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Details for Generic Name: cyclosporine

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Cyclosporine is the generic ingredient in five branded drugs marketed by Apotex, Ivax Sub Teva Pharms, Sandoz, Watson Labs Inc, Abbvie, Novartis, Allergan, Eurohlth Intl, Luitpold, Apotex Inc, Watson Labs, and Wockhardt, and is included in eighteen NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for cyclosporine. Four suppliers are listed for this compound.

Summary for Generic Name: cyclosporine

Tradenames:5
Patents:7
Applicants:12
NDAs:18
Drug Master File Entries: see list15
Suppliers: see list4
Therapeutic Class:Immunological Agents
Ophthalmic Agents

Clinical Trials for: cyclosporine

A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients
Status: Completed Condition: Liver Transplantation

Low Dose Cyclosporin A in Primary Sjögren Syndrome
Status: Active, not recruiting Condition: Sjögren´s Syndrome

Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids
Status: Completed Condition: Kidney Transplantation

To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris
Status: Completed Condition: Psoriasis

Drug Interaction Study of Isavuconazole and Cyclosporine
Status: Completed Condition: Healthy

Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
Status: Completed Condition: Dry Eye Syndromes

Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients
Status: Completed Condition: End Stage Renal Failure

PK, Safety & Tolerability of CyCol® Versus Sandimmune® in Healthy Subjects
Status: Active, not recruiting Condition: Healthy

Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Classic Paroxysmal Nocturnal Hemoglobinuria
Status: Active, not recruiting Condition: Paroxysmal Nocturnal Hemoglobinuria; Hemoglobinuria; Hemoglobinuria, Paroxysmal; Proteinuria; Urination Disorders; Thrombosis; Bone Marrow Failure; Aplastic Anemia,; Anemia, Hemolytic

Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis
Status: Completed Condition: Atopic Keratoconjunctivitis

Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013)
Status: Active, not recruiting Condition: Paroxysmal Nocturnal Hemoglobinuria; Hemoglobinuria; Hemoglobinuria, Paroxysmal; Proteinuria; Urination Disorders; Thrombosis; Bone Marrow Failure; Aplastic Anemia,; Anemia, Hemolytic

Dasatinib and Cyclosporine in Treating Patients With Chronic Myelogenous Leukemia Refractory or Intolerant to Imatinib Mesylate
Status: Terminated Condition: Accelerated Phase Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Phase Chronic Myelogenous Leukemia; Relapsing Chronic Myelogenous Leukemia

Prevention of Ocular Graft-Versus Host Disease With Topical Cyclosporine in Recipients of Allogeneic Hematopoietic Stem Cell Transplants Performed With a Reduced Intensity Conditioning Regimen
Status: Recruiting Condition: Ocular Graft Versus Host Disease

Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel
Status: Withdrawn Condition: Epiphora

The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes
Status: Not yet recruiting Condition: Type 1 Diabetes

Comparisone of Iminoral Versus Neoral in Prevention of Acute Rejection in Renal Transplantation
Status: Completed Condition: End Stage Renal Disease; Renal Transplantation

Switch From Tacrolimus to Cyclosporin in the Treatment of Recurrent Hepatitis C After Liver Transplantation
Status: Terminated Condition: Chronic Hepatitis C; Evidence of Liver Transplantation

Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group
Status: Recruiting Condition: Dry Eye Syndromes

Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia
Status: Completed Condition: Large Granular Lymphocytic Leukemia; LGL Leukemia

Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
Status: Recruiting Condition: Renal Transplantation

Cyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer
Status: Completed Condition: Metastatic Breast Cancer

Antithymocyte Globulin and Cyclosporine to Treat Myelodysplasia
Status: Completed Condition: Myelodysplastic Syndrome

Bioequivalence Study of Cyclosporine 100mg Capsule Under Fed Condition
Status: Completed Condition: Healthy Volunteers

Bioequivalence Study of Cyclosporine 100mg Capsule Under Fasting Condition
Status: Completed Condition: Healthy Volunteers

Drug-Drug Interaction Study Between Colchicine and Cyclosporine
Status: Completed Condition: Pharmacokinetics; Healthy

Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis
Status: Completed Condition: Chronic Plaque Psoriasis

The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients
Status: Not yet recruiting Condition: Type 1 Diabetes

Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer
Status: Recruiting Condition: Adult Solid Neoplasm; Recurrent Colon Carcinoma; Recurrent Rectal Carcinoma; Stage IIIA Colon Cancer; Stage IIIA Rectal Cancer; Stage IIIB Colon Cancer; Stage IIIB Rectal Cancer; Stage IIIC Colon Cancer; Stage IIIC Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer

Diabetogenicity of Cyclosporine and Tacrolimus
Status: Completed Condition: Complications of Transplanted Organs and Tissue; Diabetes Mellitus Nos New Onset

Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic Anemia
Status: Completed Condition: Aplastic Anemia

Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation
Status: Completed Condition: Bronchiolitis Obliterans; Immunosuppression

Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
Status: Completed Condition: Transplantation Infection

Comparison of Effect of Postoperative Cyclosporine A 2% Ophthalmic Emulsion and Betamethasone Eye Drop on Surgical Success of Trabeculectomy Procedure
Status: Active, not recruiting Condition: Glaucoma, Open Angle

Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action
Status: Recruiting Condition: Interstitial Cystitis

NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye
Status: Completed Condition: Dry Eye

Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients
Status: Active, not recruiting Condition: ST Elevation Acute Myocardial Infarction

Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome
Status: Completed Condition: Myelodysplastic Syndrome; Aplastic Anemia

Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
Status: Terminated Condition: Lymphoma

Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
Status: Terminated Condition: Cardiac Surgical Procedures

Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
Status: Completed Condition: Organ Transplantation, Renal Transplantation

A Phase I Open-Label Study of the Effects of Tacrolimus and Cyclosporine on CP-690,555 in Healthy Volunteers
Status: Completed Condition: Healthy Volunteers

Oral Cyclosporine in Chronic Obstructive Pulmonary Disease
Status: Active, not recruiting Condition: Chronic Obstructive Pulmonary Disease

Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Status: Terminated Condition: Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia

Comparison of Extended Release Tacrolimus (Advagraf) and Cyclosporine A Microemulsion on Renal Function in Healthy Volunteers
Status: Completed Condition: Healthy

A Controlled Study of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy
Status: Recruiting Condition: Idiopathic Membranous Nephropathy; Proteinuria; Spontaneous Remission; Steroid Nephropathy; Cyclosporin Overdose

Lotemax® Gel 0.5% and Restasis 0.05% in Subjects With Mild or Moderate Keratoconjunctivitis Sicca
Status: Completed Condition: Keratoconjunctivitis Sicca

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

Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis
Status: Recruiting Condition: Vernal Keratoconjunctivitis

Renal Function Evaluation After Reduction of Cyclosporine A Dose in Renal Transplant Patients
Status: Completed Condition: Kidney Transplantation; Primary Prevention; Kidney Failure

Ciclosporin in the Management of New Erythema Nodosum Leprosum
Status: Not yet recruiting Condition: Leprosy

Ciclosporin in the Management of New Type 1 Reactions in Leprosy
Status: Not yet recruiting Condition: Leprosy

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

Copenhagen Head Injury Ciclosporin (CHIC) Study
Status: Recruiting Condition: Traumatic Brain Injury

Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study
Status: Completed Condition: Systemic Lupus Erythematosus; Lupus Nephritis

Cyclosporine A in Cardiac Arrest
Status: Completed Condition: Non Shockable Out of Hospital Cardiac Arrest

Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation
Status: Completed Condition: Heart Transplantation

Ciclosporin in the Management of Chronic or Recurrent Erythema Nodosum Leprosum
Status: Not yet recruiting Condition: Leprosy

Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Status: Completed Condition: Liver Transplantation; Infection

Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation
Status: Completed Condition: Heart Transplantation

Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis
Status: Completed Condition: Vernal Keratoconjunctivitis

The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface
Status: Recruiting Condition: Dry Eye

Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Status: Terminated Condition: Liver Transplant; Hepatitis C

Low Dose Cyclosporin and Methotrexate Therapy in Diabetes
Status: Completed Condition: Type 1 Diabetes Mellitus

Metabolic Pattern of Cyclosporine A and Acute Renal Failure
Status: Completed Condition: Heart Transplantation; Acute Renal Failure

A Study in Healthy Participants Investigating the Effect of TMC435 on the Pharmacokinetics of Immunosuppressants Cyclosporine and Tacrolimus
Status: Completed Condition: Hepatitis C Virus

A Study to Compare the Bioavailability and Pharmacokinetics of Cyclosporine After Intravenous Administration of NEUROSTAT®, a CREMOPHOR® EL-free Lipid Emulsion, and SANDIMMUNE® Injection (a Suspension of Cyclosporine in CREMOPHOR® EL) in Healthy Volunteers
Status: Completed Condition: Healthy

Study of Cyclosporine in Post-LASIK Patients
Status: Completed Condition: Laser In Situ Keratomileusis

Aerosol Cyclosporine in Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: Chronic Obstructive Pulmonary Disease

Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
Status: Completed Condition: Stevens-Johnson Syndrome

Total-Body Irradiation Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Severe Combined Immunodeficiency Undergoing Donor Bone Marrow Transplant
Status: Active, not recruiting Condition: Immune System Disorder; Severe Combined Immunodeficiency

Drug-Drug Interaction Study With Pravastatin and Cyclosporine
Status: Active, not recruiting Condition: Healthy

A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers
Status: Completed Condition: Healthy Volunteer

Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients
Status: Completed Condition: Liver Transplant

Horse ATG in Patients With AA or Low/Int-1 Risk MDS
Status: Recruiting Condition: Leukemia

CYCLosporinE A in Reperfused Acute Myocardial Infarction
Status: Active, not recruiting Condition: Acute Myocardial Infarction

Study to Assess Effect of Cyclosporine on the Blood Levels of Ticagrelor
Status: Completed Condition: Healthy

Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
Status: Completed Condition: Hepatitis C

Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery?
Status: Completed Condition: Glaucoma

Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis
Status: Completed Condition: Ulcerative Colitis; Steroid Refractory

Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.
Status: Completed Condition: Renal Transplantation

Drug Interaction Between Colchicine and Calcineurin Inhibitors in Renal Graft Recipients
Status: Completed Condition: Renal Replacement Therapies

Restasis for Treatment of Brittle Nails
Status: Completed Condition: Brittle Nails

Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
Status: Completed Condition: Kidney Transplantation

Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer
Status: Completed Condition: Colorectal Cancer

Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)
Status: Completed Condition: Keratoconjunctivitis, Vernal

Drug-drug Interaction Study of Eltrombopag and Cyclosporine in Healthy Subjects
Status: Not yet recruiting Condition: Purpura, Thrombocytopenic, Idiopathic

Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients
Status: Completed Condition: Kidney Transplant

Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.
Status: Completed Condition: de Novo Kidney Transplant Recipients; Renal Transplantation

Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients
Status: Completed Condition: Renal Transplantation

Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
Status: Completed Condition: Moderate to Severe Dry Eye Syndrome

Evaluation of Blink Tears and Systane Concomitant With Restasis for the Treatment of Dry Eye Symptoms
Status: Completed Condition: Dry Eye Syndrome

Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers
Status: Completed Condition: Contact Lens Wearers With Dry Eye Syndrome

Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients
Status: Recruiting Condition: Disorder Related to Lung Transplantation; Bronchiolitis Obliterans; Decreased Immunologic Activity; Chronic Rejection of Lung Transplant

Study of Tisporin Eye Drops Group and Restasis Eye Drops Group After Treatment, Each Treatment Group Comparisons for Evaluation of Efficacy and Safety in Moderate to Severe Dry Eye Disease
Status: Completed Condition: Dry Eye Syndromes

Tacrolimus/Sirolimus/Methotrexate Versus Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma
Status: Active, not recruiting Condition: Non-hodgkin Lymphoma; Hodgkin Lymphoma

Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus
Status: Active, not recruiting Condition: Dry Eye Syndromes; HIV Seropositivity

A Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)
Status: Recruiting Condition: Immune Thrombocytopenia

Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda
Status: Completed Condition: Vernal Keratoconjunctivitis

Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
Status: Recruiting Condition: Primary Sjogren Syndrome; Secondary Sjogren Syndrome; Aqueous Deficient Dry Eye Disease; Evaporative Dry Eye Disease

MD Ezetimibe Cyclosporine Interaction (0653-057)
Status: Completed Condition: Cholesterol

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
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715Jul 14, 1995RXYes5,985,321<disabled>Y<disabled>
Novartis
SANDIMMUNE
cyclosporine
CAPSULE;ORAL050625Nov 23, 1992RXNo<disabled><disabled>
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715Jul 14, 1995DISCNNo5,985,321<disabled>Y<disabled>
Watson Labs
CYCLOSPORINE
cyclosporine
SOLUTION;ORAL065054Dec 18, 2001RXNo<disabled><disabled>
Novartis
NEORAL
cyclosporine
CAPSULE;ORAL050715Jul 14, 1995RXNo5,985,321<disabled>Y<disabled>
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