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Details for New Drug Application (NDA): 021226

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NDA 021226 describes KALETRA, which is a drug marketed by Abbvie and is included in three NDAs. It is available from nine suppliers. There are twenty 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. Nine suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the lopinavir; ritonavir profile page.

Summary for NDA: 021226

Tradename:
KALETRA
Applicant:
Abbvie
Ingredient:
lopinavir; ritonavir
Patents:9
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength133.3MG;33.3MG
Approval Date:Sep 15, 2000TE:RLD:No
Patent:5,914,332*PEDPatent Expiration:Jun 13, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,037,157*PEDPatent Expiration:Dec 26, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:6,232,333*PEDPatent Expiration:May 7, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021226

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 20005,541,206*PED► subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 20005,846,987*PED► subscribe
Abbvie
KALETRA
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 20005,914,332*PED► subscribe
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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 verifification 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.

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