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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Prevention of Infection of the Respiratory Tract Through Application of Non-Invasive Methods of Secretion Suctioning NCT06113939	Phase 4	Not Yet Recruiting	Hospital San Carlos, Madrid	60	2026-09-15 → 2029-06-30

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

Medicare Part D Spending

CMS annual spending data for Ceftriaxone* (2023)

Total Spending

$24.5M

Total Claims

325,642

Beneficiaries

148,645

Avg Cost/Unit

$4.77

Spending Trend

$18.9M(2019)→$25.0M(2020)→$20.4M(2021)→$21.3M(2022)→$24.5M(2023)

YoY Change:+12.7%

5yr CAGR:+4.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs12 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 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

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

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