Patent expiration dates:

Patent use: ERECTILE DYSFUNCTION

Patent expiration dates:

Patent use: TREATEMENT OF ERECTIILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Patent expiration dates:

A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.

Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.

A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e. identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e. AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Generic Levitra

There is currently no generic version of Levitra available. Levitra is protected by a patent that prevents any generic versions from being manufactured. However, it is expected that once Levitra goes off patent, several companies will start manufacturing a generic form of the drug. The first patent for Levitra currently expires in 2018.

An Overview of Generic Levitra

Levitra ® (vardenafil HCL) is a prescription medicine that is licensed for treating erectile dysfunction (ED ). Levitra is manufactured by Bayer Pharmaceuticals and is currently protected by a patent that prevents any generic Levitra from being manufactured. Yet, if you search the Internet for "generic Levitra," you may find a number of companies selling it. The fact is that these medicines are fake, substandard, and potentially dangerous. There may be generic Levitra available from another country, but there is really no way of knowing if you are getting genuine Levitra or not. You should not buy any generic Levitra until there is an approved generic available.

When Will There Be a Generic Version?

The first patent for Levitra currently expires in 2018. This is the earliest possible date that a generic version of Levitra could become available. However, there are other circumstances that could come up to extend the exclusivity period of Levitra beyond 2018. These circumstances could include such things as other patents for specific Levitra uses or lawsuits. Once Levitra goes off patent, there may be several companies that manufacture a generic Levitra drug.

Is Vardenafil HCL a Generic Levitra?

No. Vardenafil HCL is the active ingredient in Levitra, not a generic version of the drug. Although people often refer to a drug's active ingredient as its "generic name," the generic name of a drug is different than a generic version of it. In order for there to be a generic version of a medicine, the original medicine must have gone off patent, and another company (besides the original manufacturer) must have made the product.

Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD

Last reviewed by: Kristi Monson, PharmD;

Generic Vardenafil

Because vardenafil is currently protected by a patent that prevents a generic form of the drug from being manufactured, no generic vardenafil drug is available at this time. However, once vardenafil goes off patent, it is expected that several companies will start manufacturing a generic version of the medicine. The first patent for vardenafil currently expires in 2018.

Generic Vardenafil: An Overview

Vardenafil HCl (Levitra ®. Staxyn ™) is a prescription medicine that is licensed for treating erectile dysfunction (ED ). It comes as regular tablets (Levitra) or in orally disintegrating tablets (Staxyn) that can be taken without any liquids.

Levitra and Staxyn are both manufactured by Bayer HealthCare Pharmaceuticals, Inc. They are marketed by GlaxoSmithKline and distributed by Schering Corporation. Both medications are protected by patents that prevent any generic vardenafil from being manufactured.

When Will There Be a Generic Vardenafil?

The first patent for vardenafil currently expires in 2018. This is the earliest possible date that a generic version of vardenafil could become available. However, there are other circumstances that could come up to extend the exclusivity period of vardenafil beyond 2018. These circumstances could include such things as other patents for specific vardenafil uses or lawsuits. Once vardenafil goes off patent, there may be several companies that manufacture a generic vardenafil drug.

Is Vardenafil HCl a Generic Levitra?

No. Vardenafil HCl is the active ingredient in Levitra and Staxyn, not a generic version of the drug. Although people often refer to a drug's active ingredient as its "generic name," the generic name of a drug is different than a generic version of it. In order for there to be a generic version of a medicine, the original medicine must have gone off patent and another company (besides the original manufacturer) must have made the product.

Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD

Last reviewed by: Kristi Monson, PharmD;

URL сайта: