VEVYE

Manufacturer: Harrow Eye, LLC
Effective date: 2026-02-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:07:33

Label at a glance#

ProductVEVYE

Active ingredientCYCLOSPORINE

Label structure14 sections

Indications and uses

VEVYE indicated for the treatment of the signs and symptoms of dry eye disease.

Dosage and administration

Instill one drop of VEVYE twice a day in each eye approximately 12 hours apart. Wash hands before using. Gently pull the lower eyelid downward. Tip the bottle upside down over the eye to allow one drop to dispense on its own into the eye. If a drop does not dispense after a few seconds, gently apply slight pressure to the sides of the bottle while holding over the eye. Note: You may not feel the drop falling into ...

Storage and handling

VEVYE is a sterile, clear, colorless non-aqueous ophthalmic solution packaged in multiple-dose eye drop bottles delivering single drops of approximately 0.01 mL volume. Each unit contains 2 mL of VEVYE in a 5 mL transparent squeezable polypropylene bottle with a transparent polyethylene tip and a white polyethylene cap with tamper-evident ring. NDC 82667-900-02 Storage and Handling Do not use if tamper-evident rin...

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

VEVYE indicated for the treatment of the signs and symptoms of dry eye disease.

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

2.1 Recommended Dosage

SPL UNCLASSIFIED SECTION

Instill one drop of VEVYE twice a day in each eye approximately 12 hours apart.

2.2 Administration Instructions

SPL UNCLASSIFIED SECTION

Wash hands before using.

Gently pull the lower eyelid downward. Tip the bottle upside down over the eye to allow one drop to dispense on its own into the eye. If a drop does not dispense after a few seconds, gently apply slight pressure to the sides of the bottle while holding over the eye.

Note:You may not feel the drop falling into your eye.

If VEVYE is used with other eye drops, a 15-minute interval between products should occur.

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Clear, colorless non-preserved ophthalmic solution containing cyclosporine 0.1% (1 mg/mL), delivering 0.01 mg of cyclosporine per one drop (0.01 mL).

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

None.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

5.1 Potential for Eye Injury and Contamination

SPL UNCLASSIFIED SECTION

To avoid the potential for eye injury and/or contamination, patients should not touch the bottle tip to the eye or other surfaces.

5.2 Use with Contact Lenses

SPL UNCLASSIFIED SECTION

VEVYE should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of VEVYE ophthalmic solution.

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

6.1 Clinical Trials Experience

CLINICAL TRIALS EXPERIENCE SECTION

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials with 738 subjects receiving at least 1 dose of VEVYE, the most common adverse reactions were instillation site reactions (8%) and temporary decreases in visual acuity (3%).

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

8.1 Pregnancy

PREGNANCY SECTION

SPL UNCLASSIFIED SECTION

Risk Summary

There are no adequate and well-controlled studies of VEVYE administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses VEVYE doses are approximately 4,700 times lower than recommended oral doses, with blood concentrations being undetectable after topical administration.

SPL UNCLASSIFIED SECTION

Data

SPL UNCLASSIFIED SECTION

Animal Data

Oral administration of cyclosporine oral solution to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body weight) were approximately 7,250 and 48,000 times higher than the daily maximum recommended human ophthalmic dose (MRHOD) of 0.67 mcg/kg/day, respectively.

No adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively (approximately 4,100 and 14,500 times higher than the MRHOD, respectively).

An oral dose of 45 mg/kg/day cyclosporine (approximately 10,900 times higher than MRHOD) administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. No adverse effects in mothers or offspring were observed at oral doses of up to 15 mg/kg/day (3600 times greater than MRHOD).

8.2 Lactation

LACTATION SECTION

SPL UNCLASSIFIED SECTION

Risk Summary

Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. VEVYE doses are approximately 4,700 times lower than recommended oral doses of cyclosporine, with blood concentrations being undetectable after topical administration. However, caution should be exercised when VEVYE is administered to a nursing woman.

8.4 Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

8.5 Geriatric Use

GERIATRIC USE SECTION

No overall difference in safety or effectiveness has been observed between elderly and younger patients.

11 DESCRIPTION

DESCRIPTION SECTION

VEVYE (cyclosporine ophthalmic solution) 0.1% contains the immunomodulatory agent cyclosporine. Cyclosporine's chemical name is Cyclo[[€-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:

Structural Formula

Formula: C ₆₂H ₁₁₁N ₁₁O ₁₂, Molecular weight: 1202.6

Cyclosporine is a white powder that is solubilized in perfluorobutylpentane, a semi-fluorinated alkane vehicle. VEVYE is supplied as a 2 mL sterile, clear, colorless, non-aqueous ophthalmic solution for topical ophthalmic use. VEVYE ^®contains:

Active: cyclosporine 0.1%
Inactives: perfluorobutylpentane, ethanol (anhydrous).

The solution does not contain water or anti-microbial preservatives. As a water free product, there is no associated pH and no osmolarity.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

12.1 Mechanism of Action

MECHANISM OF ACTION SECTION

Cyclosporine, a calcineurin inhibitor, is a relatively selective immunomodulatory drug.

12.3 Pharmacokinetics

PHARMACOKINETICS SECTION

Following bilateral topical ocular dosing of one drop of VEVYE twice daily, the blood concentrations of cyclosporine were below the limit of quantification (0.1 ng/mL) at all timepoints.

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

SPL UNCLASSIFIED SECTION

Carcinogenesis

Evaluation of the potential carcinogenicity of cyclosporine was conducted in male and female mice and rats. In a 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid -dose males significantly exceeded the control value.

In a 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate in the low dose level. The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats were approximately 120 times higher than the maximum recommended human ophthalmic dose (0.67 mcg/kg/day), normalized to body surface area.

SPL UNCLASSIFIED SECTION

Mutagenesis

In genetic toxicity tests, cyclosporine has not been found to be mutagenic/genotoxic in the Ames Test, the V79 HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. Cyclosporine was positive in an in vitro sister chromatid exchange (SCE) assay using human lymphocytes.

SPL UNCLASSIFIED SECTION

Impairment of Fertility

Oral administration of cyclosporine to rats for 12 weeks (male) and 2 weeks (female) prior to mating produced no adverse effects on fertility at doses up to 15 mg/kg/day (approximately 3,600 times higher than the maximum recommended human ophthalmic dose).

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

The safety and efficacy of VEVYE were assessed in a total of 1369 patients with dry eye disease, of which 738 received VEVYE.

In two multicenter, randomized, adequate and well-controlled clinical studies, patients with dry eye disease (CYS-002: NCT02617667 and CYS-004: NCT04523129), treated with VEVYE ^®were compared to patients treated with vehicle. At Day 29, there was a statistically significant higher percentage of eyes with increases of ≥ 10 mm from baseline in Schirmer wetting. This effect was seen in approximately 10% of VEVYE-treated patients versus approximately 6% of vehicle-treated patients.

Percent of Patients Achieving ≥ 10 mm Improvement from Baseline in Schirmer's Tear Test Score in Study Eyes in Patients with Dry Eye Disease
	CYS-002 Day 29		CYS-004 Day 29
	VEVYE N=51	Vehicle N=51	VEVYE N=409	Vehicle N=395
≥ 10 mm increase in tear production (% patients)	8%	0%	11%	7%
Difference (95% CI)	7.8% (0.5%, 15.%)		3.9% (0.02%, 7.8%)
p-value versus vehicle	0.04		0.05

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

NDC 82667-900-02

SPL UNCLASSIFIED SECTION

Storage and Handling

Do not use if tamper-evident ring attached to the white cap is not intact. After first opening the tamper-evident ring of the cap remains on the bottle neck. Retain the cap and keep the bottle tightly closed when not in use.

Store at 15°C to 25°C (59°F to 77°F). Do not freeze or refrigerate. After opening, VEVYE can be used until the expiration date on the bottle.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise patients to read the FDA-approved patient labeling (Instructions for Use).

SPL UNCLASSIFIED SECTION

Risk of Contamination

Advise patients to wash their hands well before each use. Advise patients not to allow the dropper tip to touch the eye or any other surface, as this may contaminate the solution [see Warning and Precautions ( 5.1)] .

SPL UNCLASSIFIED SECTION

Contact Lens Wear

Contact lenses should be removed prior to instillation of VEVYE and may be reinserted 15 minutes following administration [see Warning and Precautions ( 5.2)] .

HARROW^®
Distributed by
Harrow Eye, LLC
Nashville, TN 37215
USA
© 2024

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 2 mL Carton Label

NDC: 82667-900-02 Rx Only

vevye ^®

(cyclosporine ophthalmic
soliton) 0.1%

For topical application
In the eye

Sterile, Non-Preserved

2 mL

Principal Display Panel - 2 mL Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2639936	cycloSPORINE 0.1 % Ophthalmic Solution	PSN	4
2639941	vevye 0.1 % Ophthalmic Solution	PSN	4
2639941	cyclosporine 1 MG/ML Ophthalmic Solution [Vevye]	SBD	4
2639936	cyclosporine 1 MG/ML Ophthalmic Solution	SCD	4
2639936	cyclosporine 0.1 % Ophthalmic Solution	SY	4
2639941	Vevye 0.1 % Ophthalmic Solution	SY	4
2639941	Vevye 1 MG/ML Ophthalmic Solution	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CYCLOSPORINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1be408a0-e15a-4092-b35e-4e294e65196f	Product name	3	20240216
b3fdee3e-0c46-442f-aad5-aa71941d5621	Product name	1	20231023
78fb0708-fce5-decd-6611-5a9fbe3e3dec	Product name	3	20230327
54840517-000d-4fcb-b976-a6ddd102faa0	Product name	1	20220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633a	Product name	1	20181029
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
b1c0d609-8b97-06ee-2cd0-5652a4b1d019	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82667-900-00	2024-01-30	C162847	48780-1	1030e365-280f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
82667-900-00	2024-01-30	C162847	48780-1	1030e365-280f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
82667-900-00	2024-01-30	C162847	48780-1	1030e365-280f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
82667-900-02	2024-01-30	C162847	48780-1	1030e365-280f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
82667-900-02	2024-01-30	C162847	48780-1	1030e365-280f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
82667-900-02	2024-01-30	C162847	48780-1	1030e365-280f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82667-900-00	VEVYE	2 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2	4
82667-900-00	VEVYE	1 in 1 CARTON	SOLUTION/ DROPS	1	4
82667-900-02	VEVYE	1 in 1 CARTON	SOLUTION/ DROPS	1	4
82667-900-02	VEVYE	2 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	2	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82667-900-02	ML - Milliliter	82667-900	5721caa8-a8d9-47d5-a448-bd6658e2f3de	1	2024-01-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

VEVYE
cyclosporine ophthalmic solution
1,1,1,2,2,3,3,4,4-NONAFLUORONONANE
ALCOHOL
CYCLOSPORINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
82667-900	82667-900-02, 82667-900-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
1,1,1,2,2,3,3,4,4-NONAFLUORONONANE	M4M23ZL2AD	IACT
ALCOHOL	3K9958V90M	IACT
CYCLOSPORINE	83HN0GTJ6D	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2025-11-14	monthly-update	2026-06-03 17:43:45
1	2023-11-21	full-release	2026-05-31 20:55:48

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217469-001	VEVYE	CYCLOSPORINE	0.1%	SOLUTION / OPHTHALMIC		RLD, RS	2023-05-30

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217469-001	8614178	2030-12-13		Drug product	2023-06-22
N217469-001	12496326	2036-09-29	U-3627		2025-12-17
N217469-001	10813976	2037-09-22		Drug product	2023-06-22
N217469-001	11413323	2039-10-11	U-3627		2023-06-22
N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217469-001	NP	2026-05-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217469-001	VEVYE	0.1%	SOLUTION / OPHTHALMIC	RLD, RS	2023-05-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 107 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217469-001	12496326	2036-09-29	U-3627		2025-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217469-001	12496326	2036-09-29	U-3627		2025-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217469-001	12496326	2036-09-29	U-3627		2025-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	11413323	2039-10-11	U-3627		2023-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	12059449	2042-04-01	U-1483	Drug product	2024-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	8614178	2030-12-13		Drug product	2023-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	10813976	2037-09-22		Drug product	2023-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	11154513	2038-11-20	U-1900	Drug product	2023-06-22	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N217469-001	NP	2026-05-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217469-001	NP	2026-05-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217469-001	NP	2026-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217469-001	NP	2026-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217469-001	NP	2026-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217469-001	NP	2026-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217469-001	NP	2026-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217469-001	NP	2026-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217469-001	NP	2026-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217469-001	NP	2026-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217469-001	NP	2026-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217469-001	NP	2026-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217469-001	NP	2026-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217469-001	NP	2026-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217469-001	NP	2026-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217469-001	NP	2026-05-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217469-001	NP	2026-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217469-001	NP	2026-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217469-001	NP	2026-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217469-001	NP	2026-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217469-001	NP	2026-05-30	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217469-001	NP	2026-05-30	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VEVYE	CYCLOSPORINE OPHTHALMIC SOLUTION	Harrow Eye, LLC	0a60fccf-7e1b-44fe-e063-6394a90aadd5	2026-02-26	Warnings, Adverse reactions	Exact identifier ndc (package): 82667-900-00 ndc (package): 82667-900-02 ndc (product): 82667-900 ndc11 (package): 82667090002 ndc11 (package): 82667090000 spl id: 4bc25aeb-44ca-06b2-e063-6294a90a03c0 spl set id: 0a60fccf-7e1b-44fe-e063-6394a90aadd5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.