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Generic Kaletra Availability

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

KALETRA (lopinavir; ritonavir - capsule;oral)

  • Manufacturer: ABBVIE
    Approval date: September 15, 2000
    Strength(s): 133.3MG;33.3MG

KALETRA (lopinavir; ritonavir - solution;oral)

  • Manufacturer: ABBVIE
    Approval date: September 15, 2000
    Strength(s): 80MG/ML;20MG/ML [RLD] [AA]

KALETRA (lopinavir; ritonavir - tablet;oral)

  • Manufacturer: ABBVIE
    Approval date: October 28, 2005
    Strength(s): 200MG;50MG [RLD]
  • Manufacturer: ABBVIE
    Approval date: November 9, 2007
    Strength(s): 100MG;25MG [RLD]

Has a generic version of Kaletra been approved?

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

LOPINAVIR AND RITONAVIR (lopinavir; ritonavir solution;oral)

  • Manufacturer: SILARX PHARMS INC
    Approval date: December 27, 2016
    Strength(s): 80MG/ML;20MG/ML [AA]

Note: No generic formulation of the following products are available.

  • lopinavir; ritonavir - capsule;oral
  • lopinavir; ritonavir - tablet;oral

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: Generic Drug FAQs.

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.

  • 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:
    • 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:
    • 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:
    • 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:
    • December 14, 2027
      ✓ 
      Drug product
    • June 14, 2028
      ✓ 
      Pediatric exclusivity
  • Solid pharmaceutical dosage form
    Patent 8,268,349
    Issued: September 18, 2012
    Inventor(s): Rosenberg; Joerg & Reinhold; Ulrich & Liepold; Bernd & Berndl; Gunther & Breitenbach; Joerg & 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:
    • August 25, 2024
      ✓ 
      Drug product
    • February 25, 2025
      ✓ 
      Pediatric exclusivity
  • Solid pharmaceutical dosage form
    Patent 8,309,613
    Issued: November 13, 2012
    Inventor(s): Rosenberg; Joerg & Reinhold; Ulrich & Liepold; Bernd & Berndl; Gunther & Breitenbach; Joerg & Alani; Laman & Ghosh; Soumojeet
    Assignee(s): AbbVie Inc.
    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:
    • December 24, 2024
      ✓ 
      Patent use: TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
    • June 24, 2025
      ✓ 
      Pediatric exclusivity
  • Solid pharmaceutical dosage formulation
    Patent 8,377,952
    Issued: February 19, 2013
    Assignee(s): Abbott Laboratories
    The present invention provides a pharmaceutical dosage formulation, and more particularly, to a pharmaceutical dosage formulation comprising an HIV protease inhibitor.
    Patent expiration dates:
    • October 22, 2027
      ✓ 
      Patent use: ADMINISTRATION WITHOUT FOOD FOR TREATMENT OF HIV-1 INFECTION
    • April 22, 2028
      ✓ 
      Pediatric exclusivity
  • Solid pharmaceutical dosage form
    Patent 8,399,015
    Issued: March 19, 2013
    Assignee(s): AbbVie Inc.
    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:
    • August 25, 2024
      ✓ 
      Drug product
    • February 25, 2025
      ✓ 
      Pediatric exclusivity
  • Self-emulsifying active substance formulation and use of this formulation
    Patent 8,470,347
    Issued: June 25, 2013
    Assignee(s): AbbVie Deutschland GmbH and Co KG
    The present invention relates to self-emulsifying formulations based on an active ingredient component and a formulation base with a lipid component and with a binder component and to the use of this formulation as dosage form in the life science sector. The invention also describes a process for producing self-emulsifying formulations by mixing the formulation components to form a plastic mixture and, where appropriate, to manufacture the formulations as dosage form advantageously by use of melt extrusion. The formulations spontaneously form emulsions in water or aqueous media.
    Patent expiration dates:
    • September 17, 2026
      ✓ 
      Drug product
    • March 17, 2027
      ✓ 
      Pediatric exclusivity
  • Flavoring systems for pharmaceutical compositions and methods of making such compositions
    Patent 8,501,219
    Issued: August 6, 2013
    Assignee(s): AbbVie Inc.
    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
      ✓ 
      Drug product
  • Solid pharmaceutical dosage form
    Patent 8,691,878
    Issued: April 8, 2014
    Assignee(s): AbbVie Inc.
    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:
    • August 25, 2024
      ✓ 
      Patent use: TREATMENT OF HIV-1 INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
    • February 25, 2025
      ✓ 
      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.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
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