means that the tablets will contain the same amount of active drug substance and when taken; the same amount will be absorbed into the body; act in the same way; and will produce identical effects to the branded drug; and obviously, be used to treat Erectile Dysfunction

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As these generics manufacturers are not making the new drug from scratch, and are essentially copying the formula from another approved drug, they do not have to spend the huge amount of money on development and clinical trials. This allows this drug to be sold at a much lower price, and so is much more cost effective for health care providers and patients.

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As many different generics companies can manufacture the same drug once the patent is expired, this allows competition between them and can drive prices down even further. The cheaper drug does not mean lower quality; it is simply because the companies did not have to foot the bill on development, testing, marketing and promotion of the drug. By the time their generic comes to market, the healthcare industry is aware of the drug and knows what it does, how effective it is and what side effects it can cause. This means a very reduced spend on advertising of the drug.Viagra 50mg

Conclusion

So in conclusion, Pfizer developed the branded product Viagra, containing the drug sildenafil. After the patent expired in 2013, generics companies such as Teva were able to begin manufacturing the sildenafil tablets, which have to be proven to work in the same way and have the same effect as Viagra and are manufactured to the same quality standards as all other drugs. There is no difference in the effect of the two products. Since Pfizer did all the work in the research, clinical trialling and marketing of Viagra, generics companies did not have to spend the millions of pounds required to do this. Therefore the price of sildenafil is much less than that of Viagra, and it is, therefore, the more cost-effective option.

 

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References

1 NHS Choices http://www.nhs.uk/Conditions/Medicinesinfo/Pages/Brandnamesandgenerics.aspx Accessed 01.11.14

2 FDA http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm Accessed 01.11.14

3 Franl, R., 2007. The Ongoing Regulation of Generic Drugs. N Engl J Med 357. http://www.nejm.org/doi/full/10.1056/nejmp078193 Accessed 01.11.14

 

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