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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 021251

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NDA 021251 describes KALETRA, which is a drug marketed by Abbvie and is included in three NDAs. It is available from one supplier. Additional details are available on the KALETRA profile page.

The generic ingredient in KALETRA is lopinavir; ritonavir. There are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the lopinavir; ritonavir profile page.

Summary for 021251

Tradename:	KALETRA
Applicant:	Abbvie
Ingredient:	lopinavir; ritonavir
Patents:	0

Pharmacology for NDA: 021251

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

Suppliers and Packaging for NDA: 021251

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251	NDA	AbbVie Inc.	0074-3956	0074-3956-46	1 BOTTLE in 1 CARTON (0074-3956-46) / 160 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	80MG/ML;20MG/ML
Approval Date:	Sep 15, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021251

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000	5,914,332*PED	⤷ Get Started Free
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000	5,484,801*PED	⤷ Get Started Free
Abbvie	KALETRA	lopinavir; ritonavir	SOLUTION;ORAL	021251-001	Sep 15, 2000	5,674,882*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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