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Last Updated: November 13, 2019

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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 and Lannett Co Inc, and is included in four NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lopinavir; ritonavir has seventy-three patent family members in thirty-nine countries.

There are thirteen drug master file entries for lopinavir; ritonavir. Five suppliers are listed for this compound. There are six tentative approvals for this compound.

Recent Clinical Trials for lopinavir; ritonavir

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

SponsorPhase
AMS-PHPT Research Platform (Program for HIV Prevention and Treatment)Phase 1/Phase 2
Institute of Tropical Medicine, BelgiumPhase 1/Phase 2
Drugs for Neglected DiseasesPhase 1/Phase 2

See all lopinavir; ritonavir clinical trials

Recent Litigation for lopinavir; ritonavir

Identify potential future generic entrants

District Court Litigation
Case NameDate
AbbVie Inc. v. Cipla Limited2017-11-10
AbbVie Inc. v. Aurobindo Pharma Limited2017-01-13
AbbVie Inc. v. Amneal Pharmaceuticals, LLC2016-05-27

See all lopinavir; ritonavir litigation

Generic filers with tentative approvals for LOPINAVIR; RITONAVIR
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MG; 50MGTABLET; ORAL
  Start Trial  Start Trial200MG; 50MGTABLET; ORAL
  Start Trial  Start Trial200MG; 50MGTABLET; 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 NDA Submissiondate
KALETRA SOLUTION;ORAL lopinavir; ritonavir 021251 2014-06-19
KALETRA TABLET;ORAL lopinavir; ritonavir 021906 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
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 RX Yes No   Start Trial   Start Trial Y   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 RX Yes No   Start Trial   Start Trial Y   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 RX Yes No   Start Trial   Start Trial Y   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 RX Yes No   Start Trial   Start Trial Y   Start 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   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for lopinavir; ritonavir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0674513 SPC/GB01/044 United Kingdom   Start Trial 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 C300060 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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