DrugDashboards

Qudexy Xr

Topiramate · TOPIRAMATE 100 mg/1 · Capsule, Extended Release · Oral · Upsher-Smith Laboratories, LLC

NDC 00245-1074-90 · 1 BOTTLE in 1 CARTON / 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE · NDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply.

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 68382-0769-06) — 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ⓘ
$15.36per unit
middle half $12.14–$17.15 · 889 plans · Apr 1, 2026
Est. net of rebatesⓘ
$9.21–$11.52
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
16%of plans cover it
tier 4 · prior auth 24% · step therapy 0% · qty limit 2%

*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

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 topiramate (oral solid) 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

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

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 $1,818.96 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA205122
TE code
AB2
Approval date
Mar 11, 2014
Patents / exclusivity
25 patents, 0 exclusivities
TypeNumber / codeExpires
patent10363224Mar 19, 2033
patent10363224Mar 19, 2033
patent10363224Mar 19, 2033
patent10363224Mar 19, 2033
patent10363224Mar 19, 2033
patent9555005Mar 19, 2033
patent9101545Mar 19, 2033
patent8889190Mar 19, 2033
patent8889190Mar 19, 2033
patent8652527Mar 19, 2033
patent8652527Mar 19, 2033
patent9555005Mar 19, 2033

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Topiramate (Capsule, Extended Release)

LabelerStrengthFirst seenLast seen
Ajanta Pharma USA Inc.TOPIRAMATE 100 mg/1Jul 15, 2026Sep 3, 2026
Ajanta Pharma USA Inc.TOPIRAMATE 50 mg/1Jul 15, 2026Sep 3, 2026
Ajanta Pharma USA Inc.TOPIRAMATE 25 mg/1Jul 15, 2026Sep 3, 2026
Catalent Pharma Solutions, LLCTOPIRAMATE 100 mg/1Jul 15, 2026Sep 3, 2026
Teva Pharmaceuticals, Inc.TOPIRAMATE 100 mg/1Jul 15, 2026Sep 3, 2026
Teva Pharmaceuticals, Inc.TOPIRAMATE 25 mg/1Jul 15, 2026Sep 3, 2026
Upsher-Smith Laboratories, LLCTOPIRAMATE 100 mg/1Jul 15, 2026Sep 3, 2026
Upsher-Smith Laboratories, LLCTOPIRAMATE 150 mg/1Jul 15, 2026Sep 3, 2026
Upsher-Smith Laboratories, LLCTOPIRAMATE 50 mg/1Jul 15, 2026Sep 3, 2026
Zydus Lifesciences LimitedTOPIRAMATE 50 mg/1Jul 15, 2026Sep 3, 2026
Zydus Lifesciences LimitedTOPIRAMATE 25 mg/1Jul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.TOPIRAMATE 50 mg/1Jul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.TOPIRAMATE 25 mg/1Jul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.TOPIRAMATE 100 mg/1Jul 15, 2026Sep 3, 2026
Ajanta Pharma USA Inc.TOPIRAMATE 150 mg/1Jul 15, 2026Sep 2, 2026
AvKARETOPIRAMATE 25 mg/1Jul 15, 2026Sep 2, 2026
AvKARETOPIRAMATE 200 mg/1Jul 15, 2026Sep 2, 2026
AvKARETOPIRAMATE 50 mg/1Jul 15, 2026Sep 2, 2026
AvKARETOPIRAMATE 100 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TOPIRAMATE 25 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TOPIRAMATE 100 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TOPIRAMATE 200 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.TOPIRAMATE 50 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions LLCTOPIRAMATE 25 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions LLCTOPIRAMATE 100 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions LLCTOPIRAMATE 50 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions LLCTOPIRAMATE 200 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCTOPIRAMATE 200 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCTOPIRAMATE 50 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCTOPIRAMATE 150 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCTOPIRAMATE 25 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories Inc.TOPIRAMATE 50 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories Inc.TOPIRAMATE 200 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories Inc.TOPIRAMATE 100 mg/1Jul 15, 2026Sep 2, 2026
Dr. Reddys Laboratories Inc.TOPIRAMATE 25 mg/1Jul 15, 2026Sep 2, 2026
Endo USA, Inc.TOPIRAMATE 50 mg/1Jul 15, 2026Sep 2, 2026
Endo USA, Inc.TOPIRAMATE 100 mg/1Jul 15, 2026Sep 2, 2026
Endo USA, Inc.TOPIRAMATE 25 mg/1Jul 15, 2026Sep 2, 2026
Endo USA, Inc.TOPIRAMATE 200 mg/1Jul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., USATOPIRAMATE 25 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Qudexy Xr — NDC 00245-1074-90," retrieved September 3, 2026, https://drugdashboards.com/drug/00245107490.

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