Carbamazepine - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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

Carbamazepine is the generic ingredient in eight branded drugs marketed by Apotex Inc, Mylan Ireland Ltd, Taro, Teva Pharms, Shire Dev Llc, Validus Pharms, Lundbeck Pharms Llc, Wockhardt Bio Ag, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Usl Pharma, and Warner Chilcott, and is included in thirty 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 seventy-two patent family members in twenty countries.

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

Summary for carbamazepine

International Patents:	72
US Patents:	7
Tradenames:	8
Applicants:	19
NDAs:	30
Drug Master File Entries:	27
Suppliers / Packagers:	35
Bulk Api Vendors:	128
Clinical Trials:	139
Patent Applications:	6,302
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for carbamazepine
Drug Sales Revenues:	Drug sales revenues for carbamazepine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carbamazepine
DailyMed Link:	carbamazepine at DailyMed

See drug prices for carbamazepine

Drug Sales Revenue Trends for carbamazepine

See drug sales revenues for carbamazepine

Recent Clinical Trials for carbamazepine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Veloxis Pharmaceuticals	Phase 4
Temple University	Phase 4
Eisai Inc.	Phase 4

See all carbamazepine clinical trials

Recent Litigation for carbamazepine

Identify potential future generic entrants

District Court Litigation

Case Name	Date
CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA	2019-05-23
ADAMAS PHARMA, LLC v. SANDOZ INC.	2018-05-10
MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED	2018-03-29

See all carbamazepine litigation

Generic filers with tentative approvals for CARBAMAZEPINE

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

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

(z)-5h-dibenzo[b,f]azepine-5-carboxamide
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
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-carboxamide;Oxcarbazepine IMpurity A
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
BCP21380
BDBM50003659
benzo[b][1]benzazepine-11-carboxamide
BG0497
BIDD:GT0479
BIM-0050280.0001
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 (JP17/USP/INN)
carbamazepine (Tegretol)
Carbamazepine [USAN:INN:BAN:JAN]
Carbamazepine [USAN:USP:INN:BAN:JAN]
Carbamazepine 1.0 mg/ml in Methanol
Carbamazepine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Carbamazepine, 98%
Carbamazepine, analytical standard
Carbamazepine, British Pharmacopoeia (BP) Reference Standard
Carbamazepine, European Pharmacopoeia (EP) Reference Standard
Carbamazepine, meets USP testing specifications
Carbamazepine, Pharmaceutical Secondary Standard; Certified Reference Material
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
DB00564
dibenzo[b,f]azepine-5-carboxamide
Dibenzo[b,f]azepine-5-carboxylic acid amide(Carbamazepine)
DivK1c_000388
DivK1c_003750
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
HMS3712K05
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
MFCD00005073 (97+%)
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
Prestwick_104
Prestwick0_000052
Prestwick1_000052
Prestwick2_000052
Prestwick3_000052
Q-200792
s1693
SAM002264603
SBI-0050280.P004
SC-16243
SCHEMBL19838283
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
SR-01000000229-4
SR-01000000229-7
ST075773
ST2418853
Stazepin
Stazepine
STK177357
STL453548
SW220141-1
SY002823
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

Paragraph IV (Patent) Challenges for CARBAMAZEPINE

Tradename	Dosage	Ingredient	NDA	Submissiondate
EQUETRO	CAPSULE, EXTENDED RELEASE;ORAL	carbamazepine	021710	2014-05-23
EQUETRO	CAPSULE, EXTENDED RELEASE;ORAL	carbamazepine	021710	2007-08-21
CARBATROL	CAPSULE, EXTENDED RELEASE;ORAL	carbamazepine	020712	2006-02-02
TEGRETOL-XR	TABLET, EXTENDED RELEASE;ORAL	carbamazepine	020234	2005-12-30

US Patents and Regulatory Information for carbamazepine

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;INTRAVENOUS	206030-001	Oct 7, 2016		DISCN	Yes	No	Start Trial	Start Trial	Y			Start Trial
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996	AB	RX	Yes	No	Start Trial	Start Trial				Start Trial
Novartis	TEGRETOL	carbamazepine	SUSPENSION;ORAL	018927-001	Dec 18, 1987	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Teva	EPITOL	carbamazepine	TABLET;ORAL	070541-001	Sep 17, 1986	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Taro Pharm Inds	CARBAMAZEPINE	carbamazepine	TABLET, CHEWABLE;ORAL	075687-001	Oct 24, 2000	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Torrent Pharms	CARBAMAZEPINE	carbamazepine	TABLET;ORAL	077272-004	Dec 7, 2005		RX	No	No	Start Trial	Start Trial				Start Trial
Taro	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	078115-003	Mar 31, 2009	AB	RX	No	No	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for carbamazepine

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TEGRETOL	carbamazepine	TABLET, CHEWABLE;ORAL	018281-001	Approved Prior to Jan 1, 1982	Start Trial	Start Trial
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-003	Dec 10, 2004	Start Trial	Start Trial
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	Start Trial	Start Trial
Shire Dev Llc	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	Sep 30, 1997	Start Trial	Start Trial
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996	Start Trial	Start Trial
Shire Dev Llc	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	Start Trial	Start Trial
Shire Dev Llc	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for carbamazepine

Subscribe to access the full database, or Start Trial
Country	Patent Number	Estimated Expiration
Israel	243654	Start Trial
Spain	2475157	Start Trial
South Korea	101633479	Start Trial
Brazil	PI0616447	Start Trial
South Korea	101314803	Start Trial
Mexico	352459	Start Trial
Canada	2702603	Start Trial
>Country	>Patent Number	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.