DrugDashboards

Cobenfy

xanomeline and trospium chloride · XANOMELINE 100 mg/1; TROSPIUM CHLORIDE 20 mg/1 · Capsule, Coated Pellets · Oral · E.R. Squibb & Sons, L.L.C.

NDC 00003-1100-14 · 14 CAPSULE, COATED PELLETS in 1 BLISTER PACK · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles.

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 00003-1100-60) — 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ⓘ
$30.95per unit
middle half $29.87–$31.89 · 5,496 plans · Apr 1, 2026
Est. net of rebatesⓘ
$18.57–$23.21
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 55% · step therapy 8% · qty limit 95%

*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

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for xanomeline and trospium chloride (oral solid) in the next 90 days

sole-source market · price up 2% YoY

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 →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $1,533.17 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA216158
TE code
—
Approval date
Sep 26, 2024
Patents / exclusivity
33 patents, 3 exclusivities
TypeNumber / codeExpires
exclusivityNCESep 26, 2029
exclusivityNCESep 26, 2029
exclusivityNCESep 26, 2029
patent12558317Oct 29, 2039
patent12558317Oct 29, 2039
patent12558317Oct 29, 2039
patent11452692Sep 27, 2039
patent11452692Sep 27, 2039
patent11452692Sep 27, 2039
patent10933020Sep 27, 2039
patent10933020Sep 27, 2039
patent10933020Sep 27, 2039

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of xanomeline and trospium chloride (Capsule, Coated Pellets)

LabelerStrengthFirst seenLast seen
E.R. Squibb & Sons, L.L.C.XANOMELINE 50 mg/1; TROSPIUM CHLORIDE 20 mg/1Aug 26, 2026Sep 2, 2026
E.R. Squibb & Sons, L.L.C.XANOMELINE 100 mg/1; TROSPIUM CHLORIDE 20 mg/1Aug 26, 2026Sep 2, 2026
E.R. Squibb & Sons, L.L.C.XANOMELINE 125 mg/1; TROSPIUM CHLORIDE 30 mg/1Aug 26, 2026Sep 2, 2026
E.R. Squibb & Sons, L.L.C.XANOMELINE 30 mg/1; TROSPIUM CHLORIDE 125 mg/1Jul 22, 2026Aug 19, 2026
E.R. Squibb & Sons, L.L.C.XANOMELINE 20 mg/1; TROSPIUM CHLORIDE 100 mg/1Jul 22, 2026Aug 19, 2026
E.R. Squibb & Sons, L.L.C.XANOMELINE 20 mg/1; TROSPIUM CHLORIDE 50 mg/1Jul 22, 2026Aug 19, 2026
E.R. Squibb & Sons, L.L.C.TROSPIUM CHLORIDE 20 mg/1; XANOMELINE 100 mg/1Jul 15, 2026Jul 15, 2026
E.R. Squibb & Sons, L.L.C.TROSPIUM CHLORIDE 20 mg/1; XANOMELINE 50 mg/1Jul 15, 2026Jul 15, 2026
E.R. Squibb & Sons, L.L.C.TROSPIUM CHLORIDE 30 mg/1; XANOMELINE 125 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Cobenfy — NDC 00003-1100-14," retrieved September 3, 2026, https://drugdashboards.com/drug/00003110014.

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