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
(2 years from now) | Active |
| US8377952 | Solid pharmaceutical dosage formulation |
Oct, 2027
(2 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, 8 months from now) | Active |
|
US8309613 (Pediatric) | Solid pharmaceutical dosage form |
Jun, 2025
(6 months from now) | Active |
|
US8691878 (Pediatric) | Solid pharmaceutical dosage form |
Feb, 2025
(2 months from now) | Active |
|
US8268349 (Pediatric) | Solid pharmaceutical dosage form |
Feb, 2025
(2 months from now) | Active |
|
US8399015 (Pediatric) | Solid pharmaceutical dosage form |
Feb, 2025
(2 months from now) | Active |
| US8309613 | Solid pharmaceutical dosage form |
Dec, 2024
(5 days from now) | Active |
| US8399015 | Solid pharmaceutical dosage form |
Aug, 2024
(3 months ago) |
Expired
|
| US8268349 | Solid pharmaceutical dosage form |
Aug, 2024
(3 months ago) |
Expired
|
| US8691878 | Solid pharmaceutical dosage form |
Aug, 2024
(3 months 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
(3 years ago) |
Expired
|
| US8501219 | Flavoring systems for pharmaceutical compositions and methods of making such compositions |
Nov, 2021
(3 years ago) |
Expired
|
|
US7364752 (Pediatric) | Solid dispersion pharamaceutical formulations |
May, 2021
(3 years ago) |
Expired
|
|
US7432294 (Pediatric) | Pharmaceutical formulations |
Nov, 2020
(4 years ago) |
Expired
|
|
US7141593 (Pediatric) | Pharmaceutical formulations |
Nov, 2020
(4 years ago) |
Expired
|
| US7364752 | Solid dispersion pharamaceutical formulations |
Nov, 2020
(4 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
(7 years ago) |
Expired
|
| US6521651 | Pharmaceutical composition |
Nov, 2017
(7 years ago) |
Expired
|
| US6458818 | Pharmaceutical composition |
Nov, 2017
(7 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
(9 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
(11 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.
Latest 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 |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 06 May, 2024 | US8268349 |
| Expire Patent Critical | 30 Oct, 2023 | US8025899 |
| Maintenance Fee Reminder Mailed Critical | 15 May, 2023 | US8025899 |
| Adjustment of PTA Calculation by PTO | 27 Apr, 2022 | US8025899 |
| Expire Patent Critical | 13 Sep, 2021 | US8501219 |
| Expire Patent Critical | 02 Aug, 2021 | US8470347 (Litigated) |
| Expire Patent Critical | 26 Apr, 2021 | US8399015 |
| Expire Patent Critical | 29 Mar, 2021 | US8377952 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 29 Mar, 2021 | US8501219 |
| Maintenance Fee Reminder Mailed Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
| |||||||||||||||
| Agouron Pharms |
| |||||||||||||||
| Bristol Myers Squibb |
| |||||||||||||||
| Gilead |
| |||||||||||||||
| Gilead Sciences |
| |||||||||||||||
| Gilead Sciences Inc |
| |||||||||||||||
| Glaxosmithkline |
| |||||||||||||||
| Msd Sub Merck |
| |||||||||||||||
| Viiv Hlthcare |
| |||||||||||||||
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 - tablet form for oral use, capsule form for oral use, solution 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 |