Viewing data from:

TEGRETOL

NDA

CARBAMAZEPINE | N016608 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from Taro Pharmaceuticals USA, Inc. FDA-2003-P-0352 · 5 docket documents Taro Pharmaceuticals USA, Inc. filed this citizen petition on July 1, 2003, requesting that the FDA determine ANDA suitability for Carbamazepine Oral Suspension USP, 200 mg/5 mL using Tegretol Oral Suspension, 100 mg/5 mL manufactured by Novartis Pharmaceuticals Corporation as the reference-listed d	Other	2010-10-04	Denied	Taro Pharmaceuticals USA, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

67 trials from ClinicalTrials.gov, 56 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment NCT00004758	Phase 2	Completed	National Center for Research Resources (NCRR)	30	1993-11
Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania NCT00190892	Phase 4	Completed	Eli Lilly and Company	120	2004-09 → 2006-06
Prediction of Childhood Epilepsy Outcome in Bangladesh NCT00381537	N/A	Completed	Institute of Child Health	92	—
The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy NCT00807989	Phase 4	Completed	Yonsei University	207	2008-03 → 2012-05
The Young Adult and Pediatric Bipolar Study NCT00350857	Phase 4	Completed	Validus Pharmaceuticals	161	2006-07 → 2007-10
Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy NCT01128959	Phase 3	Completed	Lundbeck LLC	108	2010-06 → 2013-01
A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers NCT01629368	Phase 1	Completed	Hoffmann-La Roche	16	2012-06 → 2012-09
Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults NCT02912364	Phase 4	Completed	Stanford University	46	2016-07 → 2018-04-20
A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants NCT04330248	Phase 1	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	15	2020-03-31 → 2022-06-14
Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder NCT00266630	Phase 3	Completed	Eli Lilly and Company	139	2005-11 → 2009-05

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

Drug Pricing (NADAC)

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

Highest NADAC/Unit

$3.04

per ea

Lowest NADAC/Unit

$3.04

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00078050905TEGRETOL 200 MG TABLET	$3.04	EA	Brand	$0.1186	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

$229.28

Highest Price

$285.04

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0509-05TEGRETOL	$285.04	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0509-05TEGRETOL	$229.28	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

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

Medicare Part D Spending

CMS annual spending data for Tegretol (2024)

Total Spending

$11.6M

Total Claims

21,732

Beneficiaries

3,532

Avg Cost/Unit

$2.67

Spending Trend

$14.3M(2019)→$13.8M(2020)→$13.1M(2021)→$12.3M(2022)→$13.1M(2023)→$11.6M(2024)

YoY Change:-4.8%

5yr CAGR:+2.9%

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

API Supply Chain10 active DMFs16 inactive

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

SIEGFRIED EVIONNAZ SACARBAMAZEPINE

DMF 43411981

TAPI NL BVCARBAMAZEPINE USP

DMF 47191982

TARO PHARMACEUTICAL INDUSTRIES LTDCARBAMAZEPINE USP

DMF 49291983

FIS FABBRICA ITALIANA SINTETICI SPACARBAMAZEPINE

DMF 66411986

JUBILANT BIOSYS LTDCARBAMAZEPINE USP

DMF 144101999

SIEGFRIED EVIONNAZ SACARBAMAZEPINE (CARBATOL)

DMF 151952000

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)CARBAMAZEPINE USP

DMF 231702009

CTX LIFE SCIENCES PVT LTDCARBAMAZEPINE USP

DMF 241952010

ZAKLADY FARMACEUTYCZNE POLPHARMA SACARBAMAZEPINE

DMF 262662012

DASAMI LAB PRIVATE LTDCARBAMAZEPINE USP

DMF 361642021

ORION CORP LTDInactiveCARBAMAZEPINE USP XX

DMF 56651984

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveCARBAMAZEPINE

DMF 67421986

HEXAGON LABORATORIES INCInactiveCARBAMAZEPINE USP

DMF 67481986

SHANGHAI NO 2 PHARMACEUTICAL FACTORYInactiveCARBAMAZEPINE

DMF 71631987

AMERICAN CHEMICAL INDUSTRIAL CORPInactiveCARBAMAZEPINE

DMF 72881988

FREEDOM CHEMICAL DIAMALT GMBHInactiveCARBAMAZEPINE

DMF 77441988

CL PHARMA AGInactiveCARBAMAZEPINE

DMF 78151988

VIS FARMACEUTICI INSTITUTO SCIENTIFICO VINEZIE SPAInactiveCARBAMAZEPINE

DMF 78271988

CHEMWERTH INCInactiveCARBAMAZEPINE

DMF 79041989

FARCHEMIA SRLInactiveCARBAMAZEPINE

DMF 99671992

ARZNEIMITTELWERK DRESDEN GMBHInactiveCARBAMAZEPINE

DMF 119011996

MAX INDIA LTDInactiveCARBAMAZEPINE BULK DRUG SUBSTANCE

DMF 125121997

TEVA GROUPInactiveCARBAMAZEPINE USP

DMF 131251998

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveCARBAMAZEPINE USP

DMF 148932000

PHARMAZELL GMBHInactiveCARBAMAZEPINE

DMF 203762007

PHARMAZELL GMBHInactiveCARBAMAZEPINE (PROCESS II)

DMF 233282009

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Oct 2, 2025	SUPPL -122	View Letter (PDF)
Sep 14, 2023	SUPPL -121	View Letter (PDF)
Mar 22, 2018	SUPPL -116	View Letter (PDF)
Sep 1, 2015	SUPPL -97	View Letter (PDF)
Sep 17, 2014	SUPPL -99	View Letter (PDF)
Jan 17, 2014	SUPPL -103	View Letter (PDF)
Mar 8, 2013	SUPPL -105	View Letter (PDF)
Dec 13, 2012	SUPPL -107	View Letter (PDF)
Nov 10, 2011	SUPPL -106	View Letter (PDF)
Mar 7, 2011	SUPPL -102	View Letter (PDF)
Mar 7, 2011	SUPPL -100	View Letter (PDF)
May 1, 2009	SUPPL -101	View Letter (PDF)
Jan 9, 2008	SUPPL -98	View Letter (PDF)
Aug 17, 2007	SUPPL -96	View Letter (PDF)
Mar 7, 2001	SUPPL -90	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.