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CYCLOSPORINE

ANDA

CYCLOSPORINE | A211909 | AMNEAL PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: RESTASIS(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Allergan, Inc. et al v. Amneal Pharmaceuticals LLC et al 1:2018cv01457 2 patentsANDA 211909Cyclosporine Ophthalmic Emulsion, 0.05%	D. Del.	2018-09-20	Terminated 2019-01-03	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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.

Products (1)

#001 — 0.05%

0 patents0 exclusivities▴

EMULSION;OPHTHALMIC | Approved: Nov 28, 2025

No patent or exclusivity listings for this strength.