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Generic Levitra Availability

Last updated on Feb 9, 2023.

Levitra is a brand name of vardenafil, approved by the FDA in the following formulation(s):

LEVITRA (vardenafil hydrochloride – tablet;oral)

Manufacturer: BAYER HLTHCARE
Approval date: August 19, 2003
Strength(s): EQ 2.5MG BASE (discontinued) [RLD], EQ 5MG BASE (discontinued) [RLD], EQ 10MG BASE (discontinued) [RLD], EQ 20MG BASE (discontinued) [RLD]

All of the above formulations have been discontinued.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Levitra. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug’s development and may include a wide range of claims.

Medicaments containing vardenafil hydrochloride trihydrate
Patent 8,273,876
Issued: September 25, 2012
Inventor(s): Serno; Peter & Grunenberg; Alfons & Ohm; Andreas & Bellinghausen; Rainer & Vollers; Eimer & Henck; Jan-Olav
Assignee(s): Bayer Intellectual Property GmbH

The invention relates to a method for producing medicaments that contain vardenafil hydrochloride, essentially as trihydrate in solid form, and to medicaments that can be obtained according to this method.

Patent expiration dates:
- July 23, 2027
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  Patent use: TREATEMENT OF ERECTIILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET
Medicaments containing vardenafil hydrochloride trihydrate
Patent 8,841,446
Issued: September 23, 2014
Assignee(s): Bayer Intellectual Property GmbH

The invention relates to a method for producing medicaments that contain vardenafil hydrochloride, essentially as trihydrate in solid form, and to medicaments that can be obtained according to this method.

Patent expiration dates:
- July 3, 2023
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  Drug product

Glossary

Term
Definition

Drug Patent

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.

Drug Exclusivity

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.

RLD

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.