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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Flector (2023)

Total Spending

$2.4M

Total Claims

3,437

Beneficiaries

937

Avg Cost/Unit

$11.12

Spending Trend

$2.6M(2021)→$2.8M(2022)→$2.4M(2023)

YoY Change:+7.3%

5yr CAGR:+5.0%

Source: CMS Medicare Part D Spending by Drug (2023). 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.