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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

4 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Amendment to Suitability Petition from Laboflex Inc. FDA-2025-P-4911 · 10 docket documents Laboflex Inc. filed an amendment to its ANDA suitability petition for Diclofenac Sodium Plaster, 1%, addressing the FDA's concerns regarding discrepancies between the proposed labeling and the reference listed drug regarding frequency of administration and maximum plaster usage, and submitted revise	Suitability	2025-12-17	Denied	Laboflex Inc.
Citizen Petition from Yiling Pharmaceutical Ltd FDA-2018-P-2901 · 4 docket documents Yiling Pharmaceutical Ltd filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA select a different listed drug as the reference standard for VOLTAREN diclofenac sodium delayed-release tablets in 75mg, 50mg, and 25mg strengths to be used in conducting in vivo bioequivale	505(q)	2018-07-27	Open	Yiling Pharmaceutical Ltd
Citizen Petition from Kratz & Barry LLP on behalf of Rubicon Research Private... FDA-2018-P-1263 · 6 docket documents Kratz & Barry LLP, on behalf of Rubicon Research Private Limited, filed a citizen petition under Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA designate Diclofenac Sodium delayed release tablets in 25 mg and 50 mg strengths held by Unique Pharmaceutical Laboratori	Other	2018-03-26	Open	Rubicon Research Private Limited
King and Spalding LLP - Citizen Petition FDA-2007-P-0348 · 7 docket documents King & Spalding LLP filed a suitability petition under Section 505(j)(2)(C) requesting that the FDA declare a new enteric-coated capsule dosage form containing diclofenac sodium and misoprostol in 50 mg/200 mcg and 75 mg/200 mcg combinations suitable for submission via ANDA, with the reference liste	Other	2008-05-23	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

256 trials from ClinicalTrials.gov — 1 recruiting, 200 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Diclofenac for Prevention of Post-ERC Pancreatitis NCT03595150	Phase 2/3	Not Yet Recruiting	Karolinska Institutet	1,000	2026-01-01 → 2028-12-31
Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis NCT01579890	—	APPROVED_FOR_MARKETING	Mallinckrodt	—	—
Cabbage Leaf Wraps in Osteoarthritis of the Knee NCT02027792	N/A	Completed	Universität Duisburg-Essen	81	2014-01 → 2014-08
Safety and Efficacy of SFPP in Knee Osteoarthritis NCT03434197	Phase 3	Completed	Taisho Pharmaceutical Co., Ltd.	313	2018-02-05 → 2021-01-11
Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty NCT03605914	Phase 4	Completed	The University of Texas Health Science Center, Houston	100	2018-08-01 → 2020-07-05
Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain NCT02445599	Phase 4	Completed	University of Debrecen	3	2014-04 → 2016-04
Diclofenac Potassium Alone Versus Diclofenac Potassium With Hyoscine-N-butyl Bromide (HBB in Endoscopy NCT04125771	N/A	Completed	Aljazeera Hospital	64	2020-02-16 → 2020-10-01
Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis NCT01119898	Phase 2	Completed	Mallinckrodt	260	2010-08-02 → 2011-02-16
Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%NCT00595543	Phase 4	Completed	Bp Consulting, Inc	166	2008-01 → 2009-03
Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis NCT00640939	Phase 2/3	Completed	Cerimon Pharmaceuticals	308	2007-12 → 2008-06

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

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