Details for New Drug Application (NDA): 021906

✉ Email this page to a colleague

NDA 021906 describes KALETRA, which is a drug marketed by Abbvie and is included in three NDAs. It is available from two suppliers. 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. Six suppliers are listed for this compound. Additional details are available on the lopinavir; ritonavir profile page.

Summary for 021906

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

Pharmacology for NDA: 021906

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: 021906

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906	NDA	AbbVie Inc.	0074-0522	0074-0522-60	60 TABLET, FILM COATED in 1 BOTTLE (0074-0522-60)
KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906	NDA	AbbVie Inc.	0074-3008	0074-3008-60	60 TABLET, FILM COATED in 1 BOTTLE (0074-3008-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;50MG
Approval Date:	Oct 28, 2005	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG;25MG
Approval Date:	Nov 9, 2007	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021906

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005	7,364,752*PED	⤷ Subscribe
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	6,703,403*PED	⤷ Subscribe
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005	5,846,987*PED	⤷ Subscribe
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005	6,703,403*PED	⤷ Subscribe
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-001	Oct 28, 2005	5,635,523*PED	⤷ Subscribe
Abbvie	KALETRA	lopinavir; ritonavir	TABLET;ORAL	021906-002	Nov 9, 2007	5,846,987*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.