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CEFTRIAXONE Drug Profile
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When do Ceftriaxone patents expire, and when can generic versions of Ceftriaxone launch?
Ceftriaxone is a drug marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu Pharm Co Ltd, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, Akorn Inc, Astral, Cephazone Pharma, Hikma Farmaceutica, Teva Pharms Usa, B Braun, Baxter Hlthcare, and Hikma. and is included in thirty-six NDAs.
The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
US ANDA Litigation and Generic Entry Outlook for Ceftriaxone
A generic version of CEFTRIAXONE was launched as ceftriaxone sodium by ASTRAL on December 14th, 2019.
Summary for CEFTRIAXONE
| US Patents: | 0 |
| Applicants: | 22 |
| NDAs: | 36 |
| Suppliers / Packagers: | 19 |
| Bulk Api Vendors: | 33 |
| Clinical Trials: | 134 |
| Patent Applications: | 6,337 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CEFTRIAXONE |
| DailyMed Link: | CEFTRIAXONE at DailyMed |
Recent Clinical Trials for CEFTRIAXONE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sunnybrook Research Institute | Phase 4 |
| Dr. Damon Scales | Phase 4 |
| Canadian Institutes of Health Research (CIHR) | Phase 4 |
Pharmacology for CEFTRIAXONE
| Drug Class | Cephalosporin Antibacterial |
Synonyms for CEFTRIAXONE
| (6R,7R,)-7-(2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-((2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-ylthio)methyl)-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
| (6R,7R,Z)-7-(2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-((2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-ylthio)methyl)-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
| (6R,7R,Z)-7-(2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-((6-hydroxy-2-methyl-5-oxo-2,5-dihydro-1,2,4-triazin-3-ylthio)methyl)-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
| (6R,7R)-7-({(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-[(methyloxy)imino]acetyl}amino)-3-{[(6-hydroxy-2-methyl-5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)thio]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
| (6R,7R)-7-[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido]-3-{[(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
| (6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(2-methyl-5,6-dioxo-1H-1,2,4-triazin-3-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
| (6R,7R)-7-[[(2Z)-2-(2-aminothiazol-4-yl)-2-methoxyimino-acetyl]amino]-3-[(2-methyl-5,6-dioxo-1H-1,2,4-triazin-3-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
| (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7^2-(Z)-(O- |
| (6R,7R)-7-{[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-{[(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
| (6R,7R)-7-{2-(2-Amino-thiazol-4-yl)-2-[(Z)-methoxyimino]-acetylamino}-3-(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-[1,2,4]triazin-3-ylsulfanylmethyl)-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
| (6R,7R)-7-{2-(2-Amino-thiazol-4-yl)-2-[(Z)-methoxyimino]-acetylamino}-3-(6-hydroxy-2-methyl-5-oxo-2,5-dihydro-[1,2,4]triazin-3-ylsulfanylmethyl)-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid |
| 104376-79-6 (di-hydrochloride salt) |
| 5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-(((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-8-oxo-3-(((1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio)methyl)-, (6R-(6alpha,7beta(Z)))- |
| 5-Thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-(((2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl)amino)-8-oxo-3-(((1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio)methyl)-, (6R,7R)- |
| 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2Z)-2-(2-amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, (6R,7R)- |
| 7-[2-(2-Amino-thiazol-4-yl)-2-methoxyimino-acetylamino]-3-(6-hydroxy-2-methyl-5-oxo-2,5-dihydro-[1,2,4]triazin-3-ylsulfanylmethyl)-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid (Ceftriaxone) |
| 7-[2-(2-Amino-thiazol-4-yl)-2-methoxyimino-acetylamino]-3-(6-hydroxy-2-methyl-5-oxo-2,5-dihydro-[1,2,4]triazin-3-ylsulfanylmethyl)-8-oxo-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic acid(Ceftriaxone) |
| 73384-59-5 |
| 74578-69-1 |
| 74578-69-1 (di-hydrochloride salt, hemiheptahydrate) |
| 75J73V1629 |
| 7beta-{[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-{[(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl}-3,4-didehydrocepham-4-carboxylic acid |
| AC-1592 |
| AC1NUIFE |
| AKOS015960618 |
| AN-14520 |
| AN-14762 |
| AN-37256 |
| BC203714 |
| BDBM50049707 |
| BDBM50103601 |
| Biotrakson |
| C06683 |
| C18H18N8O7S3 |
| Cefatriaxone |
| Cefatriaxone hydrate |
| Cefatriaxone, Antibiotic for Culture Media Use Only |
| Ceftriaxon |
| Ceftriaxona |
| Ceftriaxona [INN-Spanish] |
| Ceftriaxone (INN) |
| Ceftriaxone (TN) |
| Ceftriaxone [USAN:INN:JAN] |
| Ceftriaxone [USAN:JAN] |
| Ceftriaxone and Dextrose in Duplex Container |
| Ceftriaxone free acid |
| Ceftriaxone intravenous |
| CEFTRIAXONE SODIUM |
| Ceftriaxone sodium hydrate |
| Ceftriaxone, Disodium Salt |
| Ceftriaxone, Disodium Salt, Hemiheptahydrate |
| Ceftriaxonum |
| Ceftriaxonum [INN-Latin] |
| Ceftriazone |
| Cephtriaxone |
| CHEBI:29007 |
| CHEMBL161 |
| CS-2948 |
| CTRX |
| D07659 |
| DB01212 |
| DRG-0071 |
| DTXSID0022773 |
| EINECS 277-405-6 |
| HY-B0712 |
| K250 |
| Longacef |
| LS-150031 |
| Ro 13-9904 |
| Ro 13-9904/001 |
| Ro 139904 |
| Ro-13-9904 |
| Rocefin |
| Rocephalin |
| Rocephin |
| Rocephine |
| Rophex |
| SCHEMBL23354 |
| UNII-75J73V1629 |
| VAAUVRVFOQPIGI-SPQHTLEESA-N |
| W-104454 |
| X 13-9904 |
| ZINC8584434 |
US Patents and Regulatory Information for CEFTRIAXONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Usa | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065227-004 | Mar 15, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Cephazone Pharma | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065294-001 | Mar 26, 2007 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Aurobindo Pharma Ltd | CEFTRIAXONE | ceftriaxone sodium | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 065505-004 | Jul 31, 2008 | 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 |
