Viewing data from:

NEORAL

NDA

CYCLOSPORINE | N050716 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

395 trials from ClinicalTrials.gov — 8 recruiting, 4 active, 275 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders NCT00544115	Phase 2	Active	City of Hope Medical Center	260	2001-10-16 → 2027-03-29
Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita NCT01659606	Phase 2	Active	Boston Children's Hospital	40	2012-07 → 2034-12
Eltrombopag With Standard Immunosuppression for Severe Aplastic Anemia NCT01623167	Phase 1/2	Active	National Heart, Lung, and Blood Institute (NHLBI)	207	2012-07-02 → 2029-11-30
Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.NCT02936505	N/A	Active	Vastra Gotaland Region	249	2016-10-12 → 2026-10-30
Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR NCT02416388	Phase 2/3	Recruiting	University Hospital, Angers	3,100	2015-01 → 2032-01
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy NCT00977977	Phase 2	Recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	30	2010-12-22 → 2027-12-31
Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome NCT01624805	Phase 2	Recruiting	M.D. Anderson Cancer Center	140	2012-06-25 → 2029-06-30
Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA)NCT04304820	Phase 2	Recruiting	National Heart, Lung, and Blood Institute (NHLBI)	80	2020-05-07 → 2033-12-18
211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia NCT03128034	Phase 1/2	Recruiting	Fred Hutchinson Cancer Center	75	2017-10-24 → 2029-03-31
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)NCT03970096	Phase 2	Recruiting	Fred Hutchinson Cancer Center	120	2019-11-19 → 2029-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$419.80

Highest Price

$436.28

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0274-22NEORAL 100MG/ML ORAL SOLN	$436.28	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0274-22NEORAL 100MG/ML ORAL SOLN	$419.80	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain15 active DMFs7 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

CKD BIO CORPCYCLOSPORINE, NON-STERILE BULK, USP

DMF 122141996

TAPI NL BVCYCLOSPORINE

DMF 129321998

CURIA ITALY SRLCYCLOSPORINE

DMF 129491998

FUJIAN KERUI PHARMACEUTICAL CO LTDCYCLOSPORINE

DMF 137891998

TAPI NL BVCYCLOSPORINE

DMF 137991998

ABBVIE INCCYCLOSPORINE USP

DMF 138001998

APOTEX INCCYCLOSPORINE USP (BULK)

DMF 139291999

JOYANG LABORATORIESCYCLOSPORINE (NON-STERILE BULK FORM)

DMF 189322005

CONCORD BIOTECH LTDCYCLOSPORINE USP

DMF 239622010

ZHEJIANG RUIBANG LABORATORIESCYCLOSPORINE

DMF 285122014

TAPI NL BVCYCLOSPORINE ID: 741710

DMF 295572015

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDCYCLOSPORINE USP, NON-STERILE BULK DRUG SUBSTANCE

DMF 339462019

TAPI NL BVCYCLOSPORINE ID: 741310

DMF 346422020

CURIA ITALY SRLCYCLOSPORINE 350507

DMF 363852021

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)CYCLOSPORINE USP

DMF 429662025

NORTH CHINA PHARMACEUTICAL CORPInactiveCYCLOSPORINE, USP (BULK, NON-STERILE)

DMF 102811993

SANDOZ PHARMA LTDInactiveCYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND.

DMF 116181995

GALENA ASInactiveCYCLOSPORINE

DMF 119711996

ZHEJIANG RUIBANG LABORATORIES INCInactiveCYCLOSPORINE

DMF 138581998

NORTH CHINA PHARMACEUTICAL CORPInactiveCYCLOSPORINE, USP (NON STERILE BULK)

DMF 143151998

WATSON LABORATORIES INCInactiveCYCLOSPORINE

DMF 153282001

ZHEJIANG RUIBANG LABORATORIESInactiveCYCLOSPORINE CRUDE

DMF 314652018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Sep 27, 2023	SUPPL -41	View Letter (PDF)
Apr 2, 2015	SUPPL -38	View Letter (PDF)
May 7, 2013	SUPPL -34	View Letter (PDF)
Sep 5, 2012	SUPPL -30	View Letter (PDF)
Nov 12, 2009	SUPPL -28	View Letter (PDF)
Nov 9, 2009	SUPPL -29	View Letter (PDF)
Aug 2, 2007	SUPPL -26	View Letter (PDF)
Mar 23, 2006	SUPPL -25	View Letter (PDF)
Jul 26, 2005	SUPPL -24	View Letter (PDF)
Feb 27, 2004	SUPPL -20	View Letter (PDF)
Feb 27, 2004	SUPPL -21	View Letter (PDF)
Jun 12, 2002	SUPPL -14	View Letter (PDF)
Jun 12, 2002	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/ML

RLDAB1

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jul 14, 1995

No patent or exclusivity listings for this strength.