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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Teva
Deloitte
Cipla
Citi
AstraZeneca
Mallinckrodt
Chubb
Federal Trade Commission

Generated: June 19, 2018

DrugPatentWatch Database Preview

KALETRA Drug Profile

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When do Kaletra patents expire, and when can generic versions of Kaletra launch?

Kaletra is a drug marketed by Abbvie and is included in three NDAs. There are sixteen patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-one patent family members in thirty-one countries.

The generic ingredient in KALETRA is lopinavir; ritonavir. There are thirteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the lopinavir; ritonavir profile page.
Drug patent expirations by year for KALETRA
Synonyms for KALETRA
(2S)-N-[(1S,3S,4S)-1-benzyl-4-[[2-(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-pentyl]-3-methyl-2-(2-oxohexahydropyrimidin-1-yl)butanamide; thiazol-5-ylmethyl N-[(1S,2S,4S)-1-benzyl-2-hydroxy-4-[[(2S)-2-[[(2-isopropy
369372-47-4
ABT-378 & ABT-538
Aluvia(TM)
AM023031
D02498
DTXSID30190428
Kaletra(TM)
Lopinavir - ritonavir mixt
Lopinavir / Ritonavir
Lopinavir & Norvir
Lopinavir & Ritonavir
Lopinavir mixture with ritonavir
Lopinavir-Ritonavir mixt
LOPINAVIR; RITONAVIR
Lopinavir/Ritonavir
LPV / RTV
LPV/r
LS-188000
Ritonavir and Lopinavir mixture
Ritonavir-boosted lopinavir
SCHEMBL1506739

US Patents and Regulatory Information for KALETRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 AA RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for KALETRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 ➤ Sign Up ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for KALETRA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Oral Solution 80 mg/20 mg per mL ➤ Subscribe 2014-06-19
➤ Subscribe Tablets 100 mg/25 mg ➤ Subscribe 2008-12-23

Non-Orange Book US Patents for 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
7,183,416 Polymorph of a pharmaceutical ➤ Sign Up
8,193,367 Polymorph of a pharmaceutical ➤ Sign Up
8,674,112 Polymorph of a pharmaceutical ➤ Sign Up
8,895,051 Flavoring systems for pharmaceutical compositions and methods of making such compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for KALETRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/044 United Kingdom ➤ Sign Up PRODUCT NAME: THE COMBINATION OF THE ACTIVE INGREDIENTS RITONAVIR AND LOPINAVIR; REGISTERED: CH 55649 20001213; UK EU/1/01/172/001 20010320; UK EU/1/01/172/002 20010320; UK EU/1/01/172/003 20010320
00060 Netherlands ➤ Sign Up PRODUCT NAME: RITONAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN FARMACEUTISCH AANVAARDBARE ESTER, EN LOPINAVIR; REGISTRATION NO/DATE: EU/1/01/172/001 - EU/1/01/172/003 20010320
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Merck
Farmers Insurance
Cantor Fitzgerald
Queensland Health
Chinese Patent Office
Colorcon
Chubb
Express Scripts

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