What: Generic Viagra
When: Goes on sale December 11, 2017
Where: US pharmacies
Why: It will contain the same active ingredient as Viagra and cost less
For American men suffering from erectile dysfunction, the countdown has begun to the arrival of generic Viagra, a product with the same active ingredient — sildenafil citrate — as the little blue pill but at a lower price. Earlier this year, the Food and Drug Administration gave its final approval to a generic version of the drug, but it won’t go on sale until December 11, 2017.
Actually, Pfizer’s U.S. patent on Viagra doesn’t expire until April 2020, but under an agreement it reached with Israeli-based Teva Pharmaceuticals in December 2013, the latter will be the first to market a generic version of Viagra in the United States. Because Pfizer’s patent still will remain in force, Teva will pay a royalty to Pfizer until 2020 under the terms of its licensing agreement with the giant U.S. drugmaker.
Mylan Generic Also on the Horizon
Under the terms of a 2015 patent litigation settlement between Pfizer and Mylan, another prominent generic drug manufacturer, the latter could also begin marketing a generic version of Viagra as early as December 2017. It too would be required to pay a royalty to Pfizer until the April 2020 expiration of Pfizer’s U.S. patent on the drug.
Once Pfizer’s patent on Viagra expires in 2020, other generic versions of the drug will undoubtedly follow, but Teva and Mylan appear poised to be the first to tap the burgeoning demand for a lower-priced erectile dysfunction drug in this country. Generic versions of Viagra are already legally available in a number of other world markets, including Canada, China, and most countries of the European Union.
Some Online Vendors Unscrupulous
Anyone who searches the Internet for “generic Viagra” will find links to literally thousands of websites that purport to offer generic formulations of the drug. Unless you know the reputation of a particular vendor, you have no real guarantee that what it’s selling is the genuine article. Furthermore, because Pfizer’s patent for Viagra remains in force, buying a generic — even if it’s the real thing — is illegal under U.S. law.
Websites based outside the United States might offer genuine tablets containing sildenafil citrate, which by definition is generic Viagra, but it’s illegal for a U.S. citizen to receive prescription drugs without a prescription from a licensed U.S. physician. And physicians in the United States cannot write prescriptions for drugs that are not yet legally available in this country.
What FDA Approval Covers
FDA’s approval of generic Viagra covers sildenafil citrate tablets of 25, 50, and 100 milligrams. Although the recommended starting dose of the drug is 50 milligrams, which produces satisfactory results for most men, some find they can get by with the smaller dose, while others need the stronger dose to get and keep an erection.
The generic versions of Viagra will contain the same active ingredient as the little blue pill and will be available in identical strengths, so there is no reason to believe that these sildenafil citrate pills will work any differently than Viagra itself. As with all the brand-name oral ED medications except Cialis for daily use, the Viagra generics will be for use as needed. That is to say that they are to be taken 15 to 60 minutes before sexual activity and that their effects will in most cases last no more than four to six hours.
How Sildenafil Citrate Works
Like Viagra, these generic pills are designed to temporarily overcome the symptoms of erectile dysfunction caused by insufficient blood flow to the penis, which accounts for about 80 percent of all ED. Neither Viagra nor its generic alternatives are likely to be effective in cases where impotence is due to psychological factors, such as extreme anxiety or depression. Men who believe their ED symptoms are psychological in origin should seek appropriate professional counseling to get to the root of such problems.
Viagra and the other brand-name oral ED medications belong to a family of drugs known as PDE5 inhibitors, so called because they can temporarily disable an enzyme known as phosphodiesterase-5, or PDE5 for short. The Viagra generics, when they come to market, will fall into the same classification of drugs.
Disables PDE5 Enzyme
By temporarily holding the PDE5 enzyme at bay, this group of drugs facilitates the erection process, which depends on a substance known as cyclic guanosine monophosphate, or cGMP, to optimize blood flow. It accomplishes this by relaxing the smooth muscles that line the arteries supplying blood to the penis. In men whose blood flow has already been compromised by atherosclerosis or other physiological causes, cGMP can be prevented from doing its job by the PDE5 enzyme, which breaks down cGMP faster than it can be replaced.
Viagra’s effects wear off after four or five hours, after which time the PDE5 enzyme is once again free to break down cGMP as usual. But the PDE5 inhibitors do open a window of time during which impotent men can get and keep an erection without any interference from the pesky PDE5 enzyme.
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While clinical trials have shown Viagra and future generic versions to be safe and effective in most men, some impotence sufferers might find that these drugs don’t work for them or have unpleasant side effects. In such cases, they will have to talk to their doctors about alternative ED treatments, which include penile injection therapy, vacuum erection devices, and penile implants.
The side effects of sildenafil citrate are generally mild and may disappear altogether as a patient continues to use the drug. These side effects can include back and muscle pain, dizziness, flushing of face, neck, or chest, headache, nasal congestion, nausea, and upset stomach. More serious side effects have been observed, but they are rare. These include a sudden loss of hearing or vision and an erection that lasts for four hours or more. Should you experience one of these side effects, you should seek immediate medical attention.
Potential Drug Interactions
Sildenafil citrate can interact adversely with a number of medications, most of which blunt the effectiveness of the ED drug, or vice versa. Among the drugs that don’t mix well with sildenafil citrate are certain antihypertensive drugs, antidepressants, antihistamines, and alpha blockers that are taken for prostate problems. Check with your doctor to see if any of the medications you’re now taking are known to interact with sildenafil citrate.
An absolute no-no for men taking sildenafil citrate or any other ED drug is concurrent use of nitrate-based drugs, such as those taken to relieve the discomfort of angina. Nitrates are also the primary ingredient in poppers, which are used primarily for recreational purposes. Both nitrates and sildenafil citrate depress blood pressure. When taken together, they can lower blood pressure to potentially life-threatening levels.
As noted earlier, the first Viagra generics won’t show up in U.S. pharmacies until the end of 2017. However, if you’d like to learn more about erectile dysfunction and the drugs that treat it or perhaps order a brand-name ED drug, pay a visit to our Erectile Dysfunction Page.
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