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NAFTIN

NDA

NAFTIFINE HYDROCHLORIDE | N019356 | LEGACY PHARMA 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 Naftin (2023)

Total Spending

$2.4M

Total Claims

4,016

Beneficiaries

1,900

Avg Cost/Unit

$10.53

Spending Trend

$2.5M(2019)→$2.0M(2020)→$2.2M(2021)→$2.9M(2022)→$2.4M(2023)

YoY Change:+2.5%

5yr CAGR:+5.3%

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

API Supply Chain7 active DMFs

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

ERREGIERRE SPANAFTIFINE HYDROCHLORIDE USP

DMF 147112000

NOVARTIS PHARMA AGNAFTIFINE HYDROCHLORIDE

DMF 167722003

OLON SPANAFTIFINE HYDROCHLORIDE

DMF 181472005

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTDNAFTIFINE HYDROCHLORIDE

DMF 234562010

TARO PHARMACEUTICAL INDUSTRIES LTDNAFTIFINE HYDROCHLORIDE USP

DMF 246192012

CHONGQING HUAPONT PHARMACEUTICAL CO LTDNAFTIFINE HYDROCHLORIDE

DMF 287352014

MSN LABORATORIES PRIVATE LTDNAFTIFINE HYDROCHLORIDE USP [ROUTE CODE "NT"]

DMF 289312015

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 3, 2018	SUPPL -8	View Letter (PDF)
Oct 4, 2007	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jun 18, 1990

No patent or exclusivity listings for this strength.