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Last Updated: March 28, 2024

Lopinavir; ritonavir - Generic Drug Details


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What are the generic drug sources for lopinavir; ritonavir and what is the scope of freedom to operate?

Lopinavir; ritonavir is the generic ingredient in two branded drugs marketed by Abbvie, Lannett Co Inc, Hetero Labs Ltd Iii, Laurus, and Mylan Labs Ltd, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound. There are four tentative approvals for this compound.

Recent Clinical Trials for lopinavir; ritonavir

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of WashingtonPhase 1
University of Wisconsin, MadisonPhase 1
Wisconsin Partnership ProgramPhase 1

See all lopinavir; ritonavir clinical trials

Generic filers with tentative approvals for LOPINAVIR; RITONAVIR
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MG; 50MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial200MG; 50MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial100MG; 25MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for LOPINAVIR; RITONAVIR
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 lopinavir; ritonavir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd Iii LOPINAVIR AND RITONAVIR lopinavir; ritonavir TABLET;ORAL 091677-001 Jun 4, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc LOPINAVIR AND RITONAVIR lopinavir; ritonavir SOLUTION;ORAL 207407-001 Dec 27, 2016 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 AA RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 lopinavir; ritonavir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 ⤷  Try a Trial ⤷  Try a Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 ⤷  Try a Trial ⤷  Try a Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 ⤷  Try a Trial ⤷  Try a Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for lopinavir; ritonavir

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

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