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Levitra, the second erectile dysfunction drug to win FDA approval, remains a popular choice among men with ED. A generic equivalent of the drug should go on sale in the United States soon.
Q: What is Levitra’s active ingredient?
A: The active ingredient in Levitra (and Staxyn) is vardenafil hydrochloride, a chemical compound that’s a member of a family of drugs known as PDE5 inhibitors.
Q: Does Levitra treat all forms of erectile dysfunction?
A: In a word, no. However, it does treat the most common cause of ED, which is insufficient blood flow to the penis. It does so by temporarily optimizing blood flow to the genitals. It will probably do little, if anything, to address ED caused by underlying psychological problems or those associated with traumatic or congenital damage to blood vessels that supply the penis.
Q: Does Levitra offer a cure for erectile dysfunction?
A: The drug offers only temporary relief from underlying physiological barriers, vascular in nature, that make it difficult, if not impossible, to achieve an erection. Its duration of action typically runs from four to six hours.
Q: Will Levitra cause me to develop an erection shortly after the drug is taken?
A: Although the drug makes it possible for you to get and keep an erection for a period of four to six hours or slightly more, it will not cause a spontaneous erection. You will still need to get one the old-fashioned way, through feelings of sexual desire or physical stimulation to your genitals.
Q: Does Levitra have any side effects?
A: Levitra’s side effects are generally mild and often disappear upon continued use of the drug. The most common adverse effects are back pain, dizziness, headache, heartburn, nausea, runny or stuffy nose, and upset stomach. In rare cases, the drug can cause a sudden decrease or loss of hearing or vision or result in erections that last four hours or more. If you should experience these more serious side effects, seek immediate medical attention.
Q: Has the FDA approved generic formulations of vardenafil hydrochloride?
A: Yes. It is not uncommon for generic drugmakers to submit abbreviated new drug applications, or ANDAs, for generic formulations of popular drugs. Although the FDA may give tentative approval to such applications, the approved generic versions cannot be marketed until the applicable patent expires. The earliest Levitra’s U.S. patent will expire is in the closing months of 2018.
What About Generic Levitra?
If you’re a man who has ever used an online search engine to find information about Levitra and other oral ED medications, you almost certainly saw the word “generic” in many of the top search engine results. “Generic” is a great buzzword to people who are looking to purchase prescription drugs because many of us rely on generics to make our health care more affordable.
Pharmaceutical companies produce generic versions of popular drugs as soon as they are legally able to. In the United States, drug companies are not allowed to start selling generic versions of name-brand drugs until the patent for the name-brand drug expires.
With very popular drugs (like Levitra and other prescription drugs for ED), pharmaceutical companies that hold the original patents want to keep those patents for as long as possible to ward off competition and build name recognition for their products.
Status of Bayer’s Patent for Levitra
In the United States, Bayer Healthcare holds the patent for Levitra. In the abstract of the patent, the mechanisms of action and uses for the drug are spelled out as follows:
The compounds [in vardenafil, the active ingredient in Levitra] inhibit cGMP-metabolizing phosphodiesterases and are suitable for use as active compounds in pharmaceuticals, for the treatment of cardiovascular and cerebrovascular disorders and/or disorders of the urogenital system, in particular for the treatment of erectile dysfunction.
Levitra’s U.S. patent was scheduled to expire in late 2018; and reports of generic formulations of the drugs being shipped to the United States in advance of their market introduction were circulating even as this article was written.
The makers of Levitra took a lesson from Pfizer, maker of Viagra, who at first patented only the compound for the active ingredient in Viagra. Once they realized what a huge market there was for Viagra, they obtained a second patent, this one related to the use of the active ingredient specifically for treatment of loss of erection symptoms. Had Pfizer not done this, it would have already lost patent protection in the United States. As a result, the company’s patent on the little blue pill will not expire until April 2020. However, its court-mediated agreement with Teva allowed the generic drugmaker to begin selling its generic formulation of Viagra in December 2017 in return for royalties it must pay to Pfizer until the latter’s patent expires.
Generics Made Outside the US
Pharmaceutical companies in other countries, typically China and India, often reverse-engineer popular name-brand drugs to duplicate and create their own generics. This has happened with Levitra, so if you see ads for “generic Levitra,” you may be looking at a drug that was created in this manner. These drugs may, in fact, have the same active ingredient as Levitra, a compound called vardenafil, and may be sold and consumed in those countries.
However, these manufacturers are not allowed to sell their products in the United States until the patent for the original drug expires. The way some foreign generic Levitra manufacturers get around this is to ship internationally rather than setting up shop in the United States. Unfortunately, this is illegal too.
Importing Non-FDA-Approved Drugs
There are a few very specific instances in which it is legal to import non-FDA-approved drugs into the United States. These cases arise with newer treatments for life-threatening diseases for which the United States has no FDA-approved equivalent, and the medications must be imported under the direction of the U.S. physician who is treating the patient.
Since loss or decline of erectile function isn’t a life-threatening disease, and since Levitra is readily available in the United States, generic Levitra does not qualify for legal importation to the United States. That doesn’t mean that people don’t do it, but it does mean that if you are caught, you could be out of the money you paid and could theoretically get into legal trouble.
Policy on Imported Rx Drugs
You may well know someone who crosses the border into Canada to purchase prescription drugs at lower prices than those offered on the U.S. side of the border. In general, U.S. Customs and Border Protection (CBP) will look the other way when people bring in these medications as long as they have a prescription from a U.S. physician and are only bringing in a 90-day supply or less.
When it comes to generics shipped in from other countries, however, if CBP finds them, it will keep them and probably destroy them. CBP makes over 300 seizures of generic drugs from other countries each year. When you consider the huge numbers of shipments coming into the United States, it’s statistically unlikely that your order will be seized, but it is nevertheless a possibility.
Counterfeit Levitra
One reason the United States tries to ferret out and seize shipments of “generic Levitra” shipped in from other countries is because, in many cases, the product is counterfeit. That means it most likely won’t contain any of the active ingredient found in Levitra, and may in fact contain substances that are dangerous. If you order “generic Levitra” from overseas, you’ll at best end up with something that’s ineffective. At worst, you could ingest something harmful.
Don’t Take Chances
Your best bet if you want to take Levitra (or any of the other popular ED drugs, like Viagra) and get it at a competitive price while having it shipped quickly and discreetly to your home, is to work with a trusted U.S.-based online facilitator such as eDrugstore.com. These companies contract with licensed U.S. physicians and pharmacists to dispense genuine FDA-approved drugs like Levitra. If you don’t have a prescription, eDrugstore will arrange a complimentary online consultation with a licensed U.S. physician who can authorize a prescription if appropriate. The facilitator will ship the product in plain packaging within a few days (or overnight if you choose overnight shipping). To learn more, visit eDrugstore’s Erection Problems page.
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