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SANDIMMUNE

NDA

CYCLOSPORINE | N050625 | NOVARTIS PHARMACEUTICALS CORP

3 strengths0 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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain14 active DMFs5 inactive

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

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

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDCYCLOSPORINE (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

SANDOZ PHARMA LTDInactiveCYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND.

DMF 116181995

GALENA ASInactiveCYCLOSPORINE

DMF 119711996

ZHEJIANG RUIBANG LABORATORIES INCInactiveCYCLOSPORINE

DMF 138581998

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

14 letters from Drugs@FDA

Date	Submission	Document
Mar 9, 2026	SUPPL -65	View Letter (PDF)
Sep 29, 2023	SUPPL -61	View Letter (PDF)
Apr 14, 2022	SUPPL -60	View Letter (PDF)
Apr 2, 2015	SUPPL -55	View Letter (PDF)
May 7, 2013	SUPPL -53	View Letter (PDF)
Sep 5, 2012	SUPPL -49	View Letter (PDF)
May 6, 2010	SUPPL -48	View Letter (PDF)
Nov 10, 2009	SUPPL -47	View Letter (PDF)
Mar 23, 2006	SUPPL -44	View Letter (PDF)
Jul 26, 2005	SUPPL -43	View Letter (PDF)
Jun 17, 2004	SUPPL -30	View Letter (PDF)
Jun 17, 2004	SUPPL -40	View Letter (PDF)
Jun 17, 2004	SUPPL -32	View Letter (PDF)
Feb 27, 2004	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

RLDAB2

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Mar 2, 1990

No patent or exclusivity listings for this strength.

#002 — 100MG

RLDAB2

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 2, 1990

#003 — 50MG

RLDBX

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Nov 23, 1992