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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 indinavir sulfate 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 are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for indinavir sulfate. Three suppliers are listed for this compound.

Summary for indinavir sulfate

US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	50
Clinical Trials:	81
Patent Applications:	3,748
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for indinavir sulfate
DailyMed Link:	indinavir sulfate at DailyMed

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

(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

Ambap157810-81-6

BC216007

BR-72910

C08089

C36H47N5O4.H2O4S

C36H47N5O4.H2SO4

CAS-157810-81-6

CCG-100982

CHEBI:5899

CHEMBL1735

CPD000469161

Crixivan

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

HSDB 7158

HY-B0689A

IDV

Indinavir (sulfate)

Indinavir sulfate (USAN)

Indinavir sulfate [USAN:USP]

Indinavir Sulfate [USAN]

INDINAVIR SULPHATE

indinavir; sulfuric acid

indinavirsulfate(subjecttopatentfree)

indinavirsulphate

Indinivar sulphate

KB-276687

L 735524

L-735,524

L-735524

LS-102243

MFCD00920346

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	020685-005	Dec 17, 1998		DISCN	No	No			Y
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-006	Apr 19, 2000		DISCN	No	No
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-001	Mar 13, 1996		RX	Yes	Yes
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-003	Mar 13, 1996		RX	Yes	No
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-001	Mar 13, 1996		RX	Yes	Yes			Y

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
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-003	Mar 13, 1996
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-001	Mar 13, 1996
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-005	Dec 17, 1998
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-005	Dec 17, 1998

International Patents for indinavir sulfate

Country	Document Number	Estimated Expiration
Canada	2211973
Mexico	9705916
Yugoslavia	6396
Norway	314568
Croatia	P960045