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CAYSTON

NDA

AZTREONAM | N050814 | GILEAD SCIENCES INC

1 strength0 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

31 trials from ClinicalTrials.gov, 20 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection NCT00499720	—	APPROVED_FOR_MARKETING	Gilead Sciences	—	—
Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis NCT00989807	—	APPROVED_FOR_MARKETING	Gilead Sciences	—	—
Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741 NCT03376529	Phase 1	Completed	Spero Therapeutics	27	2017-11-10 → 2017-12-20
Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections NCT00633152	Phase 2	Completed	Forest Laboratories	150	2008-02 → 2008-07
Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa NCT00757237	Phase 3	Completed	Gilead Sciences	274	2008-08 → 2010-11
Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections NCT01811732	Phase 3	Completed	Melinta Therapeutics, Inc.	660	2013-04 → 2014-07
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)NCT01689207	Phase 1	Completed	Pfizer	222	2012-09 → 2014-12
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections NCT00423657	Phase 3	Completed	Forest Laboratories	680	2007-03 → 2007-12
Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis NCT02894684	Phase 4	Completed	Liverpool Heart and Chest Hospital NHS Foundation Trust	16	2017-01 → 2019-09
Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections NCT01984684	Phase 3	Completed	Melinta Therapeutics, Inc.	850	2014-05 → 2016-01

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$7827.34

Highest Price

$7827.34

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61958-0901-01CAYSTON 75MG/VIAL INHALATION SOL	$7827.34	FSS	Gilead Sciences, Inc.	09/29/2026
61958-0901-01CAYSTON 75MG/VIAL INHALATION SOL	$7827.34	Big4	Gilead Sciences, Inc.	09/29/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Cayston (2024)

Total Spending

$34.4M

Total Claims

2,903

Beneficiaries

770

Avg Cost/Unit

$141.21

Spending Trend

$33.0M(2019)→$35.2M(2020)→$32.4M(2021)→$31.8M(2022)→$34.2M(2023)→$34.4M(2024)

YoY Change:-4.3%

5yr CAGR:+4.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs4 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

CHANGZHOU FANGYUAN PHARMACEUTICAL CO LTDInactiveAZTREONAM, NON-STERILE BULK DRUG SUBSTANCE

DMF 209072007

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
Nov 21, 2019	SUPPL -23	View Letter (PDF)
Feb 14, 2019	SUPPL -21	View Letter (PDF)
Dec 30, 2015	SUPPL -16	View Letter (PDF)
Sep 26, 2012	SUPPL -7	View Letter (PDF)
Aug 25, 2010	SUPPL -1	View Letter (PDF)
Feb 26, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 75MG/VIAL

RLD

0 patents0 exclusivities▴

FOR SOLUTION;INHALATION | Approved: Feb 22, 2010

No patent or exclusivity listings for this strength.