You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Harvard Business School
Medtronic
Baxter
Colorcon

Last Updated: April 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021906


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 021906 describes KALETRA, which is a drug marketed by Abbvie and is included in three NDAs. It is available from three suppliers. There are thirteen patents protecting this drug and two Paragraph IV challenges. 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 021906
Tradename:KALETRA
Applicant:Abbvie
Ingredient:lopinavir; ritonavir
Patents:9
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. 0074-6799 0074-6799-22 120 TABLET, FILM COATED in 1 BOTTLE (0074-6799-22)
Paragraph IV (Patent) Challenges for 021906
Tradename Dosage Ingredient NDA Submissiondate
KALETRA TABLET;ORAL lopinavir; ritonavir 021906 2008-12-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;50MG
Approval Date:Oct 28, 2005TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jan 19, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:May 10, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jun 14, 2028Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021906

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005   Start Trial   Start Trial
>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

Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Harvard Business School
Dow
Medtronic
AstraZeneca

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.