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Details for Generic Name: ketorolac tromethamine

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Ketorolac tromethamine is the generic ingredient in eight branded drugs marketed by Amphastar Pharm, Apotex Inc, Apothecon, Bedford, Claris Pharmaservice, Eurohlth Intl Sarl, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Maple , Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sun Pharma Global, Wockhardt, Roche Palo, Allergan, Akorn, Alcon Pharms Ltd, Egalet Us Inc, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, and Omeros, and is included in forty-four NDAs. There are fourteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has fifty-six patent family members in twenty-two countries.

There are seventeen drug master file entries for ketorolac tromethamine. Eight suppliers are listed for this compound.

Summary for Generic Name: ketorolac tromethamine

Tradenames:8
Patents:14
Applicants:27
NDAs:44
Drug Master File Entries: see list17
Suppliers / Packaging: see list12
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ketorolac tromethamine

Clinical Trials for: ketorolac tromethamine

Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Status: Completed Condition: Postoperative Pain in Infants

Pharmacokinetics of Intranasal Ketorolac in Children
Status: Recruiting Condition: Evaluating Pharmacokinetics of Intranasal Ketorolac; Pain

Availability & Effect of Post-OP Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Status: Recruiting Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
Status: Recruiting Condition: Migraine

The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
Status: Completed Condition: Postoperative Pain

Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects
Status: Completed Condition: Healthy Subjects

A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
Status: Enrolling by invitation Condition: Chronic Pelvic Pain

Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain
Status: Completed Condition: Interstitial Cystitis

Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients
Status: Not yet recruiting Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers
Status: Completed Condition: Healthy Volunteers

Study of Whether 15 mg Dose of Ketorolac IV is as Effective as a 30 mg Dose.
Status: Recruiting Condition: Pain; Pain, Postoperative

Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy Pain
Status: Enrolling by invitation Condition: Post Vasectomy Pain

A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management
Status: Recruiting Condition: Pain

Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine
Status: Completed Condition: Migraines

Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients
Status: Completed Condition: Acute Pain

Assessment of Nasal Deposition and Clearance of Ketorolac Solution Administered Using the Valois Nasal Spray Device
Status: Completed Condition: Healthy Subjects

The Use of Intranasal Ketoralac for Pain Management
Status: Recruiting Condition: Postoperative Pain Management; Urolithiasis

Effect of Spinal Ketorolac on Mechanical Hypersensitivity After a Total Hip Replacement
Status: Terminated Condition: Hip Arthroplasty

Study of the Tolerability of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers
Status: Completed Condition: Healthy Volunteers

Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement
Status: Completed Condition: Pain Control With IUD Insertion

Disposition of Intravenous Ketorolac
Status: Completed Condition: Postoperative Pain

Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine
Status: Completed Condition: Migraine

Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders
Status: Recruiting Condition: DeQuervains Tenosynovitis; Lateral Epicondylitis; Tennis Elbow; Trigger Finger; Tenosynovitis; Inflammatory Disease

Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department
Status: Completed Condition: Probable Migraine; Migraine With Aura; Migraine Without Aura

Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries
Status: Not yet recruiting Condition: Postoperative Pain; Carpal Tunnel Release; Distal Radius Fracture

Dose Response of Ketorolac in Knee Arthroscopy
Status: Recruiting Condition: Meniscectomy

Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery
Status: Completed Condition: Cystoid Macular Edema Following Cataract Surgery, Bilateral

Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis
Status: Completed Condition: Allergic Rhinitis

Prospective Effect of Intravenous Ketorolac on Opioid Use and Complications Following Cesarean Delivery
Status: Not yet recruiting Condition: Analgesia, Obstetrical

Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers
Status: Completed Condition: Healthy Volunteers

Effect of Spinal Ketorolac After Acute Opioid Exposure
Status: Terminated Condition: Healthy

An Efficacy and Safety Trial of Intranasal Ketorolac in Emergency Department Patients for the Treatment of Acute Pain
Status: Active, not recruiting Condition: Other Acute Pain

Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage
Status: Completed Condition: Pain

Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
Status: Completed Condition: Cataract

Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain
Status: Completed Condition: Postoperative Pain

A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
Status: Completed Condition: Cataracts

Effect of Morphine, Tramadol, and Ketorolac on Postoperative Stress and Immune Responses
Status: Active, not recruiting Condition: Breast Cancer

ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management
Status: Recruiting Condition: Postoperative Pain

Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
Status: Completed Condition: Open Angle Glaucoma

Study to Assess the Pharmacokinetics of Ketorolac Tromethamine and to Assess the Effects of a Oxymetazoline Hydrochloride on the Pharmacokinetics of Ketorolac Tromethamine
Status: Completed Condition: Healthy Subjects

Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery
Status: Completed Condition: Pain Management Following Cardiopulmonary Bypass Surgery

Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy
Status: Completed Condition: Renal Calculus; Kidney Stones

Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy
Status: Completed Condition: Nephrectomy; Laparoscopic Donor Nephrectomy

Ketorolac Versus Triamcinolone Knee Injections for Osteoarthritis
Status: Completed Condition: Knee Osteoarthritis

A Randomized Controlled Trial of IV Ketorolac to Prevent Post-ERCP Pancreatitis
Status: Not yet recruiting Condition: Pancreatitis

Modulation of Remifentanil-induced Postinfusion Hyperalgesia
Status: Completed Condition: Hyperalgesia, Secondary

Artificial Tears Versus Preservative Free Ketorolac Trometamol 0.45% for Acute Viral Conjunctivitis
Status: Completed Condition: Conjunctivitis, Viral

Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures
Status: Completed Condition: Pain

Metoclopramide Versus Ketorolac for Tension-type Headache
Status: Completed Condition: Headache

Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy
Status: Completed Condition: Proliferative Diabetic Retinopathy; Macular Edema

Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
Status: Enrolling by invitation Condition: Retinopathy of Prematurity; Retinal Detachment; Blindness

Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery
Status: Completed Condition: Pain

Prophylactic Ketorolac Post Epiretinal Membrane Surgery
Status: Completed Condition: Macular Edema

A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification
Status: Completed Condition: Cataracts

Efficacy Parecoxib and Ketorolac as Preemptive Analgesia in Spine Fusion
Status: Completed Condition: Postoperative Pain

Safety and Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain
Status: Completed Condition: Postoperative Pain

Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects
Status: Completed Condition: Healthy Subjects

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

Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease
Status: Terminated Condition: Hematologic Diseases; Anemia, Sickle Cell

A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty
Status: Completed Condition: Postoperative Pain

The Effect of Prophylactic Ketorolac on Sore Throat After Thyroid Surgery
Status: Recruiting Condition: Anesthesia Intubation Complication; Tracheal Disease

Ketorolac in Breast Cancer Surgery
Status: Recruiting Condition: Curative Breast Cancer Surgery; Inflammatory Positive/Negative Status; Pre Surgical Incision Administration

Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
Status: Active, not recruiting Condition: Cataract

A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)
Status: Completed Condition: Post Operative Anterior Chamber Inflammation (Flare)

The Role of Prostaglandins in the Progression of Diabetic Retinopathy
Status: Recruiting Condition: Inflammation

Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
Status: Completed Condition: Postoperative Pain

Perioperative Ketorolac-lidocaine in the Patients With Valvular Heart Diseases During Cesarean Delivery
Status: Recruiting Condition: Valve Heart Disease; Elective Cesarean Delivery

A Randomized Trial of Valproate Versus Ketorolac Versus Metoclopramide for Acute Migraine
Status: Recruiting Condition: Acute Migraine

Topical 0.4% Ketorolac and Vitreoretinal Surgery
Status: Completed Condition: Surgery

Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Status: Recruiting Condition: Back Pain

Intravitreal Ketorolac for Chronic Uveitis: A Investigational Safety Study
Status: Completed Condition: Inflammation

Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Status: Not yet recruiting Condition: Back Pain

Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery
Status: Completed Condition: Cataract

The Use of Ketorolac in Surgical Neonates
Status: Not yet recruiting Condition: Postoperative Pain Control in Surgical Neonates

SPRIX in 0 to 11 Year-Old Patients Undergoing Open Surgical Procedures
Status: Active, not recruiting Condition: Pain

Preemptive Ketorolac for Shoulder Tip Pain During Cesarean Section
Status: Completed Condition: Cesarean Section

Pilot Study of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
Status: Completed Condition: Wet Macular Degeneration

Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation
Status: Withdrawn Condition: Pain

Post-Operative Treatment With Ketorolac After Abdominal Myomectomy
Status: Completed Condition: Febrile Morbidity; Pain

Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Status: Completed Condition: Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic

Ketolorac Versus Saline at Laparoscopic Incision Sites
Status: Withdrawn Condition: Pain, Postoperative

A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery
Status: Completed Condition: Pain; Dental Impaction

RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child
Status: Not yet recruiting Condition: Fracture; Pain

Assessment and Prevention of Acute Post-herniotomy Pain
Status: Completed Condition: Hernia

A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
Status: Completed Condition: Must be PRK Candidate

Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification
Status: Completed Condition: Cystoid Macular Edema; Cataract

A Brain Imaging Study of Opioid (Morphine) and Non-opioid (Ketorolac) Conditioning Effects
Status: Recruiting Condition: Healthy Controls

Prochlorperazine Versus Prochlorperazine & Ketorolac in Treatment of Pediatric Migraine in the Emergency Department
Status: Withdrawn Condition: Migraine

Effect of Ketorolac and Remote Ischemic Preconditioning on Renal Ischemia-reperfusion Injury in Patients Undergoing Partial Nephrectomy
Status: Completed Condition: Renal Cell Carcinoma

Ketorolac Effects on Post-operative Pain and Bone Healing
Status: Recruiting Condition: Bunion

Sublingual Analgesia for Acute Abdominal Pain in Children
Status: Recruiting Condition: Abdominal Pain

Paracervical Block in First Trimester Surgical Abortions
Status: Completed Condition: Pain; Surgical Abortion

KITS Study -Ketorolac In Tonsillectomy Surgery: a Double Blinded, Randomized Clinical Trial
Status: Recruiting Condition: Recurrent Acute Tonsillitis

Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic
Status: Recruiting Condition: Renal Colic

Magnesium Sulfate Improves Postoperative Analgesia in Laparoscopic Gynecologic Surgeries
Status: Completed Condition: Pain, Postoperative

Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
Status: Completed Condition: Cataracts

Efficacy of Ketorolac 0.4% in Prostaglandin Suppression
Status: Completed Condition: Inflammation

Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
Status: Completed Condition: Cataract; Inflammation

Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty
Status: Completed Condition: Primary Open Angle Glaucoma; Pseudo-exfoliative Glaucoma

Prophylactic Nepafenac and Ketorolac Versus Placebo in Patients Undergoing Cataract Surgery
Status: Completed Condition: Macular Edema

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
Bedford
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION075228-001Apr 26, 1999DISCNNo<disabled><disabled>
Mylan Labs Ltd
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION078299-002Jul 16, 2007RXNo<disabled><disabled>
Fresenius Kabi Usa
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION075784-002Jan 11, 2002RXNo<disabled><disabled>
Hospira
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION074802-001Jun 5, 1997RXYes<disabled><disabled>
Apotex Inc
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION077201-001Oct 14, 2005DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: ketorolac tromethamine

Country Document Number Publication Date
Japan2007501799Feb 01, 2007
Italy1250691Apr 21, 1995
World Intellectual Property Organization (WIPO)2005014046Feb 17, 2005
European Patent Office2555770Feb 13, 2013
Malaysia150250Dec 31, 2013
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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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