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Details for Generic Name: diclofenac sodium

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Diclofenac sodium is the generic ingredient in eight branded drugs marketed by Tolmar, Fougera Pharms, Novartis, Akorn, Alcon Pharms Ltd, Apotex Inc, Bausch And Lomb, Falcon Pharms, Nexus Pharms, Javelin Pharms Inc, Igi Labs Inc, Paddock Llc, Taro, Watson Labs Inc, Horizon Pharma, Nuvo Res Inc, Actavis Elizabeth, Carlsbad, Mylan Pharms Inc, Nostrum Labs, Pliva, Roxane, Sandoz, Teva, Teva Pharms, Unique Pharm Labs, Dexcel Ltd, Mylan, Valeant Intl, Gd Searle Llc, Actavis Labs Fl Inc, and Eagle Pharms, and is included in forty-one NDAs. There are sixteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and thirty-one patent family members in thirty-three countries.

There are forty-six drug master file entries for diclofenac sodium. Twenty-four suppliers are listed for this compound.

Summary for Generic Name: diclofenac sodium

Tradenames:8
Patents:16
Applicants:32
NDAs:41
Drug Master File Entries: see list46
Suppliers / Packaging: see list56
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Clinical Trials for: diclofenac sodium

Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel
Status: Completed Condition: Pain

Drug Interaction Study of Safinamide and a BCRP Substrate, Diclofenac, Concomitantly Administered to Healthy Volunteers
Status: Completed Condition: Healthy

A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea
Status: Completed Condition: Primary Dysmenorrhea

Pharmacokinetics Study Comparing Topical Diclofenac/Menthol Gels With Voltaren Gel and Oral Diclofenac Sodium
Status: Completed Condition: Pain

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® Gel 3% in the Treatment of Actinic Keratosis
Status: Completed Condition: Actinic Keratosis

Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate
Status: Completed Condition: Multiple Sclerosis

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain
Status: Terminated Condition: Ankle Sprain

Diclophenac Versus Placebo for Pain Control in Diagnostic Colonoscopy
Status: Recruiting Condition: Anemia

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis
Status: Completed Condition: Rotator Cuff Tendonitis; Bicipital Tendonitis; Subdeltoid Bursitis of the Shoulder; Subacromial Bursitis of the Shoulder; Medial Epicondylitis of the Elbow; Lateral Epicondylitis of the Elbow; DeQuervain's Tenosynovitis of the Wrist

Topical Diclofenac on Macular Thickness After Phacoemulsification
Status: Active, not recruiting Condition: Diabetic Oculopathy

A Study Comparing Diclofenac Sodium Gel 3% to Solaraze® (Diclofenac Sodium) Gel 3% in the Treatment of Actinic Keratosis
Status: Completed Condition: Actinic Keratosis

Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium
Status: Completed Condition: Healthy

Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
Status: Completed Condition: Ankle Sprain

Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium
Status: Completed Condition: Healthy

An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS
Status: Completed Condition: Pain; Delayed Onset Muscle Soreness

Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis

Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis
Status: Completed Condition: Osteoarthritis of the Knee

Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%
Status: Completed Condition: Osteo Arthritis of the Knee

A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain
Status: Recruiting Condition: Post Operative Dental Pain

Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin
Status: Terminated Condition: Breast Pain; Non-cyclical Mastalgia; Surgical Scar-Related Breast Pain

Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion
Status: Completed Condition: Acute Pain

Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants
Status: Completed Condition: Osteoarthritis of the Knee; Coagulopathy

Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
Status: Completed Condition: Acute Pain; Ankle Sprain

Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)
Status: Completed Condition: Acute Pain; Soft Tissue Injury

Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head
Status: Completed Condition: Photosensitivity Disorders

A Clinical Study in Healthy Male Volunteers to Compare the Bioequivalence of Fixed Dose Combination of Eperisone Hydrochloride 50mg Plus Diclofenac Sodium 50mg as Capsule With Eperisone Hydrochloride 50mg and Diclofenac Sodium 50mg Tablets Under Fasting Conditions (Study 013-10)
Status: Completed Condition: Healthy Volunteers

Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries
Status: Recruiting Condition: Athletic Injuries

Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers
Status: Completed Condition: Healthy

Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)
Status: Not yet recruiting Condition: Rheumatoid Arthritis

Diclofenac Administered Before Skull Operations Reduces the Severity of Headache After the Intervention
Status: Completed Condition: Postcraniotomy Headache; Intraoperative Analgesic Use; Postoperative Analgesic Use; Postoperative Complications

An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)
Status: Terminated Condition: Spondylitis, Ankylosing; Pain

Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device Insertion(IUD).
Status: Recruiting Condition: Pain

Evaluation of the Safety and Efficacy of PENNSAID Gel in the Treatment of Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis of the Knee

Injectable Diclofenac for the Prevention of Post-operative Dental Pain
Status: Completed Condition: Pain

Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain
Status: Recruiting Condition: Pain; Inadequate or Impaired Respiratory Function

A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol Gel
Status: Completed Condition: Pain

Effects of Pennsaid on Clinical Neuropathic Pain
Status: Active, not recruiting Condition: Neuralgia; Postherpetic Neuralgia; Reflex Sympathetic Dystrophy; Complex Regional Pain Syndrome (CRPS)

To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Status: Completed Condition: Inflammation

Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
Status: Not yet recruiting Condition: Actinic Keratosis (AK)

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
Status: Completed Condition: Ankle Sprain

To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets Under Non-Fasting Conditions
Status: Completed Condition: Inflammation

Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age
Status: Recruiting Condition: Pain, Postoperative

A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness
Status: Completed Condition: Muscle Soreness

Efficacy of PENNSAID® for Pain Management in the Emergency Department
Status: Withdrawn Condition: Pain; Ankle Sprain

Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip
Status: Terminated Condition: Osteoarthritis

Efficacy of Diclofenac on Pain During Endometrial Sampling
Status: Recruiting Condition: Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets
Status: Completed Condition: Inflammation

Relative Bioavailability of Dabigatran and Diclofenac After Dabigatran Etexilate and Diclofenac Single Dose Alone or Following Concomitant Multiple Oral Administrations in Healthy Male and Female Volunteers
Status: Completed Condition: Healthy

Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Status: Completed Condition: Osteoarthritis

Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
Status: Recruiting Condition: Pain

Pharmacokinetic Drug Interaction Between YH4808 and Diclofenac
Status: Completed Condition: Healthy

Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
Status: Completed Condition: Pain

A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain
Status: Completed Condition: Pain

Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections
Status: Terminated Condition: Fever

Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma
Status: Completed Condition: Basal Cell Carcinoma

Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy
Status: Completed Condition: Pain

Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn
Status: Completed Condition: Sunburn

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
Status: Completed Condition: Acute Ankle Sprain

Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Status: Completed Condition: Osteearthritis

Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
Status: Completed Condition: Osteoarthritis

Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Status: Completed Condition: Osteoarthritis

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
Status: Recruiting Condition: Acute Blunt Soft Tissue Injuries/Contusions

A Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
Status: Completed Condition: Ankylosing Spondylitis

Diclofenac vs. Ropivacaine for Cesarean Section
Status: Completed Condition: Cesarean Section

Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin
Status: Completed Condition: Non-melanomatous Skin Cancer

Topical Voltaren in Otitis Externa
Status: Suspended Condition: Otitis Externa

Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds
Status: Recruiting Condition: Migraine

Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Status: Completed Condition: Osteoarthritis

Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia
Status: Terminated Condition: Kidney Failure, Chronic; Arthralgia

The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.
Status: Completed Condition: Fever; Reduction in Temperature

A Clinical Trial to Study the Effects of a Fixed Dose Combination of Diclofenac and Eperisone Hydrochloride With Plain Eperisone Hydrochloride in Patients With Low Back Pain
Status: Completed Condition: Acute Musculoskeletal Spasm Due to Low Back Pain

Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial in Post ERCP Pancreatitis
Status: Completed Condition: Post-ERCP Acute Pancreatitis.

Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers
Status: Not yet recruiting Condition: Supersaturation and Precipitation in the Stomach

An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
Status: Active, not recruiting Condition: Pain, Postoperative

Effects of Topical Diclofenac on Tumor Metabolism
Status: Active, not recruiting Condition: Actinic Keratoses

Diclofenac Suppository to Control Pain During Flexible Cystoscopy
Status: Completed Condition: Pain; Hematuria; Lower Urinary Tract Symptoms

Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study)
Status: Active, not recruiting Condition: Graves´ Disease

Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine
Status: Active, not recruiting Condition: Breast Cancer

Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%
Status: Recruiting Condition: Knee Pain Chronic; Knee Injuries

A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction
Status: Completed Condition: Pain, Postoperative

Study of Diclofenac Capsules to Treat Dental Pain
Status: Completed Condition: Dental Pain

Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients
Status: Terminated Condition: Pancreatitis

Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy
Status: Recruiting Condition: Pain, Post Procedural; Pain, Procedural

Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy
Status: Recruiting Condition: Pain

Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy in Post Menopausal Women
Status: Recruiting Condition: Hysteroscopy; Pain

Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
Status: Completed Condition: Grade I/II Ankle Sprain

Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain
Status: Completed Condition: Ankle Sprain

Proof-of Concept Study of Topical 3%-Diclofenac-Nano-Emulsion Cream for Knee OA Pain
Status: Completed Condition: Osteoarthritis of the Knee

Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2)
Status: Completed Condition: Actinic Keratosis

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries
Status: Completed Condition: Acute Blunt Soft Tissue Injuries/Contusions

Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.
Status: Completed Condition: Osteoarthritis of Knee Joint

Diclofenac for Submassive PE
Status: Recruiting Condition: Pulmonary Embolism

Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Status: Completed Condition: Osteoarthritis

Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery
Status: Completed Condition: Dental Pain

Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
Status: Completed Condition: Dental Pain

Use of Etoricoxib Compared to Diclofenac in the Perioperative Treatment of Patients After Total Hip Arthroplasty
Status: Completed Condition: Coxarthrosis; Arthroplasties Hip Replacement; Perioperative Blood Loss

Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection
Status: Withdrawn Condition: Upper Respiratory Tract Infections

Study to Assess the Effectiveness and Safety of FLECTOR Patch for Treatment of Acute Back Strain
Status: Completed Condition: Acute Back Strain

Celecoxib Efficacy And Safety Versus Diclofenac In Acute Pain Due To Cervical Sprain Related To A Traffic Accident
Status: Terminated Condition: Pain

Study of Diclofenac Capsules to Treat Osteoarthritis Pain
Status: Completed Condition: Osteoarthritis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Pharms Ltd
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC078031-001Feb 6, 2008RXNo<disabled><disabled>
Nuvo Res Inc
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL020947-001Nov 4, 2009RXYes8,618,164<disabled><disabled>
Nexus Pharms
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION/DROPS;OPHTHALMIC078553-001Dec 28, 2007RXNo<disabled><disabled>
Watson Labs Inc
DICLOFENAC SODIUM
diclofenac sodium
SOLUTION;TOPICAL202852-001Nov 24, 2014RXNo<disabled><disabled>
Roxane
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074391-001Jun 29, 1995DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: diclofenac sodium

Country Document Number Publication Date
Czech Republic290637Sep 11, 2002
Hungary225967Jan 28, 2008
Germany69024039Dec 12, 2002
China102846585Jan 02, 2013
European Patent Office0626863Apr 25, 2001
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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