Viewing data from:

FELBATOL

NDA

FELBAMATE | N020189 | MYLAN SPECIALTY LP

3 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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Clinical Trial of Felbamate for Treatment-Resistant Bipolar Depression NCT00034229	Phase 2	Completed	National Institute of Mental Health (NIMH)	52	2002-04 → 2006-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$16.83

per ea

Lowest NADAC/Unit

$14.70

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00037043101FELBATOL 600 MG TABLET	$16.83	EA	Brand	$1.05	2026-10-21
00037043001FELBATOL 400 MG TABLET	$14.70	EA	Brand	$0.8512	2026-10-21

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$1110.71

Highest Price

$1275.02

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00037-0430-01FELBATOL 400MG TAB	$1110.71	Big4	Mylan Specialty L.P.	01/14/2027
00037-0430-01FELBATOL 400MG TAB	$1110.71	FSS	Mylan Specialty L.P.	01/14/2027
00037-0431-01FELBATOL 600MG TAB	$1275.02	Big4	Mylan Specialty L.P.	01/14/2027
00037-0431-01FELBATOL 600MG TAB	$1275.02	FSS	Mylan Specialty L.P.	01/14/2027

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

Medicare Part D Spending

CMS annual spending data for Felbatol (2024)

Total Spending

$5.7M

Total Claims

1,837

Beneficiaries

237

Avg Cost/Unit

$15.52

Spending Trend

$9.6M(2019)→$10.0M(2020)→$10.0M(2021)→$9.5M(2022)→$7.3M(2023)→$5.7M(2024)

YoY Change:-3.3%

5yr CAGR:+3.3%

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

API Supply Chain8 active DMFs5 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED EVIONNAZ SAFELBAMATE

DMF 83041989

PROCOS SPAFELBAMATE

DMF 212472008

SOLARA ACTIVE PHARMA SCIENCES LTDFELBAMATE

DMF 228102009

MATRIX PHARMACORP PRIVATE LTDFELBAMATE USP

DMF 229582009

TARO PHARMACEUTICAL INDUSTRIES LTDFELBAMATE USP

DMF 273312013

EMCURE PHARMACEUTICALS LTDFELBAMATE USP

DMF 294082015

RAKS PHARMA PVT LTDFELBAMATE USP

DMF 311812016

MATRIX PHARMACORP PRIVATE LTDFELBAMATE USP (FEL)

DMF 392072023

ZACH SYSTEMInactiveFELBAMATE

DMF 92681991

GANES CHEMICALS INC PENNSVILLE DIVInactiveFELBAMATE

DMF 93521991

APICORE US LLCInactiveFELBAMATE

DMF 204382007

HETERO DRUGS LTDInactiveFELBAMATE

DMF 222012008

ENALTEC LABS PRIVATE LTDInactiveFELBAMATE USP

DMF 286612015

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Sep 5, 2012	SUPPL -27	View Letter (PDF)
Jul 7, 2011	SUPPL -23	View Letter (PDF)
May 1, 2009	SUPPL -22	View Letter (PDF)
Nov 19, 2002	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 400MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 29, 1993

No patent or exclusivity listings for this strength.

#002 — 600MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 29, 1993

#003 — 600MG/5ML

RLD

0 patents0 exclusivities▾

SUSPENSION;ORAL | Approved: Jul 29, 1993