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The US patent on the erectile dysfunction drug Levitra, held by Bayer HealthCare Pharmaceuticals, expired on October 31, 2018. Expect to see generic Levitra available in the US soon.
Here’s what you should know about Levitra and its generic, both of whose active ingredient is vardenafil.
How Vardenafil Works
The active ingredient in Levitra is vardenafil hydrochloride, a chemical compound that is a member of a family of drugs known as PDE5 inhibitors. Other popular ED drugs are Viagra and Cialis. Although Bayer collaborated with two other pharmaceutical companies — GlaxoSmithKline and Schering-Plough — to develop the medication, Bayer alone holds the U.S. patent on the medication today.
When a pharmaceutical company or consortium develops a new medication it believes can effectively treat a medical condition, it submits what’s known as a new drug application, or NDA, to the U.S. drug regulatory agency. Such submissions are accompanied by clinical test data intended to show the efficacy of the proposed new drug and the absence of any serious adverse effects.
Advisory Panels Review Applications
These NDAs are usually reviewed first by an advisory panel of the FDA that specializes in the category of medications of the new drug candidate. Once the advisory panel hands down its verdict on the drug, whether yea or nay, the FDA usually — although not always — follows the panel’s recommendation.
The fight to get an NDA approved can be long and tortuous, particularly if the proposed new drug’s benefits have to be weighed against some significant side effects. However, once an NDA is approved by the FDA, the new drug is cleared for sale in U.S. pharmacies. The NDA for Levitra got the green light from the FDA on August 19, 2003, and the drug went on sale not long thereafter.
Assuming that a newly introduced drug delivers promised benefits with a minimal number of adverse side effects, that drug — or more specifically its active ingredient — establishes a reputation of efficacy and safety.
Approval Process for Generics
To market a generic version of the drug, a would-be generic manufacturer submits to the FDA what’s known as an abbreviated new drug application, or ANDA. To win FDA approval for its generic version, the applicant must demonstrate that:
- the proposed generic is “pharmaceutically equivalent” to the brand-name for which it would be an alternative;
- the would-be drugmaker is capable of manufacturing the generic both correctly and consistently;
- the generic’s active ingredient is the same as that in the brand-name drug;
- the proposed generic can deliver a sufficient quantity of the active ingredient to the parts of the body that are being targeted;
- the proposed generic’s inactive ingredients, which need not be identical to those of the brand-name drug, are safe;
- the proposed generic drug does not break down over time;
- the container in which the generic would be shipped and sold is appropriate;
- the generic’s drug information label is the same as that of the brand-name drug; and
- all relevant patents or legal exclusivities have expired.
Levitra Patent Recently Expired in the US
Though the same company that makes Levitra also makes Staxyn, Staxyn will remain on-patent for the time being. The reason is that it is designed to work a bit differently: by dissolving under the tongue instead of being taken with water, like Levitra is. The expiration of Bayer’s Levitra patent will have no effect on its patent production for Staxyn.
As previously noted, Levitra’s active ingredient is vardenafil hydrochloride, which by FDA regulation would have to be the active ingredient in any generic formulation approved for marketing as an alternative to Levitra. Similar in chemical structure to the active ingredients in other ED drugs, such as Viagra (sildenafil citrate), Cialis (tadalafil), and Stendra (avanafil), vardenafil hydrochloride has side effects that are similar to those found in these other drugs.
Common Levitra / Vardenafil Side Effects
The most common side effects of vardenafil hydrochloride are generally mild and tend to disappear altogether upon continued use of the drug. These include back pain, dizziness, flushing, headache, indigestion, and runny or stuffy nose. Although rare, Levitra’s more serious side effects can include a sudden decrease or loss of hearing and/or vision and an erection that lasts for more than four hours. Patients who experience these more serious side effects should seek immediate medical attention.
If you have used Levitra in the past and were pleased by the way it worked for you or you would like to give the ED drug a try, you’ll need a prescription to purchase the brand-name drug. Unless regulations change, you’ll also need a prescription to purchase generic alternatives to Levitra when they become available.
Buy Levitra Locally or Online
You can get a prescription from your regular doctor and have it filled at your neighborhood pharmacy. Alternatively, you can order the drug from a reliable online supplier, such as eDrugstore.com, which has been in business for nearly two decades. If you have a doctor’s prescription, you can fax it or scan and email it along with your order to eDrugstore.
Alternatively, eDrugstore can arrange an online consultation with one of its team of licensed U.S. doctors. The doctor will consider your symptoms and medical history before making a determination about whether Levitra or any other ED drug is appropriate for you. Part of the Secure Medical family of online drugstores, eDrugstore is headquartered in Tempe, Arizona, and sells only FDA-approved drugs that have been sourced from licensed U.S. pharmacies. If the online option appeals to you, click here to access eDrugstore’s Erection Problems page. You can start your order by visiting eDrugstore.com.
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