Timolol hemihydrate

Timolol hemihydrate · TIMOLOL MALEATE 5 mg/mL · Solution/ Drops · Ophthalmic · Somerset Therapeutics, LLC

NDC 70069-0516-01 · 1 BOTTLE in 1 CARTON / 2.5 mL in 1 BOTTLE · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price is down 29% over the past year, to $16.68 per mL. One of its named manufacturing plants, Somerset Therapeutics Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. 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.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 70069-0517-01) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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ⓘ

$43.11per unit

middle half $39.73–$58.25 · 1,999 plans · Apr 1, 2026

Est. net of rebatesⓘ

≈ $43.11

generic — rebates are minimal, so net ≈ gross

Coverage & restrictions

36%of plans cover it

tier 4 · prior auth 0% · step therapy 0% · qty limit 0%

*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 6 quarters since 2024.

NADAC price per unit

20 price points · per MLSource: CMS NADAC

Estimated fill cost

WAC per package, as filed

$122.49

Reported to Texas DSHS · 2026 annual filing · Somerset Therapeutics, LLC

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

Supply fragility

38● Elevated 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
price down 27% year over year+8

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)

0.2%chance of a new FDA shortage posting for timolol hemihydrate (other) in the next 90 days

OAI inspection at a producing facility (24 months) · 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 →

Where it's made

Somerset Therapeutics Private LimitedOAIIndia
analysis · label · manufacture · pack

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Regulatory

Application: ANDA216653
TE code: AT2
Approval date: Jul 3, 2024
Patents / exclusivity: None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Timolol hemihydrate (Solution/ Drops)

Labeler	Strength	First seen	Last seen
Somerset Therapeutics, LLC	TIMOLOL ANHYDROUS 5 mg/mL	Jul 15, 2026	Sep 3, 2026
Somerset Therapeutics, LLC	TIMOLOL MALEATE 5 mg/mL	Jul 15, 2026	Sep 2, 2026

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

Cite this page

DrugDashboards, "Timolol hemihydrate — NDC 70069-0516-01," retrieved September 3, 2026, https://drugdashboards.com/drug/70069051601.

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