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Last Updated: April 8, 2020

DrugPatentWatch Database Preview

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 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 021251
Tradename:KALETRA
Applicant:Abbvie
Ingredient:lopinavir; ritonavir
Patents:2
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
Paragraph IV (Patent) Challenges for 021251
Tradename Dosage Ingredient NDA Submissiondate
KALETRA SOLUTION;ORAL lopinavir; ritonavir 021251 2014-06-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength80MG/ML;20MG/ML
Approval Date:Sep 15, 2000TE:AARLD:Yes
Patent:  Start TrialPatent Expiration:May 28, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Nov 28, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021251

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000   Start Trial   Start Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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