Generic Levitra Availability

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

LEVITRA (vardenafil hydrochloride - tablet;oral)

Has a generic version of Levitra been approved?

A generic version of Levitra has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Levitra and have been approved by the FDA:

vardenafil hydrochloride tablet;oral

  • Manufacturer: TEVA PHARMS
    Approval date: May 3, 2012
    Strength(s): 2.5MG [AB], 5MG [AB], 10MG [AB], 20MG [AB]

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.

See also: About generic drugs.

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.

  • 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
    Patent 6,362,178
    Issued: March 26, 2002
    Inventor(s): Ulrich; Niewöhner & Mazen; Es-Sayed & Helmut; Haning & Thomas; Schenke & Karl-Heinz; Schlemmer & Jörg; Keldenich & Erwin; Bischoff & Elisabeth; Perzborn & Klaus; Dembowsky & Peter; Serno & Marc; Nowakowski
    Assignee(s): Bayer Aktiengesellschaft
    The 2-phenyl-substituted imidazotriazinones having short, unbranched alkyl radicals in the 9-position are prepared from the corresponding 2-phenyl-imidazotriazinones by chlorosulphonation and subsequent reaction with the amines. The compounds 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.
    Patent expiration dates:
    • October 31, 2018
      ✓ 
      Patent use: ERECTILE DYSFUNCTION
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      Drug substance
      ✓ 
      Drug product
  • 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors
    Patent 7,696,206
    Issued: April 13, 2010
    Inventor(s): Niewöhner; Ulrich & Es-Sayed; Mazen & Haning; Helmut & Schenke; Thomas & Schlemmer; Karl-Heinz & Keldenich; Jorg & Bischoff; Erwin & Perzborn; Elisabeth & Dembowsky; Klaus & Serno; Peter & Nowakowski; Marc
    Assignee(s): Bayer Schering Pharma Aktiengesellschaft
    The application claims a compound of the formula or a salt, a hydrate, or a hydrate of a salt thereof. The compounds inhibit cGMP-metabolizing phosphodiesterases and are suitable for use as active compounds in pharmaceuticals, for the treatment of erectile dysfunction.
    Patent expiration dates:
    • October 31, 2018
      ✓ 
      Patent use: ERECTILE DYSFUNCTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • 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
      ✓ 
      Patent use: TREATEMENT OF ERECTIILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
ABProducts 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.
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