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Generic Lexiva Availability

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

LEXIVA (fosamprenavir calcium - suspension;oral)

  • Manufacturer: VIIV HLTHCARE
    Approval date: June 14, 2007
    Strength(s): EQ 50MG BASE/ML [RLD]

LEXIVA (fosamprenavir calcium - tablet;oral)

  • Manufacturer: VIIV HLTHCARE
    Approval date: October 20, 2003
    Strength(s): EQ 700MG BASE [RLD] [AB]

Has a generic version of Lexiva been approved?

A generic version of Lexiva 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 Lexiva and have been approved by the FDA:

fosamprenavir calcium tablet;oral

  • Manufacturer: MYLAN PHARMS INC
    Approval date: April 15, 2016
    Strength(s): EQ 700MG BASE [AB]

Note: No generic formulation of the following product is available.

  • fosamprenavir calcium - suspension;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lexiva. 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.

  • Prodrugs of aspartyl protease inhibitors
    Patent 6,436,989
    Issued: August 20, 2002
    Inventor(s): Michael R.; Hale & Roger D.; Tung & Christopher T.; Baker & Andrew; Spaltenstein
    Assignee(s): Vertex Pharmaceuticals, Incorporated
    The present invention relates to prodrugs of a class of sulfonamides which are aspartyl protease inhibitors. In one embodiment, this invention relates to a novel class of prodrugs of HIV aspartyl protease inhibitors characterized by favorable aqueous solubility, high oral bioavailability and facile in vivo generation of the active ingredient. This invention also relates to pharmaceutical compositions comprising these prodrugs. The prodrugs and pharmaceutical compositions of this invention are particularly well suited for decreasing the pill burden and increasing patient compliance. This invention also relates to methods of treating mammals with these prodrugs and pharmaceutical compositions.
    Patent expiration dates:
    • December 24, 2017
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • June 24, 2018
      ✓ 
      Pediatric exclusivity
  • Calcium (3S) tetrahydro-3-furanyl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy)propylcarbamate
    Patent 6,514,953
    Issued: February 4, 2003
    Inventor(s): Ian Gordon; Armitage & Andrew David; Searle & Hardev; Singh
    Assignee(s): SmithKline Beecham Corporation
    The invention relates to calcium (3S) tetrahydro-3-furanyl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-(phosphonooxy)propylcarbamate, to processes for its preparation, and to its use in the treatment of diseases caused by retroviruses.
    Patent expiration dates:
    • July 15, 2019
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 15, 2020
      ✓ 
      Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • October 27, 2015 - PEDIATRIC EXCLUSIVITY

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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