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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 two Paragraph IV challenges.

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.

Clinical Trials for: KALETRA

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

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

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

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

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

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

Pilot Study of Effect of Kaletra on CD4 Response in HIV Positive (+) Patients With Viral Suppression KIMBO Study
Status: Terminated Condition: HIV

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
TABLET;ORAL021906-001Oct 28, 2005RXYes7,148,359*PED<disabled>Y<disabled>
lopinavir; ritonavir
TABLET;ORAL021906-002Nov 9, 2007RXNo5,648,497*PED<disabled>Y<disabled>
lopinavir; ritonavir
TABLET;ORAL021906-001Oct 28, 2005RXYes5,914,332*PED<disabled>Y<disabled>
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Paragraph IV activity for: KALETRA

Drugname Dosage Strength RLD Submissiondate
lopinavir and ritonavirOral Solution80 mg/20 mg per mLKaletra6/19/2014
lopinavir and ritonavirTablets100 mg/25 mgKaletra12/23/2008

Non-Orange Book Patents for Tradename: KALETRA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,625,072 Retroviral protease inhibiting compounds<disabled in preview>
7,183,416Polymorph of a pharmaceutical<disabled in preview>
6,017,928 Retroviral protease inhibiting compounds<disabled in preview>
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ISSN: 2162-2639

Preferred citation:

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

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