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Carbamazepine - Generic Drug Details

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What are the generic sources for carbamazepine and what is the scope of carbamazepine freedom to operate?

Carbamazepine is the generic ingredient in eight branded drugs marketed by Apotex Inc, Mylan Ireland Ltd, Taro, Teva Pharms, Shire, Validus Pharms, Lundbeck Pharms Llc, Wockhardt Bio Ag, Novartis, Taro Pharm, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Actavis Elizabeth, Inwood Labs, Pliva, Usl Pharma, and Warner Chilcott, and is included in twenty-nine NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbamazepine has sixty patent family members in twenty countries.

There are twenty-seven drug master file entries for carbamazepine. Forty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for carbamazepine

International Patents:	60
US Patents:	7
Tradenames:	8
Applicants:	19
NDAs:	29
Drug Master File Entries:	27
Suppliers / Packagers:	42
Bulk Api Vendors:	109
Clinical Trials:	134
Patent Applications:	6,724
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carbamazepine
DailyMed Link:	carbamazepine at DailyMed

Pharmacology for carbamazepine

Drug Class	Mood Stabilizer
Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2C19 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for carbamazepine

Analgesics, Non-Narcotic

Anticonvulsants

Antimanic Agents

Cytochrome P-450 CYP3A Inducers

Synonyms for carbamazepine

11-benzo[b][1]benzazepinecarboxamide

2-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,9,12,14-heptaene-2-carboxamide

2-azatricyclo[9.4.0.0;{3,8}]pentadeca-1(11),3(8),4,6,9,12,14-heptaene-2-carboxamide

2-AZATRICYCLO[9.4.0.0(3),?]PENTADECA-1(11),3(8),4,6,9,12,14-HEPTAENE-2-CARBOXAMIDE

298-46-4

33CM23913M

5-Carbamoyl-5H-dibenz(b,f)azepine

5-Carbamoyl-5H-dibenz[b,f]azepine

5-Carbamoyl-5H-dibenzo(b,f)azepine

5-Carbamoyldibenzo(b,f)azepine

5-Carbamyl-5H-dibenzo(b,f)azepine

5-Carbamyldibenzo(b,f)azepine

5-Carbomoyl-5H-dibenzo(b,f)azepine

5H-Dibenz(b,f)azepine-5-carboxamide

5H-Dibenz[ b, f]azepine-5-carboxamide

5H-Dibenz[b,f]azepine-5- carboxamide

5H-Dibenz[b,f]azepine-5-carboxamide

5H-Dibenz[b,f]azepine-5-carboxamine

5H-Dibenzo[b,f]azepine-5-carboxamide

5H-Dibenzo[b,f]azepine-5-carboxamide #

5H-dibenzo[b,f]azepine-5-carboximidic acid

85756-57-6 (di-hydrate)

A820074

AB00051931_19

AB00051931_20

AB00051931-17

AB00051931-18

AB0070254

AB1009530

AC-9538

AC1L1DXT

AC1Q4ZSU

AC1Q4ZSV

ACT02606

AJ-08227

AJ-08230

AK116064

AKOS003235644

AKOS025397243

Amizepin

Amizepine

AN-6325

AOB5783

Apo-Carbamazepine

Atretol

Azapentacene; Sodium 5,12-dihydroazapentacene disulfonate; 5,12-Dihydroquinoxalino[2,3-b]phenazine sulfonate sodium salt

BBL005372

BC200975

BDBM50003659

benzo[b][1]benzazepine-11-carboxamide

BG0497

BIDD:GT0479

BIM-0050280.0001

Bio-0751

Bipotrol

Biston

BPBio1_000225

BRD-K71799949-001-06-7

BRN 1246090

BSPBio_000203

BSPBio_001929

C 4024

C-13993

C06868

Calepsin

Carbamazepan

Carbamazepen

Carbamazepin

Carbamazepina

Carbamazepina [INN-Spanish]

Carbamazepine (Carbatrol)

Carbamazepine (iv, epilepsy)

Carbamazepine (iv, epilepsy), Lundbeck

Carbamazepine (iv, epilepsy), Ovation Pharmaceuticals

Carbamazepine (JP17/USP/INN)

carbamazepine (Tegretol)

Carbamazepine [USAN:INN:BAN:JAN]

Carbamazepine [USAN:USP:INN:BAN:JAN]

Carbamazepine 1.0 mg/ml in Methanol

Carbamazepine Anhydrous

carbamazepine hydrate

Carbamazepine Hydrochloride

Carbamazepine Phosphate

Carbamazepine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material

carbamazepine sulfate

carbamazepine tartrate

Carbamazepine, analytical standard

Carbamazepine, British Pharmacopoeia (BP) Reference Standard

Carbamazepine, European Pharmacopoeia (EP) Reference Standard

Carbamazepine, meets USP testing specifications

Carbamazepine, pharmaceutical secondary standard; traceable to USP, PhEur and BP

Carbamazepine, powder

CARBAMAZEPINE, U.S.P.

Carbamazepine, United States Pharmacopeia (USP) Reference Standard

Carbamazepinum

Carbamazepinum [INN-Latin]

Carbamezepine

Carbatrol

Carbatrol extended-release

Carbazepin

Carbazepine

Carbelan

Carnexiv

CAS-298-46-4

CBChromo1_000350

CC-25382

CC-25383

CCG-38931

CDS1_002710

CHEBI:3387

CHEMBL108

ChemDiv1_018966

CPD001227191

CS-2225

D00252

D04MSM

DB00564

dibenz[b,f]azepine-5-carboxamide

dibenzo[b,f]azepine-5-carboxamide

Dibenzo[b,f]azepine-5-carboxylic acid amide(Carbamazepine)

DivK1c_000388

DivK1c_003750

DR000542

DSSTox_CID_2731

DSSTox_GSID_22731

DSSTox_RID_76704

DTXSID4022731

EINECS 206-062-7

EN300-21678

Epitol

Epitope ID:174842

Equetro

Equetro (TN)

EU-0100292

F0348-2551

FFGPTBGBLSHEPO-UHFFFAOYSA-N

Finlepsin

FT-0602927

FT-0696814

G 32883

G-32883

Geigy 32883

GP8250

GTPL5339

H2605

H495

HMS1568K05

HMS1920I17

HMS2090M07

HMS2091O19

HMS2095K05

HMS2233G16

HMS3039K09

HMS3259B21

HMS3260L06

HMS3372J13

HMS3657G03

HMS501D10

HMS640O02

HSDB 3019

HY-B0246

I06-0863

IDI1_000388

IMED104589831

Iminostilbene-N-carboxamide

Karbamazepin

KB-246109

KBio1_000388

KBio2_000516

KBio2_003084

KBio2_005652

KBio3_001149

KBioGR_000724

KBioSS_000516

KS-00000KI8

KS-5146

Lexin

Lopac-C-4024

Lopac0_000292

LP00292

LS-60362

MCULE-9121567287

MFCD00005073

MLS000069652

MLS001055475

MLS001074172

MLS002548877

MolPort-000-710-574

MolPort-023-220-275

NC00679

NCGC00015234-01

NCGC00015234-02

NCGC00015234-03

NCGC00015234-04

NCGC00015234-05

NCGC00015234-06

NCGC00015234-07

NCGC00015234-08

NCGC00015234-09

NCGC00015234-10

NCGC00015234-11

NCGC00015234-12

NCGC00015234-13

NCGC00015234-14

NCGC00015234-15

NCGC00015234-16

NCGC00015234-19

NCGC00023877-03

NCGC00023877-04

NCGC00023877-05

NCGC00023877-06

NCGC00023877-07

NCGC00023877-08

NCGC00253982-01

NCGC00259822-01

NCGC00260977-01

Neurotol

Neurotop retard

NINDS_000388

Novo-Carbamaz

NSC 169864

NSC-169864

NSC-755920

NSC169864

NSC755920

Nu-Carbamazepine

Opera_ID_72

Oprea1_790775

Pharmakon1600-01500159

PL053430

Prestwick_104

Prestwick0_000052

Prestwick1_000052

Prestwick2_000052

Prestwick3_000052

Q-200792

s1693

SAM002264603

SBI-0050280.P004

SC-16243

SCHEMBL21639

Sirtal

SMR000058201

SMR001227191

SPBio_000170

SPBio_002124

SPD-417

Spectrum_000096

SPECTRUM1500159

Spectrum2_000125

Spectrum3_000325

Spectrum4_000262

Spectrum5_000936

SR-01000000229

SR-01000000229-2

ST075773

ST2418853

Stazepin

Stazepine

STK177357

STL453548

Taro-Carbamazepine

Taro-Carbamazepine Cr

Tegretal

Tegretol

Tegretol (TN)

Tegretol Chewtabs

Tegretol Cr

Tegretol-Xr

Telesmin

Teril

Timonil

Tox21_110104

Tox21_110104_1

Tox21_202273

Tox21_300195

Tox21_500292

Trimonil

UNII-33CM23913M

WLN: T C676 BNJ BVZ

Z2199879032

ZB000594

ZINC4785

Tentative approvals for CARBAMAZEPINE

Applicant	Application No.	Strength	Dosage Form
		100MG	CAPSULE, EXTENDED RELEASE; ORAL
		300MG	CAPSULE, EXTENDED RELEASE; ORAL
		200MG	CAPSULE, EXTENDED RELEASE; ORAL

US Patents and Regulatory Information for carbamazepine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	CARBAMAZEPINE	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	201106-002	Jun 21, 2013	AB	RX	No	No
Pliva	CARBAMAZEPINE	carbamazepine	TABLET;ORAL	071479-001	Jul 24, 1987		DISCN	No	No
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-003	Mar 25, 1996	AB	RX	Yes	Yes
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;IV (INFUSION)	206030-001	Oct 7, 2016		DISCN	Yes	No

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Expired US Patents for carbamazepine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996
Shire	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997
Novartis	TEGRETOL	carbamazepine	TABLET;ORAL	016608-001	Approved Prior to Jan 1, 1982

Non-Orange Book US Patents for carbamazepine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,200,088	Sulfoalkyl ether cyclodextrin compositions

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International Patents for carbamazepine

Country	Document Number	Estimated Expiration
Canada	2771879
China	101309691
World Intellectual Property Organization (WIPO)	2013130666
Brazil	PI0616447