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Generated: March 21, 2019

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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. 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
(1S-(1R*(R*),3R*,4R*))-N-(4-(((2,6-Dimethylphenoxy)acetyl)amino)-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl)tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide
(2S)-N-((1S,3S,4S)-1-benzyl-4-{[(2,6-dimethylphenoxy)acetyl]amino}-3-hydroxy-5-phenylpentyl)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide
(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
(2S)-N-[(1S,3S,4S)-1-benzyl-4-{[(2,6-dimethylphenoxy)acetyl]amino}-3-hydroxy-5-phenylpentyl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide
(2S)-N-[(2S,4S,5S)-5-[[2-(2,6-dimethylphenoxy)acetyl]amino]-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxo-1,3-diazinan-1-yl)butanamide
(2S)-N-[(2S,4S,5S)-5-[2-(2,6-dimethylphenoxy)acetamido]-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxo-1,3-diazinan-1-yl)butanamide
(2S)-N-[(2S,4S,5S)-5-{[(2,6-dimethylphenoxy)acetyl]amino}-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide
(alphaS)-N-[(1S,3S,4S)-4-[[2-(2,6-Dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pyrimidineacetamide
(alphaS)-Tetrahydro-N-((alphaS)-alpha-((2S,3S)-2-hydroxy-4-phenyl-3-(2-(2,6-xylyloxy)acetamido)butyl)phenethyl)-alpha-isopropyl-2-oxo-1(2H)-pyrimidineacetamide
(S)-N-((2S,4S,5S)-5-(2-(2,6-dimethylphenoxy)acetamido)-4-hydroxy-1,6-diphenylhexan-2-yl)-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide
1(2H)-Pyrimidineacetamide, N-((1S,3S,4S)-4-(((2,6-dimethylphenoxy)acetyl)amino)-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl)tetrahyrdo-alpha-1-methylethyl)-2-oxo-, (alphaS)-
1(2H)-Pyrimidineacetamide, N-[(1S,3S,4S)-4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-.alpha.-(1-methylethyl)-2-oxo-, (aS)-
1(2H)-Pyrimidineacetamide, N-[(1S,3S,4S)-4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-, (alphaS)- (9CI)
1(2H)-pyrimidineacetamide, N-[(1S,3S,4S)-4-[[2-(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-, (alphaS)-
1(2H)-Pyrimidineacetamide, N-[4-[[(2,6-dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-, [1S-[1R*(R*),3R*,4R*]]-
1(2H)-pyrimidineacetamide,N-((1S,3S,4S)-4-(((2,6-dimethylphenoxy)acetyl)amino)-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl)tetrahydro-alpha-1-methylethyl)-2-oxo-,(alphaS)-
111995-EP2272516A2
111995-EP2298761A1
111995-EP2298783A1
192725-17-0
1mui
24233-EP2298761A1
24233-EP2298783A1
24233-EP2314590A1
2494G1JF75
2o4s
2q5k
2qhc
2rkf
2rkg
3ogq
4l1a
A 157378
A 157378.0
A-157378-0
A-157378.0
AB0071033
AB01274785_02
AB01274785-01
AB1
ABT 157378
ABT 378
ABT-378
ABT-378, LOPINAVIR
AC1L3OPJ
AIDS032937
AKOS025243115
Aluviran
AN-6726
AOB1042
BCP9000857
BCPP000184
BDBM50180655
BRD-K99451608-001-02-4
C12871
CAS-192725-17-0
CHEBI:31781
CHEMBL729
CS-2077
CTK8E9936
D01425
DB01601
DSSTox_CID_26456
DSSTox_GSID_46456
DSSTox_RID_81630
DTXSID8046456
HSDB 8138
HY-14588
J-521653
KJHKTHWMRKYKJE-SUGCFTRWSA-N
koletr
Koletra
KS-000000TF
KS-1436
Lopinavir
Lopinavir (ABT-378)
Lopinavir (JAN/USAN/INN)
Lopinavir [USAN:INN:BAN]
Lopinavir [USAN:USP:INN:BAN]
Lopinavir & alpha1-acid glycoprotein
Lopinavir & PLGA
Lopinavir & Poly-lactide-co-glycolide
Lopinavir, ABT 378
LPV
LPV & AAG
LS-173766
MLS003915624
MLS004774152
MLS006011206
MolPort-003-848-410
N-(4-(((2,6-dimethylphenoxy)acetyl)amino)-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl)tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2H)-pydrimidineacetamide
N-{1-BENZYL-4-[2-(2,6-DIMETHYL-PHENOXY)-ACETYLAMINO]-3-HYDROXY-5-PHENYL-PENTYL}-3-METHYL-2-(2-OXO-TETRAHYDRO-PYRIMIDIN-1-YL)-BUTYRAMIDE
NCGC00164576-01
NCGC00164576-02
NCGC00164576-03
NCGC00164576-04
RS-346
RTR-008945
s1380
SCHEMBL21775
SMR002529581
SR-01000931910
SR-01000931910-2
SW219767-1
Tox21_112204
Tox21_112204_1
TR-008945
UNII-2494G1JF75
ZINC3951740

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
Abbvie KALETRA lopinavir; ritonavir CAPSULE;ORAL 021226-001 Sep 15, 2000 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie KALETRA lopinavir; ritonavir TABLET;ORAL 021906-002 Nov 9, 2007 RX Yes No ➤ 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
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 TABLET;ORAL 021906-001 Oct 28, 2005 ➤ 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 021906-001 Oct 28, 2005 ➤ 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 Date
➤ Subscribe Oral Solution 80 mg/20 mg per mL ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 100 mg/25 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for KALETRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0674513 C300060 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
0674513 SPC/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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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