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VOLTAREN

NDA

DICLOFENAC SODIUM | N019201 | NOVARTIS PHARMACEUTICALS CORP

3 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 1 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years.NCT07663825	Phase 2	Not Yet Recruiting	University Hospital, Tours	34	2026-09 → 2030-10-31
Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain NCT07598994	N/A	Completed	Istanbul University	50	2025-08-28 → 2026-04-06
Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis NCT06257537	Phase 2	Completed	ZetrOZ, Inc.	307	2024-10-01 → 2026-06-26

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

Medicare Part D Spending

CMS annual spending data for Diclofenac Sodium* (2023)

Total Spending

$396.1M

Total Claims

8,423,585

Beneficiaries

3,196,668

Avg Cost/Unit

$0.38

Spending Trend

$11.1M(2019)→$251.9M(2019)→$13.1M(2020)→$275.3M(2020)→$11.7M(2021)→$250.5M(2021)→$303.6M(2022)→$14.8M(2022)→$10.9M(2023)→$396.1M(2023)

YoY Change:+20.5%

5yr CAGR:+2.2%

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

API Supply Chain12 active DMFs12 inactive

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

DIPHARMA FRANCIS SRLDICLOFENAC SODIUM EP/USP

DMF 66891986

YUNG ZIP CHEMICAL IND CO LTDDICLOFENAC SODIUM

DMF 69811987

CHENG FONG CHEMICAL CO LTDDICLOFENAC SODIUM

DMF 81921989

OLON SPADICLOFENAC SODIUM

DMF 89241991

SYN-TECH CHEM AND PHARM CO LTDDICLOFENAC SODIUM USP

DMF 98991992

UNIQUE CHEMICALSDICLOFENAC SODIUM USP

DMF 124691997

NINGBO SMART PHARMACEUTICAL CO LTDDICLOFENAC SODIUM

DMF 188772005

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DICLOFENAC SODIUM USP

DMF 208492007

HENAN DONGTAI PHARM CO LTDDICLOFENAC SODIUM

DMF 245802011

YUNG ZIP CHEMICAL IND CO LTDDICLOFENAC SODIUM (PROCESS II)

DMF 353632020

MACLEODS PHARMACEUTICALS LTDDICLOFENAC SODIUM USP

DMF 381552023

KREATIVE ORGANICS PRIVATE LTDDICLOFENAC SODIUM USP

DMF 424612025

HEUMANN PCS GMBHInactiveDICLOFENAC SODIUM

DMF 81211989

PROSINTEX SPAInactiveDICLOFENAC SODIUM

DMF 85831990

YONEZAWA HAMARI CHEMICALS LTDInactiveDICLOFENAC SODIUM

DMF 86881990

MEDICHEM SAInactiveDICLOFENAC SODIUM

DMF 89161991

ESTEVE QUIMICA SAInactiveDICLOFENAC SODIUM

DMF 91151991

IROTEC LABORATORIESInactiveDICLOFENAC SODIUM

DMF 103601993

ASSIA CHEMICAL INDUSTRIES LTDInactiveDICLOFENAC SODIUM

DMF 114991995

AMOLI ORGANICS LTDInactiveDICLOFENAC SODIUM

DMF 116761995

FARCHEMIA SRLInactiveDICLOFENAC SODIUM

DMF 117001995

EXCELLA GMBHInactiveDICLOFENAC SODIUM

DMF 151812000

ESTEVE QUIMICA SAInactiveDICLOFENAC SODIUM INJECTABLE GRADE/NON-STERILE

DMF 232002009

HAINAN POLY PHARMACEUTICAL CO LTDInactiveDICLOFENAC SODIUM EXTENDED RELEASE CAPSULES

DMF 232432009

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Apr 29, 2021	SUPPL -48	View Letter (PDF)
May 12, 2016	SUPPL -46	View Letter (PDF)
Feb 28, 2011	SUPPL -39	View Letter (PDF)
Feb 28, 2011	SUPPL -40	View Letter (PDF)
Feb 27, 2009	SUPPL -38	View Letter (PDF)
Jul 16, 2007	SUPPL -36	View Letter (PDF)
Jan 30, 2006	SUPPL -35	View Letter (PDF)
Nov 26, 2002	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Jul 28, 1988

No patent or exclusivity listings for this strength.

#002 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Jul 28, 1988

#003 — 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, DELAYED RELEASE;ORAL | Approved: Jul 28, 1988