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Data updated: May 26, 2026

PENNSAID (diclofenac sodium)

Pain Approved 2009-11-04
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2009-11-04
Patent Cliff
2030

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Patent cliff and revenue data

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Routes
TOPICAL
Dosage Forms
SOLUTION

Companies

NUVO PHARMS INC HORIZON
Active Ingredient: DICLOFENAC SODIUM

PENNSAID Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
19 FDA actions from 2009 to 2024
Nov 2024 SUPPL
Label · Labeling
FDA Letter Label
Jan 2022 SUPPL
Label · Labeling
FDA Letter Label
Jun 2021 SUPPL
Label · Labeling
FDA Letter Label

What PENNSAID Treats

2 FDA approvals

Originally approved for its first indication in 2009 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

27 trials
Trial Sponsor ID Phase Status Title
NCT07565012 DIPI-PEP AFID-OPER-PEP-2025-01 IRB Approval Number Ph 4 completed Comparative Evaluation of Diclofenac Sodium and Ibuprofen for Post-Endodontic Pain Management
NCT06207253 23-039 Ph 2, Ph 3 recruiting The Antimicrobial Potential of Diclofenac Sodium as an Intracanal Medicament
NCT06111573 YYU-10/31.05.2023 Ph 4 completed Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D on Myofascial Pain
NCT05829707 OsijekUH21 Ph 4 completed Long-term Outcomes of Breast Cancer Patients After Wound Infiltration Analgesia
NCT05626140 EDCLAS PIMS-05-002 Ph 3 completed COMPARISON OF EFFICACY OF DIFFERENT DRUG COMBINATIONS IN ACUTE SCIATICA
NCT05488925 BDC/ERB/2021/016 Ph 4 completed Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block.
NCT01962987 results posted 71204901 Ph 3 completed A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
NCT03825016 AS1855 Ph 2 completed Lidocaine Infusion in Hystroscopy
NCT03074162 results posted 1358.2 Ph 1 completed Comparison of the Bioavailability of Diclofenac in a Combination Product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) With Two Diclofenac Only Products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel, in Healthy Volunteers
NCT02598102 INU/RRC/01/2014-15 Ph 2 completed Efficacy of Preprocedural Diclofenac in Males Undergoing Double J Stent Removal Under Local Anesthesia
NCT03221946 PMVIDS&RC/IEC/OMR/PR 0051-15 Ph 4 completed A Comparative Evaluation of Diclofenac Sodium Transdermal Patch, Oral Diclofenac Sodium With Intramuscular Injections of Diclofenac Sodium in Patients Suffering From Oral Pain
NCT03090971 NX101-02-2016 Ph 2 completed Use of Topical Liquid Diclofenac Following Laser Microporation of Cutaneous Neurofibromas in Patients With NF1
NCT02201238 202188 RH02175 Ph 1 completed Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
NCT02611804 SYM 2015-01 Ph 3 completed A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
NCT00523120 HP 7-264S Ph 2 terminated Topical Voltaren in Otitis Externa
NCT02495831 results posted Z7219J01 Ph 1 completed Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers
NCT02658721 IVRA Ph 3 completed Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery
NCT02253446 MDhayri2014 Ph 4 completed A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea
NCT01706588 DP4 results posted 12UK/DCsc04 Ph 2 completed Injectable Diclofenac for the Prevention of Post-operative Dental Pain
NCT01511939 ATCCTCP-1 results posted ATCCTCP-1 Ph 3 completed Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants
NCT01858090 KA08/48 Ph 3 completed Intrathecal Levobupivacaine With Opioids for Caesarean Section
NCT01272934 results posted VOSG-P-318 Ph 3 completed Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
NCT01272947 results posted VOSG-P-319 Ph 3 completed Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries
NCT00931866 DCF-006 Ph 3 completed Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)
NCT00869180 SUPPORT 2 DCF-004 Ph 3 completed Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
NCT00805090 DFC-PK-009 Ph 1 completed Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects
NCT00640705 DCF-002 Ph 2, Ph 3 terminated Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PENNSAID FDA Label Details

View full patent landscape →
19 OB patents · 3 families · 71 international docs across 15 countries

PENNSAID Patents & Exclusivity

Latest Patent: Aug 2030

Patents (19 active)

US8546450 Expires Aug 9, 2030
US8217078 Expires Jul 10, 2029
US8618164 Expires Jul 10, 2029
US8741956 Expires Jul 10, 2029
US9370501 Expires Jul 10, 2029
US9375412 Expires Jul 10, 2029
US9415029 Expires Jul 10, 2029
US8252838 Expires Apr 21, 2028
US9132110 Expires Oct 17, 2027
US9168305 Expires Oct 17, 2027
US9066913 Expires Oct 17, 2027
US9339551 Expires Oct 17, 2027
US9220784 Expires Oct 17, 2027
US9339552 Expires Oct 17, 2027
US9539335 Expires Oct 17, 2027
US8563613 Expires Oct 17, 2027
US8871809 Expires Oct 17, 2027
US9101591 Expires Oct 17, 2027
US9168304 Expires Oct 17, 2027
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2030
  • • 25 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA020947 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.