Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-00397	8999387	IPR	Lupin Pharmaceuticals, Inc. et al.	Institution Denied	2015-12-28	—
IPR2016-00399	9017721	IPR	Lupin Pharmaceuticals, Inc. et al.	Institution Denied	2015-12-28	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
iCeutica Pty Ltd. et al v. Apotex, Inc. et al 1:2017cv01553 7 patentsANDA 210299diclofenac	D. Del.	2017-10-31	Terminated 2018-06-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

8 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 1 - Diclofenac Potassium Tablets, USP 12.5 mg RE: Suitability Peti... FDA-2023-P-4464 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Diclofenac Potassium Tablets, USP 12.5 mg, seeking a determination of regulatory suitability for the drug product under FDA's abbreviated new drug application (ANDA) pathway.	Suitability	2023-10-30	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.
Attachment 3 Diclofenac Potassium Tablets Warning re Suitability Petition fro... FDA-2023-P-4444 · 7 docket documents Hyman Phelps & McNamara, P.C. filed a petition requesting that the FDA issue a warning regarding the suitability of diclofenac potassium tablets. The petition seeks FDA action to communicate safety or suitability concerns related to this nonsteroidal anti-inflammatory drug product to healthcare prov	Suitability	2023-10-11	Granted	Hyman Phelps & McNamara, P.C.
Attachment 2 DICLOFENAC POTASSIUM re Suitability Petition from Pharmobedient ... FDA-2023-P-4282 · 12 docket documents Pharmobedient Consulting, LLC filed a suitability petition regarding diclofenac potassium, requesting that the FDA determine the suitability of this active pharmaceutical ingredient for use in drug products and establish appropriate regulatory pathways for its approval.	Suitability	2023-10-03	Denied	Pharmobedient Consulting, LLC
Attachment 6 - Drugs and Supplements DICLOFENAC (Oral Route) RE Suitability P... FDA-2021-P-0344 · 14 docket documents Zydus Pharmaceuticals USA Inc filed a suitability petition regarding oral diclofenac, requesting FDA determination on the suitability of the drug product for abbreviated new drug application (ANDA) approval and manufacturing processes.	Suitability	2022-08-12	Withdrawn	Zydus Pharmaceuticals USA Inc
Attachment 2 - DICLOFENAC POTASSIUM TABLETS USP, 50 mg RE Suitability Petitio... FDA-2022-P-0052 · 9 docket documents Pharmobedient Consulting, LLC, on behalf of Amici Pharmaceuticals LLC, filed a petition requesting a suitability determination for diclofenac potassium tablets USP 50 mg to establish reference standards for regulatory purposes under an ANDA submission pathway for generic drug approval.	Suitability	2022-01-06	Withdrawn	Amici Pharmaceuticals LLC
Attachment 2 - CATAFLAM PI (diclofenac potassium immediate-release tablets) R... FDA-2021-P-0509 · 6 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Cataflam (diclofenac potassium immediate-release tablets), requesting that the FDA determine the suitability of the product's prescribing information for use as a reference standard in evaluating generic drug applications.	Suitability	2021-05-26	Withdrawn	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Fish & Richardson PC FDA-2018-P-0343 · 3 docket documents Fish & Richardson PC, on behalf of Iroko Pharmaceuticals LLC, filed this citizen petition requesting that the FDA refuse to approve ANDA No. 210299 submitted by Apotex Inc. for diclofenac sodium capsules under sections 505(j)(4)(C)(i) and 505(j)(4)(G) of the Federal Food, Drug, and Cosmetic Act, arg	505(q)	2018-01-24	Denied	Fish & Richardson PC

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 DMFs

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

AMSA SPADICLOFENAC HYDROXY ETHYL PYRROLIDINE

DMF 148312000

UNIQUE CHEMICALS (A DIV OF J B CHEMICALS AND PHARMACEUTICALS LTD)DICLOFENAC ACID

DMF 153662001

UNIQUE CHEMICALSDICLOFENAC DIETHYAMINE

DMF 190202006

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

DMF 236802010

YUNG ZIP CHEMICAL IND CO LTDDICLOFENAC ACID

DMF 251072011

COSMA SPADICLOFENAC HYDROXY ETHYL PYRROLIDINE

DMF 273222014

AMOLI ORGANICS PVT LTDDICLOFENAC

DMF 282082014

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2024	SUPPL -14	View Letter (PDF)
Apr 30, 2021	SUPPL -13	View Letter (PDF)
May 10, 2016	SUPPL -8	View Letter (PDF)
May 10, 2016	SUPPL -7	View Letter (PDF)
Aug 27, 2014	SUPPL -2	View Letter (PDF)
Aug 27, 2014	SUPPL -4	View Letter (PDF)
Oct 22, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

7 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Oct 18, 2013

Patents (7) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8679544	Apr 23, 2030	—	—	Yes	—	—
8999387	Apr 23, 2030	—	—	—		—
9017721	Apr 23, 2030	—	—	Yes	—	—
9173854	Apr 23, 2030	—	—	Yes	—	—
9180095	Apr 23, 2030	—	—	—		—
9180096	Apr 23, 2030	—	—	Yes	—	—
9186328	Apr 23, 2030	—	—	—		—

#002 — 35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

7 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Oct 18, 2013