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DIAMOX

NDA

ACETAZOLAMIDE | N008943 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D LLC

2 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
Suitability Petition from Appco Pharma LLC FDA-2026-P-4761 Appco Pharma LLC filed a suitability petition under section 505(j)(2)(C) requesting FDA approval to submit an Abbreviated New Drug Application for Acetazolamide Tablets, USP 500 mg, a strength that differs from the Reference Listed Drug, Diamox acetazolamide tablets approved in 125 mg and 250 mg str	Suitability	2026-05-01	Open	Appco Pharma LLC

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Acetazolamide ER (2023)

Total Spending

$6.4M

Total Claims

81,763

Beneficiaries

33,680

Avg Cost/Unit

$1.09

Spending Trend

$9.0M(2019)→$8.5M(2020)→$7.4M(2021)→$7.7M(2022)→$6.4M(2023)

YoY Change:-21.0%

5yr CAGR:-11.6%

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

API Supply Chain6 active DMFs3 inactive

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

ZAKLADY FARMACEUTYCZNE POLPHARMA SAACETAZOLAMIDE

DMF 103831993

IDT AUSTRALIA LTDACETAZOLAMIDE USP

DMF 129971998

NAKODA CHEMICALS LTDACETAZOLAMIDE

DMF 197632006

EMCURE PHARMACEUTICALS LTDACETAZOLAMIDE USP

DMF 202992007

CTX LIFE SCIENCES PVT LTDACETAZOLAMIDE USP

DMF 230142009

GLAND PHARMA LTDACETAZOLAMIDE

DMF 376162022

KV PHARMACEUTICAL COInactiveACETAZOLAMIDE 500MG SRC

DMF 25611975

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveACETAZOLAMIDE

DMF 28331977

CAMBREX PROFARMACO MILANO SRLInactiveACETAZOLAMIDE

DMF 46471982

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Oct 3, 2025	SUPPL -54	View Letter (PDF)
Sep 24, 2024	SUPPL -53	View Letter (PDF)
May 16, 2022	SUPPL -52	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982