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AZACTAM

NDA

AZTREONAM | N050580 | LABORATOIRES DELBERT

3 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Azactam (2023)

Total Spending

$207K

Total Claims

395

Beneficiaries

176

Avg Cost/Unit

$9.61

Spending Trend

$488K(2019)→$309K(2020)→$339K(2021)→$218K(2022)→$207K(2023)

YoY Change:+124.3%

5yr CAGR:+3.8%

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

Medicare Part B Spending

CMS physician-administered drug spending for Azactam (2023)

Total Spending

$14K

Total Claims

Beneficiaries

ASP Price

—

HCPCS: J0457 — Injection, aztreonam, 100 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain10 active DMFs3 inactive

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

CURIA ITALY SRLAZTREONAM HYDRATED NON-STERILE ALPHA-FORM

DMF 171842004

TAPI NL BVAZTREONAM USP

DMF 193422006

CHONGQING SHENGHUAXI PHARMACEUTICAL CO LTDAZTREONAM

DMF 268562013

GUANG'AN KINGDAY PHARMA AND CHEM CO LTDAZTREONAM USP

DMF 275082013

CURIA ITALY SRLAZTREONAM BETA FORM

DMF 337312019

CURIA ITALY SRLAZTREONAM ALFA FORM

DMF 337622019

CURIA FRANCE SASAZTREONAM BETA FORM

DMF 380552023

APITORIA PHARMA PRIVATE LTDAZTREONAM USP

DMF 386492023

CURIA FRANCE SASAZTREONAM ALFA FORM

DMF 397312024

FRESENIUS KABI IPSUM SRLAZTREONAM NON STERILE ALPHA

DMF 408412025

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveAZTREONAM

DMF 167512003

ORCHID CHEMICALS AND PHARMACEUTICALS LTDInactiveAZTREONAM

DMF 200142006

CHONGQING FUAN PHARMACEUTICAL CO LTDInactiveAZTREONAM USP (NON-STERILE BULK DRUG SUBSTANCE)

DMF 239712010

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Apr 19, 2021	SUPPL -46	View Letter (PDF)
Jun 21, 2018	SUPPL -44	View Letter (PDF)
Jun 18, 2013	SUPPL -42	View Letter (PDF)
Jan 24, 2008	SUPPL -40	View Letter (PDF)
Dec 30, 2004	SUPPL -37	View Letter (PDF)
Mar 25, 2002	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 31, 1986

No patent or exclusivity listings for this strength.

#002 — 1GM/VIAL

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 31, 1986

#003 — 2GM/VIAL

RLDAP

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 31, 1986

Change History (6)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Azactam (aztreonam) applicant changed from Bristol Myers Squibb to Labs Delbert.

Old: BRISTOL MYERS SQUIBB

New: LABS DELBERT

MODIFIEDApplicant Full Name7/1/2026

AZACTAM (aztreonam) applicant changed from Bristol Myers Squibb to Laboratoires Delbert for NDA 050580.

Old: BRISTOL MYERS SQUIBB

New: LABORATOIRES DELBERT

MODIFIEDApplicant7/1/2026

AZACTAM (aztreonam) NDA 050580 applicant changed from Bristol Myers Squibb to Labs Delbert.

Old: BRISTOL MYERS SQUIBB

New: LABS DELBERT

MODIFIEDApplicant Full Name7/1/2026

Laboratoires Delbert replaced Bristol Myers Squibb as the listed applicant for Azactam (aztreonam) NDA 050580.

Old: BRISTOL MYERS SQUIBB

New: LABORATOIRES DELBERT

MODIFIEDApplicant7/1/2026

LABS DELBERT replaced Bristol Myers Squibb as the applicant for Azactam (aztreonam) NDA 050580.

Old: BRISTOL MYERS SQUIBB

New: LABS DELBERT

MODIFIEDApplicant Full Name7/1/2026

Laboratoires Delbert replaced Bristol Myers Squibb as the listed applicant for Azactam (aztreonam) NDA 050580.

Old: BRISTOL MYERS SQUIBB

New: LABORATOIRES DELBERT