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DIAMOX

NDA

ACETAZOLAMIDE SODIUM | N009388 | TEVA WOMENS HEALTH 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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Emcure Pharmaceuticals USA Inc. FDA-2014-P-0979 · 5 docket documents Emcure Pharmaceuticals USA Inc. filed this citizen petition under 21 U.S.C. § 355(j)(2)(c) requesting that the FDA find that Duramed Pharmaceuticals/Barr (Teva) discontinued marketing of DIAMOX (Acetazolamide Injection 500mg base/vial), approved under NDA 009-388, for reasons unrelated to safety and	505(q)	2014-07-17	Granted	Emcure Pharmaceuticals USA Inc.
Lannett Company, Inc. - Citizen Petition FDA-2013-P-1296 · 3 docket documents Lannett Company, Inc. submitted this suitability petition under sections 505(j) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA Commissioner determine that an Abbreviated New Drug Application may be filed for Acetazolamide Extended-Release Tablets using DIAMOX S	Other	2013-11-13	Open	—

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

Clinical Trials

97 trials from ClinicalTrials.gov — 3 recruiting, 2 active, 59 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma NCT03011671	Phase 1	Active	University of Chicago	10	2018-10-03 → 2027-03
Treatment of Orthostatic Intolerance NCT00262470	Phase 1/2	Active	Satish R. Raj	150	1997-04 → 2029-12
Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment NCT04118387	Phase 4	Recruiting	VA Office of Research and Development	200	2021-01-07 → 2026-12-31
Phase I Trial of CArbonic Anhydrase Inhibition in Combination With Radiochemotherapy or Radioimmunotherapy in Small Cell Lung Carcinoma NCT03467360	Phase 1	Recruiting	Centre Antoine Lacassagne	27	2019-08-02 → 2027-04-27
Sleep Apnea in Elderly NCT02703220	Phase 4	Recruiting	VA Office of Research and Development	100	2015-07-03 → 2026-07-31
A Trial of Acetazolamide Versus Placebo in Preventing Mountain Sickness During Rapid Ascent NCT01418157	Phase 4	Completed	Oxford University Clinical Research Unit, Vietnam	380	2011-08 → 2011-10
Intracranial Pressure in Experimental Models of Headache NCT01288781	N/A	Completed	Bangor University	23	2011-07 → 2011-08
Effect of Acetazolamide on Postural Control in Lowlanders Older Than 40 Years at Altitude NCT03536429	Phase 4	Completed	University of Zurich	99	2018-05-15 → 2018-08-02
Comparison Between Effect of Acetazolamide and NaHco3 in Prevention of Contrast Nephropathy NCT00634491	Phase 2	Completed	Shiraz University of Medical Sciences	240	2007-09 → 2008-02
Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude NCT01519544	N/A	Completed	Massachusetts General Hospital	34	2012-03 → 2015-03

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

Medicare Part B Spending

CMS physician-administered drug spending for Acetazolamide Sodium (2024)

Total Spending

$821.37

Total Claims

Beneficiaries

ASP Price

$25.51

Spending Trend

$349.65(2019)→$1K(2020)→$471.72(2021)→$334.35(2022)→$986.30(2023)→$821.37(2024)

YoY Change:+24.9%

5yr CAGR:+17.2%

HCPCS: J1120 — Injection, acetazolamide sodium, up to 500 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 24, 2024	SUPPL -39	View Letter (PDF)
May 16, 2022	SUPPL -38	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

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

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.