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CARNEXIV

NDA

CARBAMAZEPINE | N206030 | LUNDBECK PHARMACEUTICALS LLC

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

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Today

Mar. 13, 2029

Mar. 13, 2029

Feb. 27, 2033

Nov. 10, 2028

Mar. 13, 2029

Nov. 10, 2028

Jan. 31, 2040

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

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.

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

2 letters from Drugs@FDA

Date	Submission	Document
Dec 13, 2019	SUPPL -2	View Letter (PDF)
Oct 12, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG/20ML (10MG/ML)

RLD

7 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Oct 7, 2016

Patents (7) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7635773	Mar 13, 2029	—	—	Yes	—	—
8410077	Mar 13, 2029	—	—	Yes	—	—
9493582	Feb 27, 2033	—	—	Yes	—	—
9629797	Nov 10, 2028	—	—	—		—
9750822	Mar 13, 2029	—	—	Yes	—	—
9770407	Nov 10, 2028	—	—	Yes	—	—
11529357	Jan 31, 2040	—	—	Yes	—	—