If you’re considering ED treatment, chances are you’ve come across two medication names: sildenafil and Viagra. Sildenafil is the name of the active ingredient in Viagra, a branded, FDA-approved version of this popular ED medication. Sildenafil is also referred to as “generic Viagra” when referring to other forms of sildenafil available on the market that aren’t branded.
Are sildenafil and Viagra the same thing? Yes, if we’re talking about mechanism of action (i.e., how they treat ED). However, there are some differences between generic and branded medications that are important to be aware of, including cost, available dosages, and regulatory approval status.
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How they work
Sildenafil (sildenafil citrate) is the active ingredient in Viagra. It’s a drug that belongs to a family of medications called PDE5 inhibitors. These drugs help treat ED by causing the relaxation of smooth muscle that lines the inside of blood vessels, allowing for increased blood flow to parts the body such as the penis. It’s a common misconception that ED medications like sildenafil cause spontaneous erections—the drug only works if you’re sexually stimulated.
History and FDA approval
Viagra is a brand name owned by the pharmaceutical company Pfizer. When drugs like Viagra are first developed and approved for sale (1998), they’re initially under patent which helps ensure that the company retains control over their intellectual property. While a drug is under patent, no other potential “competitors” can develop, manufacture or market the same active ingredient. For example, with Viagra (the branded form) under patent, no company would be able to develop, manufacture or market any form of sildenafil (the generic form).
When patents expire (which was the case in 2012 for Viagra), other companies or brands can begin manufacturing and marketing their own versions of a drug, referred to as generic medications. These generic medications cannot use the Viagra name or branding, but contain the same active ingredient, the chemical compound sildenafil.
Generic vs branded drug approval: in a nutshell
Generic versions of medications that are marketed in North America must apply for and receive FDA (in the USA, or Health Canada in Canada) approval. Going through the process of approval helps ensure that these generic medications are held to a high standard for safety, efficacy, and quality. The process through which generic medications receive FDA approval is different to the approval process for a novel drug when it is approved for the first time.
Although generic medications contain the same active ingredient, companies and manufacturers still need to prove that their generic medication is essentially equivalent to the branded in how it is absorbed, metabolized, and eliminated from the body and that the generic version can be produced at a high quality.
FDA approval for new drugs can take 10 or more years while approval for generics occurs much more quickly because they don’t require the lengthy clinical studies a new branded drug is required to do for approval.
Effectiveness and safety of sildenafil vs Viagra
A big question that many patients wonder about is whether generic sildenafil vs Viagra are equally effective. If the active ingredient in a generic medication is the same as the branded version and is present in the same quantity in the generic formulation, then yes, the medications being compared are expected to offer the same benefits. When it comes to which of sildenafil vs Viagra and the most effective treatment for ED, the answer is that most physicians believe that they can be used interchangeably to help manage this condition.
In fact, clinical trials involving sildenafil, and particularly studies that take place in regions outside of North America, use other branded versions of sildenafil. The efficacy and safety findings from these studies are no less legitimate. In Mexico for example, sildenafil is sold under the brand names Figral and Mazzogran. The names are different, but fundamentally, they are still forms of sildenafil that are being prescribed by doctors to treat ED.
Okay. So, we’ve established that branded and generic Viagra do the same thing, but are there any safety concerns patients should be aware of? The safety profiles for generic and branded medications are expected to be the same for the reasons outlined above which explains why branded and generic versions of the medications are essentially interchangeable. Additionally, generic medications manufactured in the US and Canada are produced following strict regulations for quality outlined by the FDA and Health Canada.
Speaking more generally, in some cases, the manufacturing of generic medications takes place in countries outside of North America. The FDA does not audit every single manufacturer and there have been rare reports of drug contamination in medications that are exported for sale in North America. It’s important to note that although these cases exist, they are relatively uncommon, and the risk posed by potential contaminants has historically been low (Hussar, 2020). Male ED drugs as a category of treatments, has been subject to tampering and contamination. These are usually associated with drugs that are being sold illicitly, either through unverified online pharmacies or even gas stations. You can protect yourself by making sure that you’re consulting with a licensed healthcare provider for your ED prescription and getting this filled at a licensed pharmacy.
Pricing comparison
The sildenafil vs Viagra price difference can be significant. It’s estimated that up to 90% of prescriptions filled in the US are for generic medications and the reasons for this are generally good—generic medications increase access to potentially life-saving medications by lowering costs significantly.
The cost of sildenafil will vary based on the region it's being sold in and the cost determined by the company that manufactures or supplies it. According to pharmacychecker.com, which aggregates different prices for drugs based on pharmacy information across the US and internationally, at the time of writing, a 100 mg dose of oral sildenafil could cost as little as $0.88 per tablet. Branded Viagra by comparison costs $90 on average per pill. What’s responsible for this dramatic difference in cost? Branded Viagra takes into consideration additional research and development costs. As long as you’re getting your sildenafil from a legitimate source, your sildenafil generic medication should deliver all the same benefits (and carry similar risks) as branded Viagra.
Dosage options for sildenafil vs Viagra
The dosage options for sildenafil are the same as Viagra. This PDE5i is available in 25, 50, and 100 mg tablets or pills and in some countries as oro-dispersable films (or ODFs). The starting dose for sildenafil and Viagra is 50 mg, but this may be different depending on your individual needs and medical history. Your doctor will work with you to determine your optimal dosage.
There are a few general pointers to keep in mind: regardless of whether you’ve been prescribed branded or generic Viagra, it’s recommended that you take your medication at least 30-60 minutes before sexual activity. It’s not essential to do so on an empty stomach, but you may want to avoid taking your medication after a high fat meal. Keep an eye on your alcohol intake, too— drinking too much can interfere with the efficacy of your ED treatment. You can read more about the relationship between alcohol and ED by visiting our article.
When to talk to a doctor
So those are the differences between sildenafil and Viagra. The big picture is that they’re essentially the same drug with the biggest difference being cost savings for the generic version. When consulting with your doctor, assuming both options are available to you, you can specify whether you’d prefer the branded or generic version. Your doctor can make a note of this for your pharmacist. Additionally, your doctor will also consider your medical history and needs to determine which dosage you should take.
With any medication, it’s essential to maintain open and regular communication with your doctor about how your treatment is going and especially if you have any concerns about potential side effects. While sildenafil and Viagra are backed up by decades of scientific research, no drug is guaranteed to work for everyone and be completely risk-free.
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References:
Dr. Ananya Mandal, M. (2023, June 15). Drug patents and Generic Pharmaceutical Drugs. News. https://www.news-medical.net/health/Drug-Patents-and-Generics.aspx.
Hussar D. A. (2020). Is the Quality of Generic Drugs Cause for Concern?. Journal of Managed Care & Specialty Pharmacy, 26(5), 597–599. https://doi.org/10.18553/jmcp.2020.26.5.597
