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Details for Generic Name: prednisolone acetate

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Prednisolone acetate is the generic ingredient in eighteen branded drugs marketed by Schering, Akorn, Bel Mar, Cent Pharms, Watson Labs, Pfizer, Alcon, Allergan, Taro, Pharmafair, Novartis, and Bausch And Lomb, and is included in twenty-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-four patent family members in fourteen countries.

There are seventy-nine drug master file entries for prednisolone acetate. Twelve suppliers are listed for this compound.

Summary for Generic Name: prednisolone acetate

Tradenames:18
Patents:5
Applicants:12
NDAs:27
Drug Master File Entries: see list79
Suppliers: see list12
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Inflammatory Bowel Disease Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: prednisolone acetate

Clinical Trials for: prednisolone acetate

A Comparison of Three Different Formulations of Prednisolone Acetate 1%
Status: Completed Condition: Glaucoma; Cataract

A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
Status: Completed Condition: Eye Infections; Postoperative Complications

Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.
Status: Completed Condition: Cataracts; Corneal Edema; Retinal Structural Change, Deposit and Degeneration; Visual Acuity Reduced Transiently

Efficacy and Tolerability of Prednisolone Acetate 0.5% Cream Versus Betamethasone Valerate 0.1% Cream in Cortisosensitive Dermatosis
Status: Not yet recruiting Condition: Dermatitis, Atopic; Dermatitis, Contact; Dermatitis, Seborrheic; Psoriasis

Prednisolone Priming Study in Patients With Chronic Hepatitis B
Status: Recruiting Condition: Chronic Hepatitis B

Biomarkers of Prednisolone Treatment (P05888)
Status: Completed Condition: Insulin Resistance; Hyperglycemia; Glucose Intolerance

Preoperative Methylprednisolone in Endovascular Aortic Repair
Status: Completed Condition: Abdominal Aortic Aneurysms

The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia
Status: Completed Condition: Eosinophilic Pneumonia; Chronic Disease

Methylprednisolone N Acetylcysteine in Hepatic Resections
Status: Terminated Condition: Ischemic Reperfusion Injury; Insufficiency; Hepatic, Postoperative; Liver Tumour

Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone
Status: Terminated Condition: Multiple Sclerosis

A Study to Compare Ocular Safety and Tolerability of Eye Drops Containing Prednisolone Acetate in Patients With Intraocular Inflammation After Cataract Surgery
Status: Completed Condition: Cataract Surgery

Evaluation of Efficacy of Coadministration of FOV1101-00 and Prednisolone Acetate in Patients With Mild Ongoing Ocular Allergic Inflammation
Status: Completed Condition: Allergic Conjunctivitis

Cyclic Oral Methylprednisolone Trial in Multiple Sclerosis
Status: Completed Condition: Progressive Multiple Sclerosis

Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)
Status: Suspended Condition: Acute Exacerbation of Remitting Relapsing Multiple Sclerosis; Clinically Isolated Syndrome

Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
Status: Completed Condition: Infection and Inflammation After Refractive Surgery (Lasik).

Prednisolone Pharmacokinetics in Severe Asthma
Status: Completed Condition: Asthma

Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS
Status: Recruiting Condition: Infertility; Polycystic Ovarian Syndrome

Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms
Status: Not yet recruiting Condition: Infantile Spasms

Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus
Status: Recruiting Condition: Stomatitis; Oral Mucositis; Neoplasm of the Breast; Malignant Tumor of Breast

Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery
Status: Completed Condition: Cataracts; Inflammation

Efficacy of Moxifloxacin/Prednisolone in Prevention of Post Surgery Inflammation
Status: Not yet recruiting Condition: Eye Infection/Inflammation Other

Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
Status: Terminated Condition: Refractory Mycoplasma Pneumoniae Pneumonia

Oral Prednisolone Dosing in Children Hospitalized With Asthma
Status: Completed Condition: Asthma

Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis
Status: Completed Condition: Allergic Conjunctivitis

A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
Status: Active, not recruiting Condition: Prostate Cancer

A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP.
Status: Recruiting Condition: Immune Thrombocytopenic Purpura

Study of SB681323 and Prednisolone on Biomarkers in COPD (Chronic Obstructive Pulmonary Disease) Patients
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive

Efficacy of Methylprednisolone for Hantavirus Cardiopulmonary Syndrome
Status: Completed Condition: Hantavirus Infections

Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
Status: Recruiting Condition: Cataract

A Study to Compare Ocular Safety and Tolerability of Prednisolone Acetate 0.5% Eye Drops Versus Vehicle in Healthy Volunteers
Status: Completed Condition: Healthy

Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge Model
Status: Completed Condition: Allergic Conjunctivitis

Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis
Status: Enrolling by invitation Condition: Rheumatoid Arthritis

Effect of Methylprednisolone on Quadriceps Muscle Function in Patients Undergoing Total Knee-arthroplasty
Status: Recruiting Condition: Osteoarthrosis

Effect of Methylprednisolone on Complement Activation in Patients Undergoing Total Knee-arthroplasty
Status: Recruiting Condition: Osteoarthrosis

Effect of Methylprednisolone on Endothelial Function in Patients Undergoing Total Knee-arthroplasty
Status: Recruiting Condition: Osteoarthrosis

Effect of Methylprednisolone on Glucose Homeostasis in Patients Undergoing Total Hip- and Knee-arthroplasty
Status: Recruiting Condition: Osteoarthrosis

Methylprednisolone Addition in IVF Treatment of Infertile Couples
Status: Recruiting Condition: In Vitro Fertilization

Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis
Status: Completed Condition: Rheumatoid Arthritis

Effect of Dexamethasone and Methylprednisolone on Pain, Swelling and Trismus After Third Molar Surgery
Status: Completed Condition: Pain,; Edema,; Trismus

Effects of Methylprednisolone After Total Knee Arthroplasty
Status: Completed Condition: Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response

Effects of Methylprednisolone After Total Hip Arthroplasty
Status: Completed Condition: LOS; Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response

Dexamethasone Versus Depo Medrol in Lumbar Epidurals
Status: Terminated Condition: Lumbar Spine Disc Herniation; Lumbar Radiculitis; Lumbar Back Pain

The Effect of a Preoperative Single-dose Methylprednisolone on the Postoperative Rehabilitation After Abdominal Hysterectomy
Status: Completed Condition: Hysterectomy; Methylprednisolone; Postoperative Pain

Effects and Safety of Infusion of Low-Doses of Methylprednisolone in Early ALI and ARDS in Children
Status: Not yet recruiting Condition: Acute Lung Injury; Acute Respiratory Distress Syndrome

Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease
Status: Recruiting Condition: Minimal Change Disease

Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis
Status: Recruiting Condition: Acute Alcoholic Hepatitis

Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis
Status: Recruiting Condition: Subacromial Bursitis; Shoulder Pain

Arthralgia of the Temporomandibular Joint. Pain Relief Following One Intra-articular Injection of Methylprednisolone
Status: Recruiting Condition: Arthralgia; TMJ

A Trial of Adjunctive Prednisolone and Mycobacterium w Immunotherapy in Tuberculous Pericarditis
Status: Completed Condition: Tuberculous Pericarditis

Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Status: Completed Condition: Leprosy

Treatment of Renal Sarcoidosis by Methylprednisolone Bolus
Status: Recruiting Condition: Renal Sarcoidosis

CRx-102 Osteoarthritis Multicenter Evaluation Trial
Status: Terminated Condition: Knee Osteoarthritis

Pharmacokinetics of Prednisone, Prednisolone, Methylprednisolone in Children
Status: Recruiting Condition: Children Receiving Prednisone or Prednisolone or Methylprednisolone

Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee
Status: Completed Condition: Osteoarthritis of the Knee

Ciclosporin in the Management of New Type 1 Reactions in Leprosy
Status: Completed Condition: Leprosy

Ciclosporin in the Management of New Erythema Nodosum Leprosum
Status: Completed Condition: Leprosy

Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis
Status: Completed Condition: Anterior Uveitis

Topical Treatment of Uveitic Macular Edema
Status: Not yet recruiting Condition: Uveitis; Cystoid Macular Edema

A Proof of Concept Study to Determine the Local Delivery and Efficacy of Nanocort
Status: Recruiting Condition: Atherosclerosis

Clinical Study to Assess the Effects of SRT2104 and Prednisolone on Biomarkers in Blood in Healthy Volunteers
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive; Healthy Volunteer

Systemic Methylprednisolone in Chronic Rhinosinusitis
Status: Completed Condition: Chronic Rhinosinusitis; Children

Efficacy and Safety of MEthylprednisolone Administered Intravenously for the Treatment of Patients With Active AnkyLosing spondyLitis (METALL)
Status: Active, not recruiting Condition: Ankylosing Spondylitis

Study of T-PRED(TM) Compared to Pred Forte(R)
Status: Completed Condition: Cataract

A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
Status: Recruiting Condition: Non-infectious Anterior Uveitis

Prevention of Noise-induced Hearing Loss
Status: Not yet recruiting Condition: Noise-induced Hearing Loss

High-dose Methylprednisolone and Rituximab in High Risk B-CLL
Status: Completed Condition: Chronic B-Lymphocytic Leukemia

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

Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
Status: Completed Condition: Endogenous Anterior Uveitis

Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer
Status: Withdrawn Condition: Lung Cancer

Prednisone and Acupuncture for the Treatment of Facial Neuritis: a Multiple Center, CER in China
Status: Recruiting Condition: Bell's Palsy

A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets
Status: Withdrawn Condition: Therapeutic Equivalency

A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.
Status: Completed Condition: Arthritis, Rheumatoid

A Bioequivalence Study Comparing Methylprednisolone Suspension to Methylprednisolone Tablets Under Fed Conditions
Status: Withdrawn Condition: Therapeutic Equivalency

A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions
Status: Withdrawn Condition: Therapeutic Equivalency

To Study the Effect of Adjunctive Oral Methylprednisolone Therapy in Pediatric Urinary Tract Infection
Status: Not yet recruiting Condition: Urinary Tract Infection

Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care
Status: Completed Condition: Cataracts

Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
Status: Completed Condition: Anemia, Hemolytic, Autoimmune

Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive; Chronic Obstructive Pulmonary Disease (COPD)

Can Methylprednisoloneacetate Prevent Seroma After Mastectomy for Primary Breast Cancer
Status: Recruiting Condition: Breast Cancer

Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome
Status: Completed Condition: Ovarian Hyperstimulation Syndrome

Methylprednisolone Replacement for Dexamethasone-induced Hiccup
Status: Withdrawn Condition: Dexamethasone; Hiccup

Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma(MZL)
Status: Completed Condition: B-cell Lymphomas

Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses
Status: Recruiting Condition: Multiple Sclerosis, Relapsing-Remitting

Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse
Status: Recruiting Condition: Multiple Sclerosis

Prednisolone for Pain Reduction in Knee OA
Status: Completed Condition: Pain

Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Secondary Progressive Multiple Sclerosis
Status: Completed Condition: Multiple Sclerosis, Chronic Progressive

Clinical Trial of Vincristine vs. Prednisolone for Treatment of Complicated Hemangiomas
Status: Terminated Condition: Hemangioma

Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection
Status: Recruiting Condition: Corneal Graft Rejection

Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
Status: Completed Condition: Bursitis

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

Oral Prednisolone in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Status: Recruiting Condition: COPD Exacerbation

The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease
Status: Recruiting Condition: Behcet's Disease

Propranolol Versus Prednisolone for Treatment of Symptomatic Hemangiomas
Status: Recruiting Condition: Hemangioma of Infancy

Safety, Pharmacokinetics and Pharmacodynamics Study With 2B3-201 in Healthy Subjects and Multiple Sclerosis(MS) Patients
Status: Terminated Condition: Healthy Volunteers; Multiple Sclerosis

Addition of Pyridoxine to Prednisolone in Infantile Spasms
Status: Recruiting Condition: Infantile Spasms

Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis
Status: Recruiting Condition: Progression of Rheumatoid Arthritis

Durolane Versus Methylprednisolone in Knee Osteoarthritis
Status: Completed Condition: Knee Osteoarthritis

Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache
Status: Completed Condition: Headache

Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
Status: Active, not recruiting Condition: Lymphoproliferative Disorder

Phase 1 PK Interaction Study Between VX-509 and Prednisone or Methylprednisolone in Healthy Male Subjects
Status: Completed Condition: Drug Interactions

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
PRED MILD
prednisolone acetate
SUSPENSION/DROPS;OPHTHALMIC017100-001Approved Prior to Jan 1, 1982RXYes<disabled><disabled>
Alcon
ECONOPRED
prednisolone acetate
SUSPENSION/DROPS;OPHTHALMIC017468-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Schering
METIMYD
prednisolone acetate; sulfacetamide sodium
OINTMENT;OPHTHALMIC010210-002Sep 9, 1984DISCNNo<disabled><disabled>
Akorn
PREDAMIDE
prednisolone acetate; sulfacetamide sodium
SUSPENSION/DROPS;OPHTHALMIC088059-001Jul 29, 1983DISCNNo<disabled><disabled>
Taro
FLO-PRED
prednisolone acetate
SUSPENSION;ORAL022067-002Jan 17, 2008RXYes6,071,523<disabled>Y<disabled>
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International Patent Family for Ingredient: prednisolone acetate

Country Document Number Publication Date
Japan7010743Jan 13, 1995
South Korea20080044245May 20, 2008
European Patent Office0614659Sep 14, 1994
Japan2013014634Jan 24, 2013
Japan2009503097Jan 29, 2009
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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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