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VEVYE

NDA

CYCLOSPORINE | N217469 | HARROW EYE LLC

1 strength6 unique patents1 unique exclusivity

Patent Timeline

6 unique patents, 1 exclusivity by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

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2039

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2041

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2043

Today

Dec. 13, 2030

Sep. 22, 2037

Nov. 20, 2038

Oct. 11, 2039

Apr. 1, 2042

Sep. 29, 2036

May. 30, 2026

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Triple Gate Capital, LP FDA-2025-P-5831 · 3 docket documents Triple Gate Capital, LP filed this citizen petition under 21 CFR §10.30 requesting that the FDA rescind approval of VEVYE (cyclosporine ophthalmic solution) 0.1% under NDA 217469, arguing that the approval violated CFR §314.25(b)(5) because none of the clinical trials demonstrated substantial eviden	Other	2025-11-04	Open	Triple Gate Capital, LP

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.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$379.87

per ml

Lowest NADAC/Unit

$379.87

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82667090002VEVYE 0.1% EYE DROP	$379.87	ML	Brand	—	2026-07-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$576.05

Highest Price

$576.05

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82667-0900-02VEVYE 0.1% (PF) SOLN,OPH,2ML	$576.05	FSS	Harrow Eye, LLC	03/14/2029

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

Medicare Part D Spending

CMS annual spending data for Vevye (2024)

Total Spending

$13.2M

Total Claims

15,393

Beneficiaries

5,877

Avg Cost/Unit

$366.30

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

3 letters from Drugs@FDA

Date	Submission	Document
Sep 19, 2025	SUPPL -7	View Letter (PDF)
May 29, 2024	SUPPL -3	View Letter (PDF)
May 31, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

RLD

6 patents1 exclusivity▴

SOLUTION;OPHTHALMIC | Approved: May 30, 2023

Patents (6) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8614178	Dec 13, 2030	—	—	Yes	—	—
10813976	Sep 22, 2037	—	—	Yes	—	—
11154513	Nov 20, 2038	—	—	Yes		—
11413323	Oct 11, 2039	—	—	—		—
12059449	Apr 1, 2042	—	—	Yes		—
12496326	Sep 29, 2036	—	—	—		—

Exclusivities (1)

Code	Date	Status
NP	May 30, 2026	Expired