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Last Updated: July 13, 2024

KALETRA Drug Patent Profile


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Which patents cover Kaletra, and what generic alternatives are available?

Kaletra is a drug marketed by Abbvie and is included in three NDAs.

The generic ingredient in KALETRA is lopinavir; ritonavir. There are thirteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the lopinavir; ritonavir profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Kaletra

A generic version of KALETRA was approved as lopinavir; ritonavir by LANNETT CO INC on December 27th, 2016.

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Drug patent expirations by year for KALETRA
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Paragraph IV (Patent) Challenges for KALETRA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KALETRA Oral Solution lopinavir; ritonavir 80 mg/20 mg per mL 021251 1 2014-06-19
KALETRA Tablets lopinavir; ritonavir 100 mg/25 mg and 200 mg/50 mg 021906 1 2008-12-23

US Patents and Regulatory Information for KALETRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 AA RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for KALETRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 ⤷  Sign Up ⤷  Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 ⤷  Sign Up ⤷  Sign Up
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for KALETRA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Lopinavir/Ritonavir Mylan lopinavir, ritonavir EMEA/H/C/004025
Lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.The choice of lopinavir/ritonavir to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.
Authorised yes no no 2016-01-14
AbbVie Deutschland GmbH Co. KG Kaletra lopinavir, ritonavir EMEA/H/C/000368
Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children aged from 14 days and older.The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.
Authorised no no no 2001-03-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for KALETRA

See the table below for patents covering KALETRA around the world.

Country Patent Number Title Estimated Expiration
Chile 2017001847 Una formulación sólida de dosificación farmacéutica ⤷  Sign Up
Peru 20100123 UNA FORMULACION SOLIDA DE DOSIFICACION FARMACEUTICA ⤷  Sign Up
Hong Kong 1012337 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KALETRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0674513 C300060 Netherlands ⤷  Sign Up PRODUCT NAME: RITONAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN FARMACEUTISCH AANVAARDBARE ESTER, EN LOPINAVIR; REGISTRATION NO/DATE: EU/1/01/172/001 - EU/1/01/172/003 20010320
0674513 SPC/GB01/044 United Kingdom ⤷  Sign Up PRODUCT NAME: THE COMBINATION OF THE ACTIVE INGREDIENTS RITONAVIR AND LOPINAVIR; REGISTERED: CH 55649 20001213; UK EU/1/01/172/001 20010320; UK EU/1/01/172/002 20010320; UK EU/1/01/172/003 20010320
0674513 C00674513 Switzerland ⤷  Sign Up PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.