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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Teva
Fish and Richardson
Harvard Business School
Farmers Insurance
QuintilesIMS
Queensland Health
Julphar
UBS

Generated: December 17, 2018

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KALETRA Drug Profile

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Which patents cover Kaletra, and what generic alternatives are available?

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. Eight 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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 AA RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 SOLUTION;ORAL 021251-001 Sep 15, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir SOLUTION;ORAL 021251-001 Sep 15, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-001 Oct 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
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 Date
➤ Subscribe Oral Solution 80 mg/20 mg per mL ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 100 mg/25 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for KALETRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00060 Netherlands ➤ Try a Free Trial 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
C/GB01/044 United Kingdom ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Teva
Fish and Richardson
Harvard Business School
Farmers Insurance
QuintilesIMS
Queensland Health
Julphar
UBS

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