KALETRA Drug Patent Profile

When do Kaletra patents expire, and when can generic versions of Kaletra launch?

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. Six 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 27^th, 2016.

Summary for KALETRA

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	152
Drug Prices:	Drug price information for KALETRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KALETRA
What excipients (inactive ingredients) are in KALETRA?	KALETRA excipients list
DailyMed Link:	KALETRA at DailyMed

See drug prices for KALETRA

Recent Clinical Trials for KALETRA

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

Sponsor	Phase
Oregon Health and Science University	Phase 2
OHSU Knight Cancer Institute	Phase 2
October 6 University	Phase 4

See all KALETRA clinical trials

Pharmacology for KALETRA

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

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
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005	AB	RX	Yes	Yes
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000	AA	RX	Yes	Yes
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	AB	RX	Yes	No

Expired US Patents for KALETRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	KALETRA	lopinavir; ritonavir	CAPSULE;ORAL	021226-001	Sep 15, 2000
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000

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

International Patents for KALETRA

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

Country	Patent Number	Title	Estimated Expiration
Canada	2285119	COMPOSES INHIBITEURS DE PROTESE RETROVIRALE (RETROVIRAL PROTEASE INHIBITING COMPOUNDS)
Israel	94444	Retroviral protease inhibiting compounds pharmaceutical compositions containing them and process for their preparation
European Patent Office	0402646	Composés inhibiteurs de la protease retrovirale (Retroviral protease inhibiting compounds)
Serbia	57378	FORMULACIJA ČVRSTOG OBLIKA DOZIRANJA KOJA SADRŽI LOPINAVIR (A SOLID PHARMACEUTICAL DOSAGE FORMULATION COMPRISING LOPINAVIR)

Supplementary Protection Certificates for KALETRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0674513	C00674513	Switzerland		PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
0674513	C300060	Netherlands		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		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