VEVYE cyclosporine ophthalmic solution 1 mg/mL Solution/ Drops
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Calcineurin Inhibitor Immunosuppressant class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Cyclosporine levels in your blood can vary quite a bit, and both too much and too little can cause real problems — too high raises the risk of kidney damage, and too low means the...
- Why do I need blood tests so often while taking cyclosporine?
- No — grapefruit and grapefruit juice are a hard no with cyclosporine. They block a key enzyme in your body that normally clears cyclosporine, which can cause your blood levels to c...
- Can I eat grapefruit while taking cyclosporine?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M4M23ZL2AD
A synthetic fluorinated liquid used as a solvent and carrier in some pharmaceutical formulations to help dissolve or disperse active ingredients and improve product stability.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $379.873 | $759.75 / 2 ml |
| Medicaid paysCMS SDUD · 12 mo | $375.41 | $750.83 / 2 ml |
| Medicare drug plans payPart D · Q2 2026 | $367.84 | $735.67 / 2 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vevye 1 mg/mLthis 82667-0900-02 | Harrow | 1 bottle | $379.873 | — | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11413323 ↗ | Method of use | U-3627 | Oct 11, 2039 |
| US 11154513 ↗ | Method of use | U-1900 | Nov 20, 2038 |
| US 12496326 ↗ | Method of use | U-3627 | Sep 29, 2036 |
| US 12059449 ↗ | Method of use | U-1483 | Apr 1, 2042 |
| US 10813976 ↗ | Drug product | — | Sep 22, 2037 |
| US 8614178 ↗ | Drug product | — | Dec 13, 2030 |
| Code | What it grants | Expires |
|---|---|---|
| NP | New Product | May 30, 2026 |
Is there a generic version of VEVYE 0.1% EYE DROP?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 82667-0900-00 | 1 BOTTLE, DROPPER in 1 CARTON (82667-900-00) / 2 mL in 1 BOTTLE, DROPPER | — | — | 2023-12-01 | Active |
| 82667-0900-02 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (82667-900-02) / 2 mL in 1 BOTTLE, DROPPER | $379.87 / mL | $759.75 | 2023-12-01 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 82667-0900-02?
What NDC number is used to bill for this package of VEVYE cyclosporine ophthalmic solution 1 mg/mL Solution/ Drops?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE VEVYE indicated for the treatment of the signs and symptoms of dry eye disease. VEVYE (cyclosporine ophthalmic solution) 0.1% is a calcineurin inhibitor immunosuppressant indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Instill one drop of VEVYE twice a day in each eye approximately 12 hours apart. ( 2 )
2.1Recommended Dosage Instill one drop of VEVYE twice a day in each eye approximately 12 hours apart.
2.2Administration Instructions 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.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 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). Ophthalmic solution containing cyclosporine 0.1%. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Care should be taken to not touch the eye or other surfaces with the bottle tip to avoid potential for eye injury and/or contamination. ( 5.1 )
5.1Potential for Eye Injury and Contamination To avoid the potential for eye injury and/or contamination, patients should not touch the bottle tip to the eye or other surfaces.
5.2Use with Contact Lenses 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reaction following the use of VEVYE were instillation site reactions (8%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience 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%).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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. Data 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).
8.2Lactation 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.
8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
8.5Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy 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. Data 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).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Cyclosporine, a calcineurin inhibitor, is a relatively selective immunomodulatory drug.
12.3Pharmacokinetics 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.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Cyclosporine, a calcineurin inhibitor, is a relatively selective immunomodulatory drug.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/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 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.
📋 Description ▾
11 DESCRIPTION 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 62 H 111 N 11 O 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. Structural Formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Instructions for Use). 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 )] .
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