Viewing data from:

VERKAZIA

NDA

CYCLOSPORINE | N214965 | HARROW EYE LLC

1 strength7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents, 1 exclusivity by expiration date

Expired (5)Active (2)TodayExclusivity

2026

2027

2028

2029

Today

Jan. 27, 2026

Nov. 3, 2027

Jan. 27, 2026

Jun. 2, 2029

Jan. 27, 2026

Jan. 27, 2026

Jan. 27, 2026

ODE-358

Jun. 23, 2028

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

Medicare Part D Spending

CMS annual spending data for Verkazia (2023)

Total Spending

$283K

Total Claims

162

Beneficiaries

Avg Cost/Unit

$12.94

Spending Trend

$114K(2022)→$283K(2023)

YoY Change:+1.8%

5yr CAGR:+1.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

1 letter from Drugs@FDA

Date	Submission	Document
Jun 24, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLD

7 patents1 exclusivity▴

EMULSION;OPHTHALMIC | Approved: Jun 23, 2021

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7973081	Jan 27, 2026	—	—	Yes	—	—
8298568	Nov 3, 2027	—	—	Yes	—	—
8524779	Jan 27, 2026	—	—	Yes	—	—
9132071	Jun 2, 2029	—	—	Yes	—	—
9220694	Jan 27, 2026	—	—	Yes	—	—
9956289	Jan 27, 2026	—	—	Yes	—	—
11612658	Jan 27, 2026	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-358	Jun 23, 2028	Active