Generic Prezista Availability

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

PREZISTA (darunavir ethanolate - suspension;oral)

  • Manufacturer: JANSSEN PRODS
    Approval date: December 16, 2011
    Strength(s): EQ 100MG BASE/ML [RLD]

PREZISTA (darunavir ethanolate - tablet;oral)

  • Manufacturer: JANSSEN PRODS
    Approval date: February 25, 2008
    Strength(s): EQ 600MG BASE
  • Manufacturer: JANSSEN PRODS
    Approval date: December 18, 2008
    Strength(s): EQ 75MG BASE, EQ 150MG BASE
  • Manufacturer: JANSSEN PRODS
    Approval date: November 9, 2012
    Strength(s): EQ 800MG BASE [RLD]

Has a generic version of Prezista been approved?

No. There is currently no therapeutically equivalent version of Prezista available in the United States.

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

  • .alpha.-and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
    Patent 5,843,946
    Issued: December 1, 1998
    Inventor(s): Vazquez; Michael L. & Mueller; Richard A. & Talley; John J. & Getman; Daniel & DeCrescenzo; Gary A. & Freskos; John N.
    Assignee(s): G.D. Searle & Co.
    .alpha.- and .beta.-amino acid hydroxyethylamino sulfonamide compounds are effective as retroviral protease inhibitors, and in particular as inhibitors of HIV protease.
    Patent expiration dates:
    • December 1, 2015
      ✓ 
      Patent use: TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN ADULT PATIENTS
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      Drug product
    • December 1, 2015
      ✓ 
      Patent use: TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
      ✓ 
      Drug product
    • December 1, 2015
      ✓ 
      Patent use: TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • December 1, 2015
      ✓ 
      Patent use: TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
    • December 1, 2015
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      Patent use: TREATMENT OF HIV INFECTION IN ANTIRETROVIRAL TREATMENT-EXPERIENCED ADULT PATIENTS
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      Drug product
    • June 1, 2016
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      Pediatric exclusivity
  • Method for improving pharmacokinetics
    Patent 6,037,157
    Issued: March 14, 2000
    Inventor(s): Norbeck; Daniel W. & Kempf; Dale J. & Leonard; John M. & Bertz; Richard J.
    Assignee(s): Abbott Laboratories
    A method is disclosed for improving the pharmacokinetics of a drug which is metabolized by cytochrome P450 monooxygenase.
    Patent expiration dates:
    • June 26, 2016
      ✓ 
      Patent use: TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
    • June 26, 2016
      ✓ 
      Patent use: TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
    • June 26, 2016
      ✓ 
      Patent use: TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
    • December 26, 2016
      ✓ 
      Pediatric exclusivity
  • .alpha.- and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
    Patent 6,248,775
    Issued: June 19, 2001
    Inventor(s): Vazquez; Michael L. & Mueller; Richard A. & Talley; John J. & Getman; Daniel P. & DeCrescenzo; Gary A. & Freskos; John N. & Bertenshaw; Deborah E. & Heintz; Robert M.
    Assignee(s): G. D. Searle & Co.
    .alpha.- and .beta.-amino acid hydroxyethylamino sulfonamide compounds are effective as retroviral protease inhibitors, and in particular as inhibitors of HIV protease.
    Patent expiration dates:
    • August 13, 2014
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      Drug substance
    • February 13, 2015
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      Pediatric exclusivity
  • Method for improving pharmacokinetics
    Patent 6,703,403
    Issued: March 9, 2004
    Inventor(s): Daniel W.; Norbeck & Dale J.; Kempf & John M.; Leonard & Richard J.; Bertz
    Assignee(s): Abbott Laboratories
    A method is disclosed for improving the pharmacokinetics of a drug which is metabolized by cytochrome P450 monooxygenase.
    Patent expiration dates:
    • June 26, 2016
      ✓ 
      Patent use: TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
    • June 26, 2016
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      Patent use: TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
    • June 26, 2016
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      Patent use: TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
    • December 26, 2016
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      Pediatric exclusivity
  • Fitness assay and associated methods
    Patent 7,470,506
    Issued: December 30, 2008
    Inventor(s): Erickson; John W. & Gulnik; Sergei V. & Mitsuya; Hiroaki & Ghosh; Arun K.
    Assignee(s): The United States of America as represented by the Department of Health and Human Services Board of Trustees of the University of Illinois
    The present invention provides an assay for determining the biochemical fitness of a biochemical species in a mutant replicating biological entity relative to its predecessor. The present invention further provides a continuous fluorogenic assay for measuring the anti-HIV protease activity of protease inhibitor. The present invention also provides a method of administering a therapeutic compound that reduces the chances of the emergence of drug resistance in therapy. The present invention also provides a compound of formula (I) or a pharmaceutically acceptable salt, a prodrug, a composition, or an ester thereof, wherein A is a group of formulas (A), (B), (C) or (D); R1, R2, R3, R5 or R6 is H, or an optionally substituted and/or heteroatom-bearing alkyl, alkenyl, alkynyl, or cyclic group; Y and/or Z are CH2, O, S, SO, SO2, amino, amides, carbamates, ureas, or thiocarbonyl derivatives thereof, optionally substituted with an alkyl, alkenyl, or alkynyl group; n is from 1 to 5; X is a bond, an optionally substituted methylene or ethylene, an amino, O or S; Q is C(O), C(S), or SO2; m is from 0 to 6; R4 is OH, ═O (keto), NH2, or alkylamino, including esters, amides, and salts thereof; and W is C(O), C(S), S(O), or SO2. Optionally, R5 and R6, together with the N—W bond of formula (I), comprises a macrocyclic ring.
    Patent expiration dates:
    • June 23, 2019
      ✓ 
      Patent use: TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER
    • June 23, 2019
      ✓ 
      Patent use: TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
    • June 23, 2019
      ✓ 
      Patent use: TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER
    • December 23, 2019
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      Pediatric exclusivity
  • Pseudopolymorphic forms of a HIV protease inhibitor
    Patent 7,700,645
    Issued: April 20, 2010
    Inventor(s): Vermeersch; Hans Wim Pieter & Thoné; Daniel Joseph Christiaan & Janssens; Luc Donné Marie-Louise
    Assignee(s): Tibotec Pharmaceuticals Ltd.
    New pseudopolymorphic forms of (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-hydroxypropylcarbamate and processes for producing them are disclosed.
    Patent expiration dates:
    • December 26, 2026
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      Drug substance
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      Drug product
    • June 26, 2027
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      Pediatric exclusivity
  • Pseudopolymorphic forms of a HIV protease inhibitor
    Patent 8,518,987
    Issued: August 27, 2013
    Assignee(s): Janssen R&D Ireland
    New pseudopolymorphic forms of (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-hydroxypropylcarbamate and processes for producing them are disclosed.
    Patent expiration dates:
    • February 16, 2024
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      Drug substance
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      Drug product
    • August 16, 2024
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      Pediatric exclusivity
  • Method of treating HIV infection
    Patent 8,597,876
    Issued: December 3, 2013
    Assignee(s): The United States of America, as represented by the Secretary, Department of Health and Human Services Board of Trustees of the University of Illinois
    Disclosed is a method of treating human immunodeficiency virus (HIV) infection in an antiretroviral treatment-experienced mammal, which involves administering to the mammal an effective amount of a compound of the formula: or a pharmaceutically acceptable salt, a prodrug, or an ester thereof, or a pharmaceutically acceptable composition of the compound, the salt, the prodrug, or the ester thereof, wherein A, X, Q, W, m, and R2-R6 are as defined herein.
    Patent expiration dates:
    • June 23, 2019
      ✓ 
      Patent use: TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
    • December 23, 2019
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      Pediatric exclusivity
  • α- and β- amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
    Patent RE42889
    Issued: November 1, 2011
    Inventor(s): Vazquez; Michael L. & Mueller; Richard A. & Talley; John J. & Getman; Daniel P. & DeCrescenzo; Gary A. & Freskos; John N. & Heintz; Robert M. & Bertenshaw; Deborah E.
    Assignee(s): G.D. Searle LLC
    α- and β-amino acid hydroxyethylamino sulfonamide compounds are effective as retroviral protease inhibitors, and in particular as inhibitors of HIV protease.
    Patent expiration dates:
    • October 19, 2016
      ✓ 
      Drug product
    • April 19, 2017
      ✓ 
      Pediatric exclusivity
  • α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
    Patent RE43596
    Issued: August 21, 2012
    Inventor(s): Vazquez; Michael L. & Mueller; Richard A. & Talley; John J. & Getman; Daniel P. & DeCrescenzo; Gary A. & Freskos; John N. & Heintz; Robert M. & Bertenshaw; Deborah E.
    Assignee(s): G.D. Searle LLC
    α- and β-amino acid hydroxyethylamino sulfonamide compounds are effective as retroviral protease inhibitors, and in particular as inhibitors of HIV protease.
    Patent expiration dates:
    • May 9, 2017
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      Drug substance
      ✓ 
      Drug product
    • November 9, 2017
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      Pediatric exclusivity
  • α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
    Patent RE43802
    Issued: November 13, 2012
    Inventor(s): Vazquez; Michael L. & Mueller; Richard A. & Talley; John J. & Getman; Daniel P. & DeCrescenzo; Gary A. & Freskos; John N. & Bertenshaw; Deborah E. & Heintz; Robert M.
    Assignee(s): G.D. Searle LLC
    α- and β-amino acid hydroxyethylamino sulfonamide compounds are effective as retroviral protease inhibitors, and in particular as inhibitors of HIV protease.
    Patent expiration dates:
    • October 19, 2016
      ✓ 
      Patent use: TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR (PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
    • April 19, 2017
      ✓ 
      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:
    • December 13, 2013 - 800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1 INFECTED PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS
    • June 13, 2014 -
    • December 16, 2014 -
    • December 16, 2014 -
    • June 16, 2015 -
    • February 1, 2016 - UPDATE LABELING WITH ONCE DAILY DOSING IN HIV-1 INFECTED, TREATMENT-NAIVE PEDIATRIC PATIENTS 12 TO LESS THAN 18 YEARS OF AGE
    • August 1, 2016 -

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.
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