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Indinavir sulfate - Generic Drug Details
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.
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: | 56 |
| Clinical Trials: | 81 |
| Patent Applications: | 4,033 |
| 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
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Oncology Institute of Southern Switzerland | Phase 2 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | N/A |
| Agouron Pharmaceuticals | N/A |
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 |
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
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 | 020685-003 | Mar 13, 1996 | RX | Yes | 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
| 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 | 020685-003 | Mar 13, 1996 | Start Trial | Start Trial |
| Merck Sharp Dohme | CRIXIVAN | indinavir sulfate | CAPSULE;ORAL | 020685-005 | Dec 17, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for indinavir sulfate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 116925 | Start Trial |
| Yugoslavia | 6396 | Start Trial |
| China | 1160081 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.
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