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, Hetero Labs Ltd Iii, Laurus, Macleods Pharms Ltd, and Mylan Labs Ltd, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for LOPINAVIR; RITONAVIR

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	8
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	340
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOPINAVIR; RITONAVIR
DailyMed Link:	LOPINAVIR; RITONAVIR at DailyMed

Recent Clinical Trials for LOPINAVIR; RITONAVIR

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

Sponsor	Phase
University of Washington	Phase 1
Wisconsin Partnership Program	Phase 1
University of Wisconsin, Madison	Phase 1

See all LOPINAVIR; RITONAVIR clinical trials

Generic filers with tentative approvals for LOPINAVIR; RITONAVIR

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	200MG; 50MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	200MG; 50MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	100MG; 25MG	TABLET; ORAL

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

Pharmacology for LOPINAVIR; RITONAVIR

Drug Class	Cytochrome P450 3A Inhibitor Protease Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors P-Glycoprotein Inhibitors UDP Glucuronosyltransferases Inducers

Anatomical Therapeutic Chemical (ATC) Classes for LOPINAVIR; RITONAVIR

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AR	Antivirals for treatment of HIV infections, combinations
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Macleods Pharms Ltd	LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	204739-001	Jul 25, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Laurus	LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	213857-002	Mar 21, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	091677-001	Jun 4, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Laurus	LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	TABLET;ORAL	213857-001	Mar 21, 2022	AB	RX	No	No	⤷ 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
Lannett Co Inc	LOPINAVIR AND RITONAVIR	lopinavir; ritonavir	SOLUTION;ORAL	207407-001	Dec 27, 2016	AA	RX	No	No	⤷ 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 LOPINAVIR; RITONAVIR

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

EU/EMA Drug Approvals for LOPINAVIR; RITONAVIR

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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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