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FLECTOR

NDA

DICLOFENAC EPOLAMINE | N021234 | IBSA INSTITUT BIOCHIMIQUE SA

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine NCT01380353	Early Phase 1	Completed	Northwestern University	30	2011-06 → 2012-11-12
Evaluation of Bioavailability of Diclofenac Dermal Products NCT03145259	Early Phase 1	Completed	University of Maryland, Baltimore	12	2017-04-19 → 2020-05-15
Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain NCT02324270	Phase 3	Completed	Actavis Inc.	658	2014-05 → 2014-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$4.96

per ea

Lowest NADAC/Unit

$4.96

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00093372755DICLOFENAC EPOLAMINE 1.3% PTCH	$4.96	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (3 FSS, 1 Big4)

Lowest Price

$65.98

Highest Price

$229.86

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00093-3727-55DICLOFENAC EPOLAMINE 1.3% PATCH	$125.17	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-3727-55DICLOFENAC EPOLAMINE 1.3% PATCH	$90.94	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
71858-0405-05FLECTOR 1.3% PATCH	$229.86	FSS	IBSA Pharma Inc.	06/30/2026
82347-0405-05DICLOFENAC EPOLAMINE 1.3% PATCH	$65.98	FSS	Yaral Pharma, Inc.	04/30/2028

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

Medicare Part D Spending

CMS annual spending data for Flector (2024)

Total Spending

$1.7M

Total Claims

2,533

Beneficiaries

629

Avg Cost/Unit

$10.19

Spending Trend

$2.6M(2021)→$2.8M(2022)→$2.4M(2023)→$1.7M(2024)

YoY Change:-8.4%

5yr CAGR:+0.3%

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

API Supply Chain4 active DMFs3 inactive

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

YUNG ZIP CHEMICAL IND CO LTDDICLOFENAC EPOLAMINE

DMF 239092010

SYN-TECH CHEM AND PHARM CO LTDDICLOFENAC EPOLAMINE

DMF 249622011

AMOLI ORGANICS PVT LTDDICLOFENAC EPOLAMINE

DMF 252242011

CAMBREX CHARLES CITY INCDICLOFENAC EPOLAMINE

DMF 261122012

CADILA HEALTHCARE LTDInactiveDICLOFENAC EPOLAMINE

DMF 245222011

DIPHARMA FRANCIS SRLInactiveDICLOFENAC EPOLAMINE

DMF 256772012

AARTI DRUGS LTDInactiveDICLOFENAC EPOLAMINE

DMF 259292012

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2024	SUPPL -24	View Letter (PDF)
Apr 30, 2021	SUPPL -19	View Letter (PDF)
Mar 7, 2019	SUPPL -16	View Letter (PDF)
Mar 7, 2019	SUPPL -17	View Letter (PDF)
Sep 13, 2018	SUPPL -15	View Letter (PDF)
May 11, 2016	SUPPL -14	View Letter (PDF)
May 11, 2016	SUPPL -13	View Letter (PDF)
Feb 28, 2011	SUPPL -9	View Letter (PDF)
Feb 4, 2011	SUPPL -8	View Letter (PDF)
Feb 4, 2011	SUPPL -5	View Letter (PDF)
Nov 10, 2009	SUPPL -6	View Letter (PDF)
Oct 28, 2008	SUPPL -4	View Letter (PDF)
Jun 6, 2008	SUPPL -3	View Letter (PDF)
Feb 12, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.3%

RLD

0 patents0 exclusivities▴

SYSTEM;TOPICAL | Approved: Jan 31, 2007

No patent or exclusivity listings for this strength.