Kaletra Patent Expiration

Kaletra is a drug owned by Abbvie Inc. It is protected by 49 US drug patents filed from 2013 to 2014. Out of these, 11 drug patents are active and 38 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 14, 2028. Details of Kaletra's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8025899

(Pediatric)

Solid pharmaceutical dosage form
Jun, 2028

(3 years from now)

Active
US8377952

(Pediatric)

Solid pharmaceutical dosage formulation
Apr, 2028

(3 years from now)

Active
US8025899 Solid pharmaceutical dosage form
Dec, 2027

(3 years from now)

Active
US8377952 Solid pharmaceutical dosage formulation
Oct, 2027

(3 years from now)

Active
US8470347

(Pediatric)

Self-emulsifying active substance formulation and use of this formulation
Mar, 2027

(2 years from now)

Active
US8470347 Self-emulsifying active substance formulation and use of this formulation
Sep, 2026

(1 year, 11 months from now)

Active
US8309613

(Pediatric)

Solid pharmaceutical dosage form
Jun, 2025

(8 months from now)

Active
US8691878

(Pediatric)

Solid pharmaceutical dosage form
Feb, 2025

(4 months from now)

Active
US8268349

(Pediatric)

Solid pharmaceutical dosage form
Feb, 2025

(4 months from now)

Active
US8399015

(Pediatric)

Solid pharmaceutical dosage form
Feb, 2025

(4 months from now)

Active
US8309613 Solid pharmaceutical dosage form
Dec, 2024

(2 months from now)

Active
US8399015 Solid pharmaceutical dosage form
Aug, 2024

(a month ago)

Expired
US8268349 Solid pharmaceutical dosage form
Aug, 2024

(a month ago)

Expired
US8691878 Solid pharmaceutical dosage form
Aug, 2024

(a month ago)

Expired
US6911214

(Pediatric)

Flavoring systems for pharmaceutical compositions and methods of making such compositions
May, 2022

(2 years ago)

Expired
US6911214 Flavoring systems for pharmaceutical compositions and methods of making such compositions
Nov, 2021

(2 years ago)

Expired
US8501219 Flavoring systems for pharmaceutical compositions and methods of making such compositions
Nov, 2021

(2 years ago)

Expired
US7364752

(Pediatric)

Solid dispersion pharamaceutical formulations
May, 2021

(3 years ago)

Expired
US7432294

(Pediatric)

Pharmaceutical formulations
Nov, 2020

(3 years ago)

Expired
US7141593

(Pediatric)

Pharmaceutical formulations
Nov, 2020

(3 years ago)

Expired
US7364752 Solid dispersion pharamaceutical formulations
Nov, 2020

(3 years ago)

Expired
US7141593 Pharmaceutical formulations
May, 2020

(4 years ago)

Expired
US7432294 Pharmaceutical formulations
May, 2020

(4 years ago)

Expired
US7148359

(Pediatric)

Polymorph of a pharmaceutical
Jan, 2020

(4 years ago)

Expired
US7148359 Polymorph of a pharmaceutical
Jul, 2019

(5 years ago)

Expired
US6521651

(Pediatric)

Pharmaceutical composition
May, 2018

(6 years ago)

Expired
US6232333

(Pediatric)

Pharmaceutical composition
May, 2018

(6 years ago)

Expired
US6458818

(Pediatric)

Pharmaceutical composition
May, 2018

(6 years ago)

Expired
US6232333 Pharmaceutical composition
Nov, 2017

(6 years ago)

Expired
US6521651 Pharmaceutical composition
Nov, 2017

(6 years ago)

Expired
US6458818 Pharmaceutical composition
Nov, 2017

(6 years ago)

Expired
US6703403

(Pediatric)

Method for improving pharmacokinetics
Dec, 2016

(7 years ago)

Expired
US6037157

(Pediatric)

Method for improving pharmacokinetics
Dec, 2016

(7 years ago)

Expired
US6284767

(Pediatric)

Retroviral protease inhibiting compounds
Aug, 2016

(8 years ago)

Expired
US6703403 Method for improving pharmacokinetics
Jun, 2016

(8 years ago)

Expired
US6037157 Method for improving pharmacokinetics
Jun, 2016

(8 years ago)

Expired
US5914332

(Pediatric)

Retroviral protease inhibiting compounds
Jun, 2016

(8 years ago)

Expired
US6284767 Retroviral protease inhibiting compounds
Feb, 2016

(8 years ago)

Expired
US5914332 Retroviral protease inhibiting compounds
Dec, 2015

(8 years ago)

Expired
US5648497

(Pediatric)

Retroviral protease inhibiting compounds
Jan, 2015

(9 years ago)

Expired
US5484801

(Pediatric)

Pharmaceutical composition for inhibiting HIV protease
Jul, 2014

(10 years ago)

Expired
US5648497 Retroviral protease inhibiting compounds
Jul, 2014

(10 years ago)

Expired
US5886036

(Pediatric)

Retroviral protease inhibiting compounds
May, 2014

(10 years ago)

Expired
US5948436

(Pediatric)

Pharmaceutical composition
Mar, 2014

(10 years ago)

Expired
US5541206

(Pediatric)

Retroviral protease inhibiting compounds
Jan, 2014

(10 years ago)

Expired
US5484801 Pharmaceutical composition for inhibiting HIV protease
Jan, 2014

(10 years ago)

Expired
US5886036 Retroviral protease inhibiting compounds
Nov, 2013

(10 years ago)

Expired
US5948436 Pharmaceutical composition
Sep, 2013

(11 years ago)

Expired
US5541206 Retroviral protease inhibiting compounds
Jul, 2013

(11 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Kaletra's patents.

Given below is the list of recent legal activities going on the following patents of Kaletra.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 06 May, 2024 US8268349
Expire Patent 30 Oct, 2023 US8025899
Maintenance Fee Reminder Mailed 15 May, 2023 US8025899
Adjustment of PTA Calculation by PTO 27 Apr, 2022 US8025899
Expire Patent 13 Sep, 2021 US8501219
Expire Patent 02 Aug, 2021 US8470347 (Litigated)
Expire Patent 26 Apr, 2021 US8399015
Expire Patent 29 Mar, 2021 US8377952 (Litigated)
Maintenance Fee Reminder Mailed 29 Mar, 2021 US8501219
Maintenance Fee Reminder Mailed 15 Feb, 2021 US8470347 (Litigated)


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Kaletra and ongoing litigations to help you estimate the early arrival of Kaletra generic.

Kaletra's Litigations

Kaletra been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 17, 2009, against patent number US8470347. The petitioner , challenged the validity of this patent, with Gunther Berndl et al as the respondent. Click below to track the latest information on how companies are challenging Kaletra's patents.

Last updated on October 1, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8470347 August, 2009 Decision
(27 May, 2010)
Gunther Berndl et al


FDA has granted some exclusivities to Kaletra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kaletra, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Kaletra.

Exclusivity Information

Kaletra holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Kaletra's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Dosing Schedule(D-124) Apr 27, 2013

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Kaletra is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Kaletra's family patents as well as insights into ongoing legal events on those patents.

Kaletra's Family Patents

Kaletra has patent protection in a total of 37 countries. It's US patent count contributes only to 18.1% of its total global patent coverage. 14 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Kaletra.

Family Patents

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Generic Launch

Generic Release Date:

Kaletra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 14, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Kaletra Generics:

Lopinavir; Ritonavir is the generic name for the brand Kaletra. 5 different companies have already filed for the generic of Kaletra, with Hetero Labs Ltd Iii having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kaletra's generic

How can I launch a generic of Kaletra before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Kaletra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kaletra's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Kaletra -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
100 mg/25 mg and 200 mg/50 mg 23 Dec, 2008 1 10 Nov, 2020 Extinguished
80 mg/20 mg per mL 19 Jun, 2014 1 27 Dec, 2016 28 Nov, 2021 Deferred

Alternative Brands for Kaletra

Kaletra which is used for treating HIV-1 infection in combination with other antiretroviral agents., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Abbvie
Norvir Used for treating HIV infection in combination with other antiretroviral agents.
Agouron Pharms
Viracept Used for managing HIV infection.
Bristol Myers Squibb
Sustiva used for managing HIV infection in combination with other antiviral drugs.
Gilead
Emtriva Used for treating HIV infection in adults.
Truvada Used for treating HIV-1 infection in adults and pediatric patients.
Gilead Sciences
Atripla Used for managing HIV-1 infection in adults and pediatric patients aged 12 years and older.
Gilead Sciences Inc
Descovy Used for managing and treating HIV infection.
Genvoya Used for treating HIV infection with a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monoxygenase.
Odefsey Used for treating HIV infection.
Vitekta Used for managing HIV infection.
Biktarvy Used for treating HIV infection.
Complera Used for managing and treating HIV infection.
Stribild Used for treating HIV infection by enhancing the pharmacokinetics and inhibiting cytochrome P450 monooxygenase.
Glaxosmithkline
Agenerase Used for managing HIV infection.
Msd Sub Merck
Isentress Used for treating HIV infection by inhibiting integrase.
Isentress Hd Used for treating HIV infection.
Viiv Hlthcare
Dovato Used for the treatment of HIV infection.
Juluca Used for managing HIV infection.
Lexiva Used for managing and treating HIV infection.
Epzicom Used for treating HIV infection.





About Kaletra

Kaletra is a drug owned by Abbvie Inc. It is used for treating HIV-1 infection in combination with other antiretroviral agents. Kaletra uses Lopinavir; Ritonavir as an active ingredient. Kaletra was launched by Abbvie in 2007.

Approval Date:

Kaletra was approved by FDA for market use on 09 November, 2007.

Active Ingredient:

Kaletra uses Lopinavir; Ritonavir as the active ingredient. Check out other Drugs and Companies using Lopinavir; Ritonavir ingredient

Treatment:

Kaletra is used for treating HIV-1 infection in combination with other antiretroviral agents.

Dosage:

Kaletra is available in the following dosage forms - solution form for oral use, tablet form for oral use, capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG;50MG TABLET Prescription ORAL
100MG;25MG TABLET Prescription ORAL
80MG/ML;20MG/ML SOLUTION Prescription ORAL
133.3MG;33.3MG CAPSULE Discontinued ORAL