Viewing data from:

CELONTIN

NDA

METHSUXIMIDE | N010596 | PARKE DAVIS DIV WARNER LAMBERT CO

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$4.40

per ea

Lowest NADAC/Unit

$4.40

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00071052524CELONTIN 300 MG CAPSULE	$4.40	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$343.29

Highest Price

$456.76

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00071-0525-24CELONTIN	$456.76	FSS	Pfizer Inc.	06/30/2029
00071-0525-24CELONTIN	$343.29	Big4	Pfizer Inc.	06/30/2029

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Celontin (2024)

Total Spending

$249K

Total Claims

587

Beneficiaries

110

Avg Cost/Unit

$4.50

Spending Trend

$1.1M(2019)→$1.2M(2020)→$1.0M(2021)→$886K(2022)→$696K(2023)→$249K(2024)

YoY Change:-4.7%

5yr CAGR:+0.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SS PHARMA LLCMETHSUXIMIDE USP

DMF 355222020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Jun 17, 2011	SUPPL -23	View Letter (PDF)
Oct 13, 2010	SUPPL -22	View Letter (PDF)
Apr 29, 2009	SUPPL -21	View Letter (PDF)
Apr 17, 2002	SUPPL -17	View Letter (PDF)
Apr 9, 2001	SUPPL -9	View Letter (PDF)
Apr 9, 2001	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#007 — 150MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#008 — 300MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982