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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 twelve 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

lopinavir; ritonavir
Therapeutic Class:Antivirals

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 20005,846,987*PED<disabled>
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 20005,541,206*PED<disabled>
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 20005,948,436*PED<disabled>
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