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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
QuintilesIMS
Cerilliant
Colorcon
Teva
Chinese Patent Office
AstraZeneca
McKesson
Chubb

Generated: June 19, 2018

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NORVIR Drug Profile

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When do Norvir patents expire, and what generic alternatives are available?

Norvir is a drug marketed by Abbott, Abbvie, and Abbvie Inc. and is included in five NDAs. There are nine 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 NORVIR is ritonavir. There are twenty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ritonavir profile page.
Drug patent expirations by year for NORVIR
Medical Subject Heading (MeSH) Categories for NORVIR
Synonyms for NORVIR
(2S, 3S, 5S)-5-(N-(N-((N-Methyl-N-((2-isopropyl-4-thiazolyl)methyl)amino)carbonyl)valinvl)amino)-2-(N-((5-thiazolyl)methoxycarbonyl)amino)-1,6-diphenyl-3-hydroxyhexane
(2S,3S,5S )-5-(N-(N-((N-Methyl-N-((2-isopropyl-4-thiazolyl) methyl)amino)carbonyl)valinyl)amino)-2-(N-((5-thiazolyl) methoxycarbonyl)amino)-1,6-diphenyl-3-hydroxyhexane
(2S,3S,5S)-5-(N-(N-((N-MethyI-N-((2-isopropyl-4-thiazolyl)methyl)amino)carbonyl)valinyl)amino)-2-(N-((5-thiazolyl)methoxycarbonyl)amino)-1.6-diphenyl-3-hydroxyhexane
(2S,3S,5S)-5-(N-(N-((N-Methyl-N-((2-isopropyl-4-thiazolyl) methyl)amino)carbonyl)valinyl)amino)-2-(N-((5-thiazolyl)methoxycarbonyl)amino)-1,6-diphenyl-3-hydroxyhexane
(2S,3S,5S)-5-(N-(N-((N-Methyl-N-((2-isopropyl-4-thiazolyl)methyl)amino)carbonyl)valinyl)amino )-2-(N-((5-thiazolyl)methoxycarbonyl)amino)-1,6-diphenyl-3-hydroxyhexane
(2S,3S,5S)-5-(N-(N-((N-Methyl-N-((2-isopropyl-4-thiazolyl)methyl)amino)carbonyl)valinyl)amino)-2-(N-((5-thiazolyl)methoxycarbonyl)amino)-1 .6-diphenyl-3-hydroxyhexane
(2S,3S,5S)-5-(N-(N-((N-Methyl-N-((2-isopropyl-4-thiazolyl)methyl)amino)carbonyl)valinyl)amino)-2-(N-((5-thiazolyl)methoxycarbonyl)amino)-1,6-diphenyl-3-hydroxyhexane
(2S,3S,5S)-5-(N-(N-((N-Methyl-N-((2-isopropyl-4-thiazolyl)methyl)amino)carbonyl)valinyl)amino)-2-(N-((5-thiazolyl)methoxycarbonyl)amino)-1,6-diphenyl-3hydroxyhexane
(2S,3S,5S)-5-(N-(N-((N-Methyl-N-((2-isopropyl-4-thiazolyl)methyl)amino)carbonyl)valinyl)amino)-2-(N-((5-thiazolyl)methoxycarbonyl)amino)-1.6-diphenyl-3-hydroxyhexane
(2S,3S,5S)-5-(N-(N((N-Methyl-N-((2-isopropyl-4-thiazolyl)methyl)amino)carbonyl)valinyl)amino)-2-(N-((5-thiazolyl)methoxycarbonyl)amino)-1,6-diphenyl-3-hydroxyhexane
1,3-Thiazol-5-ylmethyl N-[(2s,3s,5r)-3-hydroxy-5-[[(2s)-3-methyl-2-[[methyl-[(2-propan-2-yl-1,3-thiazol-4-yl)methyl]carbamoyl]amino]butanoyl]amino]-1,6-dipheny
1,3-Thiazol-5-ylmethyl N-[(2S,3S,5R)-3-hydroxy-5-[[(2S)-3-methyl-2-[[methyl-[(2-propan-2-yl-1,3-thiazol-4-yl)methyl]carbamoyl]amino]butanoyl]amino]-1,6-diphenyl-hexan-2-yl]carbamate
1,3-thiazol-5-ylmethyl N-[(2S,3S,5S)-3-hydroxy-5-[[(2S)-3-methyl-2-[[methyl-[(2-propan-2-yl-1,3-thiazol-4-yl)methyl]carbamoyl]amino]butanoyl]amino]-1,6-di(phenyl)hexan-2-yl]carbamate
1,3-thiazol-5-ylmethyl N-[(2S,3S,5S)-3-hydroxy-5-[[(2S)-3-methyl-2-[[methyl-[(2-propan-2-yl-1,3-thiazol-4-yl)methyl]carbamoyl]amino]butanoyl]amino]-1,6-diphenylhexan-2-yl]carbamate
111505-EP2298751A2
114619-EP2269994A1
114619-EP2287155A1
114619-EP2292234A1
114619-EP2292613A1
114619-EP2298783A1
155213-67-5
1hxw
1sh9
2,4,7,12-Tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-(2-(1-methylethyl)-4-thiazolyl)-3,6-dioxo-8,11-bis(phenylmethyl)-, 5-thiazolylmethyl ester, (5S-(5R*,8R*,10R*,11R*))-
2,4,7,12-Tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-(2-(1-methylethyl)-4-thiazolyl)-3,6-dioxo-8,11-bis(phenylmethyl)-, 5-thiazolylmethyl ester,(5S,8S,10S,11S)-
2,4,7,12-Tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-, 5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]-
200988-EP2272825A2
213R675
3prs
3tne
4eyr
5-Thiazolylmethyl ((alphaS)-alpha-((1S,3S-1-hydroxy-3-((2S)-2-(3-((2-isopropyl-4-thiazolyl)methyl)-3-methylureido)-3-methylbutyramido)-4-phenylbutyl)phenethyl)carbamate
5-Thiazolylmethyl ((alphaS)-alpha-((1S,3S)-1-hydroxy-3-((2S)-2-(3-((2-isopropyl-4-thiazolyl)methyl)-3-methylureido)-3-methylbutyramido)-4-phenylbutyl)phenethyl)carbamate
5-Thiazolylmethyl (3S,4S,6S,9S)-4-hydroxy-12-methyl-9-(1-methylethyl)-13-[2-(1-methylethyl)-4-thiazolyl]-8,11-dioxo-3,6-bis(phenylmethyl)-2,7,10,12-tetraazatridecanoate
538, ABT
A-84538
AB00639991_09
AB00639991_10
AB00639991-06
AB00639991-08
AB0071565
Abbot 84538
Abbott 84538
ABBOTT-84538
ABT 538
ABT 84538
ABT-538
ABT538
AC-733
AC1L94GB
AK322135
AKOS000280930
AM017217
AN-6678
AOB1044
BC204109
BDBM50088504
BIDD:GT0387
BIDD:PXR0023
Bio-0093
BRD-K51485625-001-07-6
C07240
C37H48N6O5S2
CAS-155213-67-5
CCG-101007
CHEBI:45409
CHEMBL163
chembrdg-bb 4050354
CPD000466395
CS-0432
D00427
D0ZU9R
DB00503
DR003510
DRG-0244
DSSTox_CID_28553
DSSTox_GSID_48627
DSSTox_RID_82825
DTXSID1048627
EBD15480
FT-0082824
FT-0601625
GTPL8804
HMS2051B08
HMS2235O10
HSDB 7160
HY-90001
J-009178
KS-000002DW
KS-5017
liponavir core
LS-148860
MCULE-9029064305
MFCD00927142
MLS000759541
MLS000759541-02
MLS001424063
MLS006011764
MolPort-000-883-877
MRF-0000287
N-[(2S,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl]-N(2)-(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)-L-valinamide
N-[(2S,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl]-N~2~-(methyl{[2-(propan-2-yl)-1,3-thiazol-4-yl]methyl}carbamoyl)-L-valinamide
N1-((1S,3S,4S)-1-benzyl-3-hydroxy-5-phenyl-4-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}pentyl)-N2-{[[(2-isopropyl-1,3-thiazol-4-yl)methyl](methyl)amino]carbonyl}-L-valinamide
NC00257
NCDNCNXCDXHOMX-XGKFQTDJSA-N
NCGC00159462-02
NCGC00159462-03
NCGC00159462-04
NCGC00183130-01
Norvir (TM)
Norvir (TN)
Norvir Sec
Norvir Softgel
NSC-693184
NSC-760369
NSC693184
NSC760369
O3J8G9O825
Pharmakon1600-01502391
PubChem20003
R0116
rarechem al bd 1261
RIT
ritonavir
Ritonavir (JAN/USAN/INN)
Ritonavir [USAN:USP:INN:BAN]
Ritonavir [USAN]
Ritonavir & PLGA
Ritonavir & Poly-lactide-co-glycolide
Ritonavir solution, 1.0 mg/mL in acetonitrile, certified reference material
Ritonavir, >=98% (HPLC)
Ritonavire
Ritonavirum
RL01991
RTV
s1185
SAM001246783
SC-17022
SCHEMBL6679
SMR000466395
STK634209
thiazol-5-ylmethyl ((2S,3S,5S)-3-hydroxy-5-((S)-2-(3-((2-isopropylthiazol-4-yl)methyl)-3-methylureido)-3-methylbutanamido)-1,6-diphenylhexan-2-yl)carbamate
thiazol-5-ylmethyl N-[(1S,2S,4S)-1-benzyl-2-hydroxy-4-[[(2S)-2-[[(2-isopropylthiazol-4-yl)methyl-methyl-carbamoyl]amino]-3-methyl-butanoyl]amino]-5-phenyl-pentyl]carbamate
TMC 114r
Tox21_112969
Tox21_112969_1
Tox21_113431
UNII-O3J8G9O825
W-5223
ZINC3944422

US Patents and Regulatory Information for NORVIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott NORVIR ritonavir CAPSULE;ORAL 020680-001 Mar 1, 1996 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie NORVIR ritonavir CAPSULE;ORAL 020945-001 Jun 29, 1999 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010 AB 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 NORVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbott NORVIR ritonavir CAPSULE;ORAL 020680-001 Mar 1, 1996 ➤ Sign Up ➤ Sign Up
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010 ➤ Sign Up ➤ Sign Up
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010 ➤ Sign Up ➤ Sign Up
Abbvie NORVIR ritonavir TABLET;ORAL 022417-001 Feb 10, 2010 ➤ 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 NORVIR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 100 mg ➤ Subscribe 2012-10-31
➤ Subscribe Tablets 100 mg ➤ Subscribe 2010-12-21

Non-Orange Book US Patents for NORVIR

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
6,894,171 Polymorph of a pharmaceutical ➤ Sign Up
7,659,405 Polymorph of a pharmaceutical ➤ Sign Up
8,193,367 Polymorph of a pharmaceutical ➤ Sign Up
6,458,818 Pharmaceutical composition ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NORVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0674513 Switzerland ➤ Sign Up PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Citi
Healthtrust
Moodys
Dow
AstraZeneca
Merck
McKinsey
McKesson

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