Viewing data from:

SANDIMMUNE

NDA

CYCLOSPORINE | N050574 | 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

6 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Felix Pharmaceuticals Pvt. Ltd FDA-2026-P-2004 · 6 docket documents Felix Pharmaceuticals Pvt. Ltd. filed this petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting permission to submit an abbreviated new animal drug application (ANADA) for a generic cyclosporine oral solution for dogs that differs in dosage form from the pioneer pro	Suitability	2026-02-25	Open	Felix Pharmaceuticals Pvt. Ltd
Suitability Petition from Mizner Bioscience, LLC FDA-2023-P-0101 · 6 docket documents Mizner Bioscience, LLC filed a suitability petition under section 512(n)(3) of the Federal Food, Drug and Cosmetic Act requesting permission to file an Abbreviated New Animal Drug Application (ANADA) for a generic cyclosporine oral solution for dogs with atopic dermatitis. The proposed product diffe	Suitability	2023-01-10	Granted	Mizner Bioscience, LLC
Suitability Petition from Ceva Animal Health, LLC FDA-2017-P-6968 · 5 docket documents Ceva Animal Health, LLC filed this suitability petition on December 21, 2017 under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA determine an ANADA filing is suitable for a generic cyclosporine oral solution for dogs that differs in dosage form from the refer	Suitability	2017-12-22	Granted	Ceva Animal Health, LLC
Citizen Petition from Physical Pharmaceutica, LLC FDA-2015-P-1404 · 4 docket documents Physical Pharmaceutica LLC filed this citizen petition in April 2015 regarding the approval of Abbreviated New Drug Applications (ANDAs) referencing RESTASIS 0.05% ophthalmic emulsion as the reference listed drug. Physical Pharmaceutica requests that the FDA provide detailed guidance on what compara	505(q)	2015-04-30	Partially Denied	Physical Pharmaceutica, LLC
Citizen Petition From Allergan, Inc. FDA-2015-P-0065 · 25 docket documents Allergan, Inc. filed this citizen petition on December 23, 2014, requesting that FDA refuse to receive for substantive review or approve any abbreviated new drug application referencing RESTASIS (cyclosporine ophthalmic emulsion) unless it includes data from comparative clinical trials demonstrating	505(q)	2015-01-16	Partially Denied	Allergan, Inc.
Shotwell & Carr, Inc. - Citizen Petition FDA-2013-P-0426 · 3 docket documents Shotwell & Carr, Inc. filed a petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine a new dosage form of cyclosporine oral solution for dogs (Cyclosporine 100 mg/mL Oral Solution) is suitable for submission as an abbreviated new animal drug ap	Other	2013-05-08	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

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
Mar 9, 2026	SUPPL -60	View Letter (PDF)
Sep 29, 2023	SUPPL -57	View Letter (PDF)
Apr 2, 2015	SUPPL -51	View Letter (PDF)
May 7, 2013	SUPPL -47	View Letter (PDF)
Sep 5, 2012	SUPPL -43	View Letter (PDF)
May 6, 2010	SUPPL -42	View Letter (PDF)
Nov 10, 2009	SUPPL -41	View Letter (PDF)
Mar 23, 2006	SUPPL -40	View Letter (PDF)
Jul 26, 2005	SUPPL -39	View Letter (PDF)
Jun 17, 2004	SUPPL -29	View Letter (PDF)
Jun 17, 2004	SUPPL -27	View Letter (PDF)
Feb 27, 2004	SUPPL -37	View Letter (PDF)
Feb 27, 2004	SUPPL -35	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Nov 14, 1983

No patent or exclusivity listings for this strength.