Saturday, 9 April 2011

Kaletra


Kaletra is a brand name of lopinavir/ritonavir, approved by the FDA in the following formulation(s):


KALETRA (lopinavir; ritonavir - capsule; oral)



  • Manufacturer: ABBOTT

    Approval date: September 15, 2000

    Strength(s): 133.3MG;33.3MG [RLD]

KALETRA (lopinavir; ritonavir - solution; oral)



  • Manufacturer: ABBOTT

    Approval date: September 15, 2000

    Strength(s): 80MG/ML;20MG/ML [RLD]

KALETRA (lopinavir; ritonavir - tablet; oral)



  • Manufacturer: ABBOTT

    Approval date: October 28, 2005

    Strength(s): 200MG;50MG [RLD]


  • Manufacturer: ABBOTT

    Approval date: November 9, 2007

    Strength(s): 100MG;25MG

Has a generic version of Kaletra been approved?


No. There is currently no therapeutically equivalent version of Kaletra available.


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




  • Pharmaceutical composition for inhibiting HIV protease
    Patent 5,484,801
    Issued: January 16, 1996
    Inventor(s): Al-Razzak; Laman A. & Marsh; Kennan C. & Manning; Lourdes P. & Kaul; Dilip
    Assignee(s): Abbott Laboratories
    A pharmaceutical composition is disclosed which comprises a solution of an HIV protease inhibiting compound in a pharmaceutically acceptable organic solvent comprising a mixture of (1) (a) a solvent selected from propylene glycol and polyethylene glycol or (b) a solvent selected from polyoxyethyleneglycerol triricinoleate, polyethylene glycol 40 hydrogenated castor oil, fractionated coconut oil, polyoxyethylene (20) sorbitan monooleate and 2-(2-ethoxyethoxy)ethanol or (c) a mixture thereof and (2) ethanol or propylene glycol.
    Patent expiration dates:

    • January 28, 2014
      ✓ 
      Drug product


    • July 28, 2014
      ✓ 
      Pediatric exclusivity




  • Retroviral protease inhibiting compounds
    Patent 5,541,206
    Issued: July 30, 1996
    Inventor(s): Kempf; Dale J. & Norbeck; Daniel W. & Sham; Hing Leung & Zhao; Chen
    Assignee(s): Abbott Laboratories
    A retroviral protease inhibiting compound of the formula: ##STR1## is disclosed.
    Patent expiration dates:

    • July 30, 2013
      ✓ 
      Patent use: METHOD OF USE FOR INHIBITING HIV INFECTION
      ✓ 
      Drug substance


    • July 30, 2013
      ✓ 
      Patent use: METHOD OF USE FOR INHIBITING HIV INFECTION
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • July 30, 2013
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • July 30, 2013
      ✓ 
      Patent use: TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • January 30, 2014
      ✓ 
      Pediatric exclusivity




  • Retroviral protease inhibiting compounds
    Patent 5,648,497
    Issued: July 15, 1997
    Inventor(s): Kempf; Dale J. & Norbeck; Daniel W. & Codacovi; Lynn M. & Sham; Hing L. & Wittenberger; Steven J.
    Assignee(s): Abbott Laboraotries
    A retroviral protease inhibiting compound of the formula A--X--B is disclosed. Also disclosed are a composition and method for inhibiting a retroviral protease and for treating an HIV infection. Also disclosed are processes and intermediates useful for the preparation of the retroviral protease inhibitors.
    Patent expiration dates:

    • July 15, 2014


    • July 15, 2014
      ✓ 
      Drug substance


    • July 15, 2014
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • January 15, 2015
      ✓ 
      Pediatric exclusivity




  • Retroviral protease inhibiting compounds
    Patent 5,886,036
    Issued: March 23, 1999
    Inventor(s): Kempf; Dale J. & Norbeck; Daniel W. & Sham; Hing Leung & Zhao; Chen
    Assignee(s): Abbott Laboratories
    A retroviral protease inhibiting compound of the formula: ##STR1## is disclosed.
    Patent expiration dates:

    • November 19, 2013
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • November 19, 2013
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • May 19, 2014
      ✓ 
      Pediatric exclusivity




  • Retroviral protease inhibiting compounds
    Patent 5,914,332
    Issued: June 22, 1999
    Inventor(s): Sham; Hing Leung & Norbeck; Daniel W. & Chen; Xiaoqi & Betebenner; David A.
    Assignee(s): Abbott Laboratories
    A compound of the formula: ##STR1## is disclosed as an HIV protease inhibitor. Methods and compositions for inhibiting an HIV infection are also disclosed.
    Patent expiration dates:

    • December 13, 2015
      ✓ 
      Patent use: INHIBITING PROTEASE WITH LOPINAVIR AND INHIBITING AN HIV INFECTION WITH LOPINAVIIR


    • December 13, 2015
      ✓ 
      Patent use: INHIBITING PROTEASE WITH LOPINAVIR AND INHIBITING AN HIV INFECTION WITH LOPINAVIIR
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • December 13, 2015
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • December 13, 2015
      ✓ 
      Patent use: TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • June 13, 2016
      ✓ 
      Pediatric exclusivity




  • Pharmaceutical composition
    Patent 5,948,436
    Issued: September 7, 1999
    Inventor(s): Al-Razzak; Laman A. & Marsh; Kennan C. & Kaul; Dilip & Manning; Lourdes P.
    Assignee(s): Abbott Laboratories
    A pharmaceutical composition is disclosed which comprises a solution of an HIV protease inhibiting compound in a pharmaceutically acceptable organic solvent comprising a pharmaceutically acceptable alcohol. The composition can optionally comprise a pharmaceutically acceptable acid or a combination of pharmaceutically acceptable acids. The solution can optionally be encapsulated in hard gelatin capsules or soft elastic gelatin capsules. The solution can optionally be granulated with a pharmaceutically acceptable granulating agent.
    Patent expiration dates:

    • September 13, 2013
      ✓ 
      Drug product


    • March 13, 2014
      ✓ 
      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: METHOD FOR INHIBITING CYTOCHROME P450 MONOOXYGENASE WITH RITONAVIR AND A METHOD FOR IMPROVING THE PHARMCOKINETICS OF A DRUG THAT IS MTABOLIZED BY CYTOCHROME P450 MONOOXYGENASE BY ADMIN THE DRUG AND RITONAVIR


    • June 26, 2016
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS


    • June 26, 2016
      ✓ 
      Patent use: TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS


    • December 26, 2016
      ✓ 
      Pediatric exclusivity




  • Pharmaceutical composition
    Patent 6,232,333
    Issued: May 15, 2001
    Inventor(s): Lipari; John & Al-Razzak; Laman A. & Ghosh; Soumojeet & Gao; Rong & Kaul; Dilip
    Assignee(s): Abbott Laboratories
    A liquid pharmaceutical composition providing improved oral bioavailability is disclosed for compounds which are inhibitors of HIV protease. In particular, the composition comprises a solution in a pharmaceutically acceptable organic solvent of (a) the HIV protease inhibitor and, optionally, (b) a surfactant. The composition can optionally be encapsulated in either hard gelatin capsules or soft elastic capsules (SEC).
    Patent expiration dates:

    • November 7, 2017


    • May 7, 2018
      ✓ 
      Pediatric exclusivity




  • Retroviral protease inhibiting compounds
    Patent 6,284,767
    Issued: September 4, 2001
    Inventor(s): Sham; Hing Leung & Norbeck; Daniel W. & Kempf; Dale J. & Chen; Xiaoqi & Betebenner; David A. & Herrin; Thomas R. & Kumar; Gondi N. & Lipari; John M. & Alani; Laman & Ghosh; Soumojeet & Gao; Rong R. & Kaul; Dilip
    Assignee(s): Abbott Laboratories
    A compound of the formula: ##STR1## is disclosed as an HIV protease inhibitor. Methods and compositions for inhibiting an HIV infection are also disclosed.
    Patent expiration dates:

    • February 15, 2016
      ✓ 
      Patent use: TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
      ✓ 
      Drug product


    • February 15, 2016
      ✓ 
      Patent use: USE OF LOPINAVIR IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS FOR TREATING HIV INFECTION AND IN COMBO WITH OTHER HIV PROTEASE INHIBITORS
      ✓ 
      Drug product


    • February 15, 2016
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
      ✓ 
      Drug product


    • August 15, 2016
      ✓ 
      Pediatric exclusivity




  • Pharmaceutical composition
    Patent 6,458,818
    Issued: October 1, 2002
    Inventor(s): John; Lipari & Laman A.; Al-Razzak & Soumojeet; Ghosh & Rong; Gao & Dilip; Kaul
    Assignee(s): Abbott Laboratories
    A liquid pharmaceutical composition providing improved oral bioavailability is disclosed for compounds which are inhibitors of HIV protease. In particular, the composition comprises a solution in a pharmaceutically acceptable organic solvent of (a) the HIV protease inhibitor and, optionally, (b) a surfactant. The composition can optionally be encapsulated in either hard gelatin capsules or soft elastic capsules (SEC).
    Patent expiration dates:

    • November 7, 2017


    • May 7, 2018
      ✓ 
      Pediatric exclusivity




  • Pharmaceutical composition
    Patent 6,521,651
    Issued: February 18, 2003
    Inventor(s): John; Lipari & Laman A.; Al-Razzak & Soumojeet; Ghosh & Rong; Gao & Dilip; Kaul
    Assignee(s): Abbott Laboratories
    A liquid pharmaceutical composition providing improved oral bioavailability is disclosed for compounds which are inhibitors of HIV protease. In particular, the composition comprises a solution in a pharmaceutically acceptable organic solvent of (a) the HIV protease inhibitor and, optionally, (b) a surfactant. The composition can optionally be encapsulated in either hard gelatin capsules or soft elastic capsules (SEC).
    Patent expiration dates:

    • November 7, 2017
      ✓ 
      Drug product


    • May 7, 2018
      ✓ 
      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 HIV INFECTION


    • June 26, 2016
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS


    • June 26, 2016
      ✓ 
      Patent use: TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS


    • December 26, 2016
      ✓ 
      Pediatric exclusivity




  • Flavoring systems for pharmaceutical compositions and methods of making such compositions
    Patent 6,911,214
    Issued: June 28, 2005
    Inventor(s): Alani; Laman & Gauwitz; Donald P. & Kaul; Dilip & Lipari; John M. & Ghosh; Soumojeet & Marsh; Kennan C. & Whelan; Richard H. & Petrossian; Vanik D.
    Assignee(s): Abbott Laboratories
    A flavoring system for a liquid pharmaceutical composition and pharmaceutical compositions containing such flavoring systems are disclosed. Flavoring systems of the invention include at least one sweetening agent, at least two flavored ingredients, and at least one flavor modifier selected from the group consisting of citric acid, sodium citrate, sodium chloride, and mixtures thereof. At least two of the flavored ingredients are selected from the group consisting of a vanilla flavored ingredient, a peppermint flavored ingredient, a menthol flavored ingredient, a cotton candy flavored ingredient, and mixtures thereof. The one or more sweetening agents comprise glycerin, monoammonium glycyrrhizinate, saccharin sodium, acesulfame potassium, high fructose corn syrup, and/or mixtures thereof. Pharmaceutical compositions of the invention include a flavoring system of the invention, a solvent system, and at least one pharmaceutically active agent, such as lopinavir or derivatives thereof, ritonavir or derivatives thereof, or mixtures thereof. Methods for making such liquid pharmaceutical compositions are also disclosed.
    Patent expiration dates:

    • November 28, 2021
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
      ✓ 
      Drug product


    • May 28, 2022
      ✓ 
      Pediatric exclusivity




  • Pharmaceutical formulations
    Patent 7,141,593
    Issued: November 28, 2006
    Inventor(s): Alani; Laman & Ghosh; Soumojeet
    Assignee(s): Abbott Laboratories
    Improved pharmaceutical compositions are provided comprising one or more solubilized HIV protease inhibiting compounds having improved solubility properties in a medium and/or long chain fatty acid, or mixtures thereof, a pharmaceutically acceptable alcohol, and water.
    Patent expiration dates:

    • May 22, 2020
      ✓ 
      Drug product


    • November 22, 2020
      ✓ 
      Pediatric exclusivity




  • Polymorph of a pharmaceutical
    Patent 7,148,359
    Issued: December 12, 2006
    Inventor(s): Chemburkar; Sanjay R. & Patel; Ketan
    Assignee(s): Abbott Laboratories
    A new crystalline polymorph of ritonavir and methods for its use and preparation are disclosed.
    Patent expiration dates:

    • July 19, 2019
      ✓ 
      Drug product


    • January 19, 2020
      ✓ 
      Pediatric exclusivity




  • Solid dispersion pharamaceutical formulations
    Patent 7,364,752
    Issued: April 29, 2008
    Inventor(s): Fort; James J. & Krill; Steven L. & Law; Devalina & Qiu; Yihong & Porter; William R. & Schmitt; Eric A.
    Assignee(s): Abbott Laboratories
    A pharmaceutical composition is disclosed which comprises a solid dispersion of an HIV protease inhibitor in a water soluble carrier, such as PEG, having enhanced bioavailability and improved dissolution properties. The solid dispersion may optionally be encapsulated in hard gelatin capsules, compressed into a tablet, or may be granulated with a pharmaceutically acceptable granulating agent. Also disclosed are methods of making said solid dispersion and methods of treating an HIV infection employing said solid dispersion.
    Patent expiration dates:

    • November 10, 2020
      ✓ 
      Patent use: TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
      ✓ 
      Drug product


    • May 10, 2021
      ✓ 
      Pediatric exclusivity




  • Pharmaceutical formulations
    Patent 7,432,294
    Issued: October 7, 2008
    Inventor(s): Alani; Laman & Ghosh; Soumojeet
    Assignee(s): Abbott Laboratories
    Improved pharmaceutical compositions are provided comprising one or more solubilized HIV protease inhibiting compounds having improved solubility properties in a medium and/or long chain fatty acid, or mixtures thereof, a pharmaceutically acceptable alcohol, and water.
    Patent expiration dates:

    • May 22, 2020
      ✓ 
      Drug product


    • November 22, 2020
      ✓ 
      Pediatric exclusivity




  • Solid pharmaceutical dosage form
    Patent 8,025,899
    Issued: September 27, 2011
    Inventor(s): Berndl; Gunther & Rosenberg; Joerg & Liepold; Bernd & Breitenbach; Joerg & Reinhold; Ulrich & Alani; Laman & Ghosh; Soumojeet
    Assignee(s): Abbott Laboratories
    A solid pharmaceutical dosage form providing improved oral bioavailability is disclosed for inhibitors of HIV protease. In particular, the dosage form comprises a solid dispersion of at least one HIV protease inhibitor and at least one pharmaceutically acceptable water-soluble polymer and at least one pharmaceutically acceptable surfactant, said pharmaceutically acceptable water-soluble polymer having a Tg of at least about 50° C. Preferably, the pharmaceutically acceptable surfactant has an HLB value of from about 4 to about 10.
    Patent expiration dates:

    • September 26, 2027
      ✓ 
      Drug product


    • March 26, 2028
      ✓ 
      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:
    • April 27, 2013 - ONCE DAILY DOSING REGIMEN IN ADULT PATIENTS WITH LESS THAN THREE LOPINAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS

See also...

  • Kaletra Consumer Information (Drugs.com)
  • Kaletra Consumer Information (Wolters Kluwer)
  • Kaletra Capsules Consumer Information (Wolters Kluwer)
  • Kaletra Solution Consumer Information (Wolters Kluwer)
  • Kaletra Consumer Information (Cerner Multum)
  • Kaletra Advanced Consumer Information (Micromedex)
  • Kaletra AHFS DI Monographs (ASHP)
  • Lopinavir/Ritonavir Consumer Information (Wolters Kluwer)
  • Lopinavir/Ritonavir Capsules Consumer Information (Wolters Kluwer)
  • Lopinavir/Ritonavir Solution Consumer Information (Wolters Kluwer)
  • Lopinavir and ritonavir Consumer Information (Cerner Multum)
  • Lopinavir and ritonavir Advanced Consumer Information (Micromedex)
  • Lopinavir and Ritonavir AHFS DI Monographs (ASHP)
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