{"id":9859,"date":"2017-08-21T08:00:25","date_gmt":"2017-08-21T08:00:25","guid":{"rendered":"https:\/\/www.edrugstore.com\/blog\/?p=9859"},"modified":"2018-11-13T17:22:25","modified_gmt":"2018-11-13T17:22:25","slug":"generic-levitra-what-you-need-to-know","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/erectile-dysfunction\/levitra\/generic-levitra-what-you-need-to-know\/","title":{"rendered":"Generic Levitra: What You Need to Know"},"content":{"rendered":"

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.<\/em><\/p>\n

Here’s what you should know about Levitra and its generic, both of whose active ingredient is vardenafil.<\/p>\n

How Vardenafil Works<\/h3>\n

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<\/strong>. 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.<\/p>\n

When a pharmaceutical company or consortium develops a new medication it believes can effectively treat a medical condition, it submits what\u2019s 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.<\/p>\n

Advisory Panels Review Applications<\/h3>\n

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\u2019s recommendation.<\/p>\n

The fight to get an NDA approved can be long and tortuous, particularly if the proposed new drug\u2019s 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.<\/p>\n

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.<\/p>\n

Approval Process for Generics<\/h3>\n

To market a generic version of the drug, a would-be generic manufacturer submits to the FDA what\u2019s known as an abbreviated new drug application, or ANDA. To win FDA approval<\/a> for its generic version, the applicant must demonstrate that:<\/p>\n