DrugDashboards

Tyrvaya

varenicline · VARENICLINE TARTRATE .03 mg/.05mL · Spray · Nasal · Oyster Point Pharma, Inc.

NDC 73521-0030-02 · 2 BOTTLE, PUMP in 1 CARTON / 4.2 mL in 1 BOTTLE, PUMP · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has held steady around $79.60 per mL over the past year. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$79.60per MLinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$76.54per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$84.70per unitnegotiated price across 1,069 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$497.77per package of 2x4.2MLOyster Point Pharma, Inc. · Jan 1, 2026

Medicare Part D

All Part D pricing →
ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$84.70per unit
middle half $83.64$85.31 · 1,069 plans · Apr 1, 2026
Est. net of rebates
$50.82–$63.52
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
19%of plans cover it
tier 4 · prior auth 0% · step therapy 3% · qty limit 96%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

$0$50.00$100.00Aug 2022Sep 2026$79.60
27 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$699.10
Reported to Texas DSHS · 2026 annual filing · Oyster Point Pharma, Inc.

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2025)

$5.6M
8,348 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for varenicline (other) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Regulatory

Application
NDA213978
TE code
Approval date
Oct 15, 2021
Patents / exclusivity
12 patents, 0 exclusivities
TypeNumber / codeExpires
patent11224598Oct 19, 2035
patent10456396Oct 19, 2035
patent9597284Oct 19, 2035
patent9532944Oct 19, 2035
patent9504644Oct 19, 2035
patent11911380Oct 19, 2035
patent11903943Oct 19, 2035
patent11903941Oct 19, 2035
patent12576080Oct 19, 2035
patent12653824Oct 19, 2035
patent9504645Oct 19, 2035
patent11903942Oct 19, 2035

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of varenicline (Spray)

LabelerStrengthFirst seenLast seen
Oyster Point Pharma, Inc.VARENICLINE TARTRATE .03 mg/.05mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Tyrvaya — NDC 73521-0030-02," retrieved September 3, 2026, https://drugdashboards.com/drug/73521003002.

Free to cite with attribution — see how the data is put together.