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Profile for Tradename: KALETRA

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Kaletra is a drug marketed by Abbvie and is included in three NDAs. It is available from seven suppliers. There are twenty-two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in KALETRA is lopinavir; ritonavir. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the lopinavir; ritonavir profile page.

Summary for Tradename: KALETRA

Suppliers: see list7
Formulation / Manufacturing:see details

Clinical Trials for: KALETRA

GSK706769/KALETRA Drug-drug Interaction Study
Status: Completed Condition: Healthy Subjects; Infection, Human Immunodeficiency Virus

Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
Status: Completed Condition: HIV Infections

Lopinavir Capsules to Kaletra or Invirase Tablets
Status: Completed Condition: HIV Infections

KONCERT A Kaletra ONCE Daily Randomised Trial of the Pharmacokinetics, Safety and Efficacy of Twice-daily Versus Once-daily Lopinavir/Ritonavir Tablets Dosed by Weight as Part of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18)
Status: Completed Condition: Antiretroviral Therapy in HIV-1 Infected Children

Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Lopinavir/Ritonavir; Healthy Volunteers

The Effect of Pregnancy on the Pharmacokinetics of the Kaletra Tablet
Status: Completed Condition: Pregnancy; HIV

Evaluation of Kaletra Therapy Over the Long-term
Status: Completed Condition: Human Immunodeficiency Virus

Lopinavir/Ritonavir (Kaletra) PK in Children
Status: Completed Condition: HIV/AIDS Treatment; HIV Infections

Metabolic Effects of Switching Kaletra to Boosted Reyataz
Status: Completed Condition: HIV Infections

Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients
Status: Completed Condition: HIV Infection

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000RXYes6,703,403*PED<disabled>Y<disabled>
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000RXYes6,521,651*PED<disabled>Y<disabled>
lopinavir; ritonavir
SOLUTION;ORAL021251-001Sep 15, 2000RXYes5,484,801*PED<disabled><disabled>
lopinavir; ritonavir
CAPSULE;ORAL021226-001Sep 15, 2000RXYes6,458,818*PED<disabled>Y<disabled>
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007RXNo8,691,878*PED<disabled>Y<disabled>
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Paragraph IV activity for: KALETRA

Drugname Dosage Strength RLD Submissiondate
lopinavir and ritonavirTablets100 mg/25 mgKaletra12/23/2008
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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