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Last Updated: December 7, 2021

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Lopinavir; ritonavir - Generic Drug Details

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What are the generic 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, and Hetero Labs Ltd Iii, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for lopinavir; ritonavir

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

SponsorPhase
AB SciencePhase 2
Christian Medical College and Hospital, Ludhiana, IndiaPhase 3
University of Lagos, NigeriaPhase 3

See all lopinavir; ritonavir clinical trials

Generic filers with tentative approvals for LOPINAVIR; RITONAVIR
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free200MG; 50MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free200MG; 50MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free200MG; 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
Hetero Labs Ltd Iii LOPINAVIR AND RITONAVIR lopinavir; ritonavir TABLET;ORAL 091677-002 Jun 4, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 SOLUTION;ORAL 021251-001 Sep 15, 2000 ⤷  Try it Free ⤷  Try it Free
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 ⤷  Try it Free ⤷  Try it Free
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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