Indinavir sulfate - Generic Drug Details

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What are the generic sources for indinavir sulfate and what is the scope of freedom to operate?

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.

Summary for indinavir sulfate

International Patents:	42
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	58
Clinical Trials:	81
Patent Applications:	4,074
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for indinavir sulfate
DailyMed Link:	indinavir sulfate at DailyMed

Recent Clinical Trials for indinavir sulfate

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Sponsor	Phase
Oncology Institute of Southern Switzerland	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A
PPD	Phase 3

See all indinavir sulfate clinical trials

Recent Litigation for indinavir sulfate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

Drug Class	Protease Inhibitor
Mechanism of Action	HIV Protease Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for indinavir sulfate

HIV Protease Inhibitors

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
(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
157810-81-6
771H53976Q
810I816
AB0011299
AC-1935
AK-72910
AKOS015920149
AS-30738
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, 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)
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
Indinivar sulphate
L 735524
L-735,524
LS-102243
MK 639
MK-639
MLS001401425
MLS006010223
NC00232
NCGC00159460-02
NCGC00159460-04
NCGC00255764-01
NSC-697197
NSC697197
Q27106928
S-6056
s9567
SAM001246588
SCHEMBL41040
SMR000469161
ST24030779
Tox21_111687
Tox21_111687_1
Tox21_302415
UNII-771H53976Q

US Patents and Regulatory Information for indinavir sulfate

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Glossary

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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	020685-003	Mar 13, 1996		DISCN	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	020685-001	Mar 13, 1996		RX	Yes	Yes	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	020685-001	Mar 13, 1996	Start Trial	Start Trial
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	020685-003	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	020685-005	Dec 17, 1998	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for indinavir sulfate

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Country	Patent Number	Estimated Expiration
China	1179722	Start Trial
China	1160081	Start Trial
Yugoslavia	49417	Start Trial
Canada	2211973	Start Trial
Yugoslavia	6396	Start Trial
Iceland	4533	Start Trial
>Country	>Patent Number	>Estimated Expiration

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