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TERCONAZOLE

NDA

TERCONAZOLE | N021735 | FOUGERA PHARMACEUTICALS 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Terconazole (2023)

Total Spending

$4.1M

Total Claims

122,626

Beneficiaries

84,152

Avg Cost/Unit

$2.07

Spending Trend

$4.5M(2019)→$4.4M(2020)→$4.2M(2021)→$4.2M(2022)→$4.1M(2023)

YoY Change:-10.1%

5yr CAGR:-2.7%

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

API Supply Chain4 active DMFs2 inactive

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

W.R. GRACE & CO.-CONNTERCONAZOLE

DMF 128871998

QUIMICA SINTETICA SATERCONAZOLE

DMF 146221999

DERIVADOS QUIMICOS SAUTERCONAZOLE

DMF 207352007

TARO PHARMACEUTICAL INDUSTRIES LTDTERCONAZOLE USP (MICRONIZED)

DMF 246632011

JANSSEN PHARMACEUTICA NVInactiveTERCONAZOLE (PRODUCT # R42470)

DMF 59251985

APOTECNIA SAInactiveTERCONAZOLE

DMF 156802001

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Aug 26, 2025	SUPPL -14	View Letter (PDF)
Jan 5, 2011	SUPPL -4	View Letter (PDF)
Oct 5, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.8%

RLDBX

0 patents0 exclusivities▴

CREAM;VAGINAL | Approved: Oct 1, 2004

No patent or exclusivity listings for this strength.