Viewing data from:

ROCEPHIN

NDA

CEFTRIAXONE SODIUM | N050585 | HOFFMANN LA ROCHE INC

7 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Leydig, Voit & Mayer, Ltd. - Citizen Petition FDA-2009-P-0177 · 5 docket documents Leydig, Voit & Mayer, Ltd. filed this citizen petition under 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that New Drug Application No. 050585 for ROCEPHIN® Injection (Ceftriaxone Sodium Injection) in strengths of 250 mg, 500 mg, 1 g, 2 g, and 10 g base p	505(q)	2009-04-07	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

114 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 79 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia NCT03413384	Phase 2	Active	BrainX Corporation	100	2019-02-15 → 2025-12-31
Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery NCT02996656	N/A	Recruiting	Université de Montréal	88	2016-12 → 2026-12
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
Prophylactic Antibiotics in Admitted Cirrhotics NCT04218695	Phase 4	Completed	Beth Israel Deaconess Medical Center	32	2020-08-24 → 2021-08-28
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection NCT01473836	Phase 3	Completed	Pfizer	38	2011-11 → 2012-10
RCT to Determine the Efficacy of Combining Hemospray With Medical Treatment in Acute Variceal Bleeding NCT03061604	N/A	Completed	Theodor Bilharz Research Institute	105	2014-11 → 2017-11
The Importance of Anti-anaerobic Therapy for Acute Pelvic Inflammatory Disease (PID)NCT01160640	Phase 2	Completed	Harold Wiesenfeld	233	2010-11 → 2015-08
Brain Imaging and Retreatment Study of Persistent Lyme Disease NCT00037479	Phase 2	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	65	1999-12
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea NCT04010539	Phase 3	Completed	GlaxoSmithKline	628	2019-10-21 → 2023-10-10
Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia NCT00621504	Phase 3	Completed	Forest Laboratories	606	2008-01 → 2009-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain10 active DMFs14 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

SANDOZ GMBHCEFTRIAXONE SODIUM (STERILE)

DMF 164672003

ORCHID PHARMA LTDCEFTRIAXONE SODIUM

DMF 172572004

ACS DOBFAR SPACEFTRIAXONE SODIUM, USP (STERILE BULK)

DMF 172592004

ACS DOBFAR SPACEFTRIAXONE SODIUM NON STERILE USP

DMF 175412004

FRESENIUS KABI IPSUM SRLCEFTRIAXONE SODIUM STERILE

DMF 196272006

NECTAR LIFESCIENCES LTDCEFTRIAXONE SODIUM (NON-STERILE) DRUG SUBSTANCE

DMF 241342010

NECTAR LIFESCIENCES LTDCEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE

DMF 243542010

NECTAR LIFESCIENCES LTDCEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE (PROCESS-II)

DMF 255612012

STERILE INDIA PVT LTDCEFTRIAXONE SODIUM USP (STERILE)

DMF 299822016

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTDCEFTRIAXONE SODIUM (NON-STERILE BULK) USP

DMF 335012019

ROCHE PHARMACEUTICALS DIV HOFFMANN LAROCHE INCInactiveCEFTRIAXONE SODIUM

DMF 136561998

LUPIN LTDInactiveCEFTRIAXONE SODIUM USP (STERILE )

DMF 159312002

ORCHID CHEMICALS AND PHARMACEUTICALS LTDInactiveCEFTRIAXONE SODIUM

DMF 177142004

AUROBINDO PHARMA LTDInactiveCEFTRIAXONE SODIUM

DMF 178242004

HAMNMI FINE CHEMICAL CO LTDInactiveCEFTRIAXONE SODIUM, USP

DMF 178842004

AUROBINDO PHARMA LTDInactiveCEFTRIAXONE SODIUM (STERILE)

DMF 179112004

ANTIBIOTICOS DO BRASIL LTDAInactiveCEFTRIAXONE SODIUM USP (STERILE BULK)

DMF 193372006

KYONGBO PHARMACEUTICAL CO LTDInactiveCEFTRIAXONE SODIUM STERILE

DMF 200772006

ACS DOBFAR SPAInactiveCEFTRIAXONE SODIUM USP STERILE 100 GRAMS

DMF 206362007

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveCEFTRIAXONE SODIUM (NON-STERILE)

DMF 241602010

SANDOZ INDUSTRIAL PRODUCTS GMBHInactiveCEFTRIAXONE SODIUM STERILE

DMF 244122010

CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTDInactiveCEFTRIAXONE SODIUM STERILE

DMF 253812011

ZHUHAI UNITED LABORATORIES CO LTDInactiveCEFTRIAXONE SODIUM USP

DMF 259462012

SINOPHARM WEIQIDA PHARMACEUTICAL CO LTDInactiveCEFTRIAXONE SODIUM, USP

DMF 330152018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jul 16, 2018	SUPPL -68	View Letter (PDF)
Jul 8, 2015	SUPPL -67	View Letter (PDF)
Mar 24, 2015	SUPPL -66	View Letter (PDF)
Apr 16, 2013	SUPPL -65	View Letter (PDF)
Nov 18, 2010	SUPPL -62	View Letter (PDF)
Mar 4, 2010	SUPPL -64	View Letter (PDF)
Jun 16, 2009	SUPPL -63	View Letter (PDF)
Mar 13, 2009	SUPPL -61	View Letter (PDF)
Aug 20, 2008	SUPPL -60	View Letter (PDF)
Jul 24, 2007	SUPPL -58	View Letter (PDF)
May 16, 2007	SUPPL -59	View Letter (PDF)
Sep 15, 2004	SUPPL -57	View Letter (PDF)
Sep 3, 2004	SUPPL -56	View Letter (PDF)
Apr 7, 2004	SUPPL -54	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (7)

Sort:

#001 — EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Approved: Dec 21, 1984

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Approved: Dec 21, 1984

#003 — EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Approved: Dec 21, 1984

#004 — EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Approved: Dec 21, 1984

#005 — EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 21, 1984

#006 — EQ 1GM BASE/VIAL,N/A;N/A,1%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 8, 1996

#007 — EQ 500MG BASE/VIAL,N/A;N/A,1%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 8, 1996