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Last Updated: December 5, 2019

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Indinavir sulfate - Generic Drug Details

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What are the generic sources for indinavir sulfate and what is the scope of patent protection?

Indinavir sulfate is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Indinavir sulfate has forty-two patent family members in thirty-five countries.

There are two drug master file entries for indinavir sulfate. One supplier is listed for this compound.

Recent Clinical Trials for indinavir sulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Oncology Institute of Southern SwitzerlandPhase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)N/A
Agouron PharmaceuticalsN/A

See all indinavir sulfate clinical trials

Recent Litigation for indinavir sulfate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Gilead Sciences, Inc. v. Merck & Co., Inc.2016-07-06
Monsanto Company v. Syngenta Seeds Inc.2004-05-12

See all indinavir sulfate litigation

Pharmacology for indinavir sulfate
Medical Subject Heading (MeSH) Categories for indinavir sulfate
Synonyms for indinavir sulfate
(2S)-1-[(2S,4R)-4-benzyl-2-hydroxy-4-{[(1S,2R)-2-hydroxy-2,3-dihydro-1H-inden-1-yl]carbamoyl}butyl]-N-tert-butyl-4-(pyridin-3-ylmethyl)piperazine-2-carboxamide; sulfuric acid
(2S)-1-[(2S,4R)-4-benzyl-2-hydroxy-5-[[(1S,2R)-2-hydroxy-2,3-dihydro-1H-inden-1-yl]amino]-5-oxopentyl]-N-tert-butyl-4-(pyridin-3-ylmethyl)piperazine-2-carboxamide; sulfuric acid
(2S)-1-[(2S,4R)-4-benzyl-2-hydroxy-5-[[(1S,2R)-2-hydroxy-2,3-dihydro-1H-inden-1-yl]amino]-5-oxopentyl]-N-tert-butyl-4-(pyridin-3-ylmethyl)piperazine-2-carboxamide;sulfuric acid
(2S)-1-[(2S,4R)-4-benzyl-2-hydroxy-5-[[(1S,2R)-2-hydroxyindan-1-yl]amino]-5-oxo-pentyl]-N-tert-butyl-4-(3-pyridylmethyl)piperazine-2-carboxamide; sulfuric acid
(alphaR,gammaS,2S)-alpha-Benzyl-2-(tert-butylcarbamoyl)-gamma-hydroxy-N-((1S,2R)-2-hydroxy-1-indanyl)-4-(3-pyridylmethyl)-1-piperazinevaleramide sulfate (1:1) (salt)
(S)-1-((2S,4R)-4-benzyl-2-hydroxy-5-(((1S,2R)-2-hydroxy-2,3-dihydro-1H-inden-1-yl)amino)-5-oxopentyl)-N-(tert-butyl)-4-(pyridin-3-ylmethyl)piperazine-2-carboxamide sulfate
[1(1 S ,2 R ),5( S )]-2,3,5-trideoxy- N -(2,3-dihydro-2-hydroxy-1 H -inden-1-yl)-5-[2-[ [(1,1-dimethylethyl)amino]carbonyl]-4-(3-pyridinyl-methyl)-1-piperazinyl] -2 -(phenylmethyl)-D- erythro -pentonamide sulfate (1:1) salt
[1(1 S ,2 R ),5( S )]-2,3,5-trideoxy- N -(2,3-dihydro-2-hydroxy-1 H -inden-1-yl)-5-[2-[[(1,1-dimethylethyl)amino]carbonyl]-4-(3-pyridinyl-methyl)-1-piperazinyl]-2 -(phenylmethyl)-D- erythro -pentonamide sulfate (1:1) salt
[1(1S,2R),5(S)]-2,3,5-trideoxy-N-(2,3-dihydro-2-hydroxy-1H-inden-1-yl)-5-[2-[[(1,1-dimethylethyl)amino]carbonyl]-4-(3-pyridinylmethyl)-1- piperazinyl]-2-(phenylmethyl)-D-erythro-pentonamide sulfate (1:1) salt
150378-17-9 (Parent)
157810-81-6
771H53976Q
810I816
AB0011299
AC-1935
AC1NUWCV
AK-72910
AKOS015920149
AS-30738
BC216007
BR-72910
C08089
C36H47N5O4.H2O4S
C36H47N5O4.H2SO4
CAS-157810-81-6
CCG-100982
CHEBI:5899
CHEMBL1735
CPD000469161
Crixivan
Crixivan (TN)
CS-2931
D-erythro-Pentonamide, 2,3,5-trideoxy-N-((1S,2R)-2,3-dihydro-2-hydroxy-1H-inden-1-yl)-5-((2S)-2-(((1,1-dimethylethyl)amino)carbonyl)-4-(3-pyridinylmethyl)-1-piperazinyl)-2-(phenylmethyl)-, sulfate (1:1) (salt)
D-erythro-Pentonamide, 2,3,5-trideoxy-N-(2,3-dihydro-2-hydroxy-1H-inden-1-yl)-5-(2-(((1,1-dimethylethyl)amino)carbonyl)-4-(3-pyridinylmethyl)-1-piperazinyl)-2-(phenylmethyl)-, (1(1S,2R,5(S))-, sulfate (1:1) (salt)
D-erythro-Pentonamide, 2,3,5-trideoxy-N-(2,3-dihydro-2-hydroxy-1H-inden-1-yl)-5-(2-(((1,1-dimethylethyl)amino)carbonyl)-4-(3-pyridinylmethyl)-1-piperazinyl)-2-(phenylmethyl)-, monohydrate, (1(1S,2R),5(S))-, sulfate (1:1)
D-erythro-Pentonamide,3,5-trideoxy-N-(2,3-dihydro-2- hydroxy-1H-inden-1-yl)-5-[2-[[(1,1-dimethylethyl)amino] carbonyl]-4-(3-pyridinylmethyl)-1-piperazinyl]-2-(phenylmethyl)-, [1(1S,2R),5(S)-, sulfate (1:1) (salt)
D00897
DRG-0233
DSSTox_CID_24221
DSSTox_GSID_44221
DSSTox_RID_80126
DTXSID1044221
FT-0631184
HMS2051P19
HMS2231G18
HMS3715L06
HSDB 7158
HY-B0689A
IDV
Indinavir (sulfate)
Indinavir sulfate (USAN)
Indinavir sulfate [USAN:USP]
Indinavir Sulfate [USAN]
INDINAVIR SULPHATE
indinavir; sulfuric acid
indinavirsulfate(subjecttopatentfree)
Indinivar sulphate
KB-276687
L 735524
L-735,524
L-735524
LS-102243
MK 639
MK-639
mk-639,crixivan
MLS001401425
MLS006010223
MolPort-005-938-421
NC00232
NCGC00159460-02
NCGC00159460-04
NCGC00255764-01
NSC-697197
NSC697197
S-6056
SAM001246588
SCHEMBL41040
SMR000469161
ST24030779
Tox21_111687
Tox21_111687_1
Tox21_302415
UNII-771H53976Q

US Patents and Regulatory Information for indinavir sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-001 Mar 13, 1996 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-003 Mar 13, 1996 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-005 Dec 17, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-006 Apr 19, 2000 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for indinavir sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-006 Apr 19, 2000   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-005 Dec 17, 1998   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-001 Mar 13, 1996   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-003 Mar 13, 1996   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-005 Dec 17, 1998   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-001 Mar 13, 1996   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-003 Mar 13, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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