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CATAFLAM

NDA

DICLOFENAC POTASSIUM | N020142 | NOVARTIS PHARMACEUTICALS CORP

2 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

14 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-2487 · 10 docket documents Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Diclofenac Potassium Tablets, 12.5 mg suitable for submission in an Abbreviated New Drug Application, with	Suitability	2025-07-18	Denied	Senores Pharmaceuticals, Inc.
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-4134 · 11 docket documents Pharmobedient Consulting, LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.93 requesting that the FDA declare Diclofenac Potassium Tablets 37.5 mg suitable for submission in an Abbreviated New Drug Application. The proposed produc	Suitability	2024-08-29	Denied	Pharmobedient Consulting, LLC
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2779 · 12 docket documents On behalf of an unnamed client, the law firm Hyman, Phelps & McNamara filed a suitability petition under FDC Act Section 505(j)(2)(C) requesting that the FDA declare Diclofenac Potassium Tablets, 12.5 mg, suitable for submission as an ANDA, with the referenced listed drug being Novartis's CATAFLAM T	Suitability	2024-06-10	Denied	Hyman, Phelps & McNamara, P.C.
Attachment 1 current Orange Book entry for ZIPSOR Capsules re Suitability Pet... FDA-2023-P-4975 · 8 docket documents # Cannot Complete Summary I cannot provide the requested summary because the text provided does not contain the actual petition content. The material shown only includes a title and reference line indicating this is an attachment related to a suitability petition for ZIPSOR Capsules filed by Hyman,	Suitability	2023-11-13	Denied	Hyman, Phelps & McNamara, P.C.
Attachment 2 - ZIPSOR- diclofenac potassium capsule, liquid filled RE Suitabi... FDA-2023-P-4659 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed a citizen petition regarding ZIPSOR, a liquid-filled capsule formulation of diclofenac potassium, requesting a suitability determination for the drug product as part of the regulatory approval process.	Suitability	2023-10-23	Denied	Hyman, Phelps & McNamara, P.C.
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-4464 · 7 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Diclofenac Potassium Tablets, 12.5 mg, suitable for submission as an ANDA, with the reference liste	Suitability	2023-10-11	Denied	Hyman, Phelps & McNamara, P.C.
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-4444 · 7 docket documents The law firm Hyman, Phelps & McNamara, P.C., filed a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Diclofenac Potassium Tablets, 75 mg, suitable for submission as an ANDA, with the reference lis	Suitability	2023-10-11	Granted	Hyman, Phelps & McNamara, P.C.
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4282 · 12 docket documents Pharmobedient Consulting, LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Diclofenac Potassium Orally Disintegrating Tablets in 25 mg and 50 mg strengths suitable for submission as an Abbreviated New Drug Applica	Suitability	2023-10-03	Denied	Pharmobedient Consulting, LLC
Suitability Petition from Neuheit Pharma Technologies Pvt Ltd. FDA-2023-P-1988 · 10 docket documents Neuheit Pharma Technologies Pvt Ltd filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Levothyroxine sodium sublingual tablets in strengths of 25 mcg through 300 mcg are suitable for submission in an Abbreviat	Suitability	2023-05-17	Withdrawn	Neuheit Pharma Technologies Pvt Ltd.
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-0174 · 6 docket documents Hyman, Phelps & McNamara, P.C., filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Diclofenac Potassium Tablets, 12.5 mg, suitable for submission as an ANDA, with Novartis Pharmaceutical Corp.'s CATAFLAM (diclof	Suitability	2023-01-18	Withdrawn	Hyman, Phelps & McNamara, P.C.
Suitability Petition from Pharmobedient Consulting, LLC (on behalf of Amici P... FDA-2022-P-0052 · 9 docket documents Pharmobedient Consulting, LLC, on behalf of Amici Pharmaceuticals LLC, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an ANDA for Diclofenac Potassium Orally Disintegrating Tablets in 25 mg and 50 mg strengths, wh	Suitability	2022-01-06	Withdrawn	Amici Pharmaceuticals LLC
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0509 · 6 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Diclofenac Potassium Tablets, 75 mg, suitable for submission as an ANDA, with the reference listed drug being Novartis's	Suitability	2021-05-26	Withdrawn	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2018-P-4661 · 5 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition regarding Diclofenac Potassium Tablets, 50 mg, requesting that FDA designate ANDA 075219 as a new reference standard in the Orange Book because the current reference standard approved under ANDA 075463 is commercially unavailable due to manu	505(q)	2018-12-07	Denied	Hyman, Phelps & McNamara, P.C.
Citizen Petition from The Weinberg Group, Inc. FDA-2003-P-0127 · 4 docket documents The Weinberg Group, Inc. filed a suitability petition requesting that the FDA declare Diclofenac Potassium Capsules 25 mg suitable for submission as an ANDA, referencing the approved but discontinued Cataflam (diclofenac potassium) Tablets 25 mg (NDA 20-142), with the proposed product differing only	Other	2009-12-17	Withdrawn	The Weinberg Group, Inc.

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 Chain7 active DMFs4 inactive

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

YUNG ZIP CHEMICAL IND CO LTDDICLOFENAC POTASSIUM

DMF 108311994

OLON SPADICLOFENAC POTASSIUM

DMF 112671994

SYN-TECH CHEM AND PHARM CO LTDDICLOFENAC POTASSIUM USP

DMF 126561997

DIPHARMA FRANCIS SRLDICLOFENAC POTASSIUM

DMF 130451998

UNIQUE CHEMICALSDICLOFENAC POTASSIUM USP

DMF 150742000

AMOLI ORGANICS PRIVATE LTDDICLOFENAC POTASSIUM USP

DMF 230282009

HENAN DONGTAI PHARM CO LTDDICLOFENAC POTASSIUM

DMF 305152016

CHENG FONG CHEMICAL CO LTDInactiveDICLOFENAC POTASSIUM

DMF 119901996

ESTEVE QUIMICA SAInactiveDICLOFENAC POTASSIUM

DMF 120211996

FARCHEMIA SRLInactiveDICLOFENAC POTASSIUM

DMF 122171996

CAMBREX PROFARMACO CORK LTDInactiveDICLOFENAC POTASSIUM

DMF 139341999

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Apr 29, 2021	SUPPL -29	View Letter (PDF)
May 12, 2016	SUPPL -27	View Letter (PDF)
Feb 28, 2011	SUPPL -21	View Letter (PDF)
Feb 28, 2011	SUPPL -22	View Letter (PDF)
Mar 3, 2009	SUPPL -19	View Letter (PDF)
Jan 30, 2006	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

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

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 24, 1993

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;ORAL | Approved: Nov 24, 1993