Tyrvaya varenicline .03 mg/.05mL Spray, 2 bottles
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Partial Cholinergic Nicotinic Agonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Varenicline nasal spray is used to treat the signs and symptoms of dry eye disease (an eye disorder in which tears do not provide sufficient eye lubrication). Varenicline is in a class of medications called cholinergic agonists. It works by activating nerve endings in your nose resulting in increased production of tears in the eyes.
Read the full MedlinePlus article ↗- Tyrvaya is a prescription nasal spray used to treat the signs and symptoms of dry eye disease. It works by stimulating nerve pathways through the nose that help your eyes produce t...
- That's a great question! Tyrvaya works by activating nerve receptors in the nasal passages that are connected to the tear glands. Spraying it in the nose triggers those nerves to s...
- Why does this eye medicine go in my nose instead of my eye?
- Very likely, yes — sneezing was reported by about 82% of patients in the clinical trials. It's the most common reaction and happens because of how the spray activates nerves in the...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Varenicline — tap one for details:
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.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 70WT22SF4B
A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
-
UNII KH7I04HPUU
A salt compound made from sodium and phosphoric acid, used as a buffer to help maintain a stable pH level in the medicine, and sometimes as a binder or filler in tablets and capsules.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 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 | $79.600 | $668.64 / 8.4 ml |
| Medicaid paysCMS SDUD · 12 mo | $79.37 | $666.67 / 8.4 ml |
| Medicare drug plans payPart D · Q2 2026 | $84.67 | $711.21 / 8.4 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tyrvaya .03 mg/.05mLthis 73521-0030-02 | Oyster | 2 bottles | $79.600 | — | 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 11224598 ↗ | Method of use | U-1900 | Oct 19, 2035 |
| US 10456396 ↗ | Method of use | U-1900 | Oct 19, 2035 |
| US 9597284 ↗ | Method of use | U-1900 | Oct 19, 2035 |
| US 9532944 ↗ | Method of use | U-1900 | Oct 19, 2035 |
| US 9504644 ↗ | Method of use | U-1900 | Oct 19, 2035 |
| US 11911380 ↗ | Method of use | U-1900 | Oct 19, 2035 |
| US 11903943 ↗ | Method of use | U-1900 | Oct 19, 2035 |
| US 11903941 ↗ | Method of use | U-1900 | Oct 19, 2035 |
| US 12576080 ↗ | Method of use | U-1900 | Oct 19, 2035 |
| US 12653824 ↗ | Drug product | — | Oct 19, 2035 |
| US 9504645 ↗ | Drug product | — | Oct 19, 2035 |
| US 11903942 ↗ | Drug product | — | Oct 19, 2035 |
Is there a generic version of TYRVAYA 0.03 MG NASAL SPRAY?
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)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 73521-0030-02 You're viewing this | 2 BOTTLE, PUMP in 1 CARTON (73521-030-02) / 4.2 mL in 1 BOTTLE, PUMP | $79.60 / mL | $668.64 | 2021-10-20 | Active |
| 73521-0030-90 | 1 BOTTLE, PUMP in 1 CARTON (73521-030-90) / 4.2 mL in 1 BOTTLE, PUMP | — | — | 2021-10-20 | 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 73521-0030-02?
What is the difference between NDC 73521-0030-02 and NDC 73521-0030-90?
What NDC number is used to bill for this package of Tyrvaya varenicline .03 mg/.05mL Spray?
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 TYRVAYA (varenicline solution) nasal spray is indicated for the treatment of the signs and symptoms of dry eye disease. TYRVAYA (varenicline solution) nasal spray is a cholinergic agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • One spray in each nostril twice daily (approximately 12 hours apart). ( 2.1 ) • Prime with seven (7) actuations before initial use. Re-prime with 1 actuation if not used for more than five (5) days. ( 2.2 )
2.1Dosing Information Spray TYRVAYA once in each nostril twice daily (approximately 12 hours apart). If a dose is missed, resume regular dosing at the next scheduled dose time.
2.2Priming Instructions Priming: Prime TYRVAYA before initial use by pumping seven (7) actuations into the air away from the face. When TYRVAYA has not been used for more than 5 days, re-prime with 1 spray into the air. Do not shake.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Nasal spray delivering 0.03 mg of varenicline in each spray (0.05 mL). Nasal spray delivering 0.03 mg of varenicline in each spray (0.05 mL). ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None None.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5-16% of patients were cough, throat irritation, and instillation-site (nose) irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oyster Point Pharma, Inc. at 1-877-EYE-0123 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 three clinical studies of dry eye disease conducted with varenicline solution nasal spray, 349 patients received at least 1 dose of TYRVAYA. The majority of patients had 31 days of treatment exposure, with a maximum exposure of 105 days.
The most common adverse reactions reported in 82% of TYRVAYA treated patients was sneezing. Other common adverse reactions that were reported in >5% of patients include cough (16%), throat irritation (13%), and instillation-site (nose) irritation (8%).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on TYRVAYA use in pregnant women to inform any drug associated risks. In animal reproduction studies, varenicline did not produce malformations at clinically relevant doses. All pregnancies have a risk of birth defect, loss, or other adverse outcomes.
In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. While no fetal structural abnormalities occurred in either species, maternal toxicity, characterized by reduced body weight gain, and reduced fetal weights occurred in rabbits at the highest dose (4864 times the MRHD on a mg/m 2 basis).
In a pre- and postnatal development study, pregnant rats received up to 15 mg/kg/day of oral varenicline succinate from organogenesis through lactation. Maternal toxicity, characterized by a decrease in body weight gain, was observed at 15 mg/kg/day (1216 times the MRHD on a mg/m 2 basis). Decreased fertility and increased auditory startle response occurred in offspring at the highest maternal dose of 15 mg/kg/day.
8.2Lactation Risk Summary There are no data on the presence of varenicline in human milk, the effects on the breastfed infant, or the effects on milk production. In animal studies varenicline was present in milk of lactating rats. However, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk.
The lack of clinical data during lactation precludes a clear determination of the risk of TYRVAYA to an infant during lactation; however, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TYRVAYA and any potential adverse effects on the breastfed child from TYRVAYA.
8.4Pediatric Use Safety and efficacy of TYRVAYA in pediatric patients have not been established.
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on TYRVAYA use in pregnant women to inform any drug associated risks. In animal reproduction studies, varenicline did not produce malformations at clinically relevant doses. All pregnancies have a risk of birth defect, loss, or other adverse outcomes.
In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Pregnant rats and rabbits received varenicline succinate during organogenesis at oral doses up to 15 and 30 mg/kg/day, respectively. While no fetal structural abnormalities occurred in either species, maternal toxicity, characterized by reduced body weight gain, and reduced fetal weights occurred in rabbits at the highest dose (4864 times the MRHD on a mg/m 2 basis).
In a pre- and postnatal development study, pregnant rats received up to 15 mg/kg/day of oral varenicline succinate from organogenesis through lactation. Maternal toxicity, characterized by a decrease in body weight gain, was observed at 15 mg/kg/day (1216 times the MRHD on a mg/m 2 basis). Decreased fertility and increased auditory startle response occurred in offspring at the highest maternal dose of 15 mg/kg/day.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy of TYRVAYA in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The efficacy of TYRVAYA in dry eye disease is believed to be the result of varenicline's activity at heteromeric sub-type(s) of the nicotinic acetylcholine (nACh) receptor where its binding produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Varenicline binds with high affinity and selectivity at human α4β2, α4α6β2, α3β4, α3α5β4 and α7 neuronal nicotinic acetylcholine receptors.
The exact mechanism of action is unknown at this time.
12.3Pharmacokinetics Absorption/Distribution Following administration of 0.12 mg (0.06 mg per 50-µL spray in each nostril), a strength of varenicline that is higher than the labeled concentration, varenicline can be detected in plasma by 5 minutes, generally achieves peak concentration within 2 hours, with a mean C max of 0.34 ng/mL, and has an AUC 0-inf of 7.46 h*ng/mL. The systemic exposure (AUC 0-inf ) following this intranasal dose was approximately 7.5% of the exposure observed following a 1 mg oral dose of varenicline.
Metabolism/Elimination The mean ± SD elimination half-life of varenicline after intranasal administration is approximately 19 ± 10 hours. Varenicline undergoes minimal metabolism with 92% excreted as unchanged drug in the urine.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The efficacy of TYRVAYA in dry eye disease is believed to be the result of varenicline's activity at heteromeric sub-type(s) of the nicotinic acetylcholine (nACh) receptor where its binding produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Varenicline binds with high affinity and selectivity at human α4β2, α4α6β2, α3β4, α3α5β4 and α7 neuronal nicotinic acetylcholine receptors.
The exact mechanism of action is unknown at this time.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied TYRVAYA (varenicline solution) nasal spray is available in a carton containing two (2) nasal spray amber glass Type I bottles. Each bottle consists of a white nasal pump and blue dust cover, delivering 0.03 mg varenicline per spray (0.05 mL). Each bottle delivers one spray in each nostril twice daily for 15 days.
Two nasal spray bottles in each carton, containing 60 sprays per bottle, equivalent to 30-days’ supply with one spray in each nostril twice daily (NDC 73521-030-02).
16.2Storage and Handling • Store TYRVAYA nasal spray at 20°C to 25°C (68°F to 77°F). Do not freeze. • Discard TYRVAYA nasal spray bottle 30 days after opening bottle.
16.1How Supplied TYRVAYA (varenicline solution) nasal spray is available in a carton containing two (2) nasal spray amber glass Type I bottles. Each bottle consists of a white nasal pump and blue dust cover, delivering 0.03 mg varenicline per spray (0.05 mL). Each bottle delivers one spray in each nostril twice daily for 15 days.
Two nasal spray bottles in each carton, containing 60 sprays per bottle, equivalent to 30-days’ supply with one spray in each nostril twice daily (NDC 73521-030-02).
📦 Storage and Handling ▾
16.2Storage and Handling • Store TYRVAYA nasal spray at 20°C to 25°C (68°F to 77°F). Do not freeze. • Discard TYRVAYA nasal spray bottle 30 days after opening bottle.
📋 Description ▾
11 DESCRIPTION TYRVAYA nasal spray contains varenicline which is a partial nicotinic acetylcholine receptor agonist of α4β2, α4α6β2, α3β4, and α3α5β4 receptors and a full α7 receptor agonist. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid whose chemical name is 7,8,9,10-tetrahydro-6,10-methano-6 H -pyrazino[2,3-h][3]benzazepine, (2 R ,3 R )-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water.
Varenicline tartrate has a molecular weight of 361.35 Daltons and a molecular formula of C 13 H 13 N 3 •C 4 H 6 O 6 . The chemical structure is: TYRVAYA (varenicline solution) nasal spray is formulated for intranasal use as a clear 0.6 mg/mL strength solution, at pH 6.4. After priming [see Dosage and Administration (2.2) ] , each actuation delivers a 0.05 mL spray containing 0.03 mg varenicline free base, equivalent to 0.05 mg of varenicline tartrate.
The formulation also contains the following inactive ingredients: monobasic sodium phosphate anhydrous, sodium chloride, sodium phosphate dibasic heptahydrate, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection. The chemical structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION • Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). • Instruct patients that TYRVAYA works to increase tear production in the eye after being sprayed in the nose. • Instruct patients to prime the bottle before using it for the first time by pumping seven (7) sprays into the air away from the face and to re-prime it by pumping 1 spray into the air away from the face if the bottle has not been used in more than five (5) days. • Instruct patients to wipe the nasal applicator with a clean tissue after each use. • Instruct patients to not shake or freeze the bottle.
Distributed by: Oyster Point Pharma, Inc., a Viatris Company Morgantown, WV 26505 U.S.A. Copyrights and Trademarks are property of their respective owners. TYRVAYA ® is a registered trademark of Oyster Point Pharma, Inc., a Viatris Company.
TYRVAYA ® and/or the use of TYRVAYA ® in a method may be covered by one or more patents or patent applications, www.oysterpointrx.com/patent-notices. © 2026 Viatris Inc. OYP:TYRVA:R2