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Last Updated: October 21, 2019

DrugPatentWatch Database Preview

TRILEPTAL Drug Profile

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When do Trileptal patents expire, and what generic alternatives are available?

Trileptal is a drug marketed by Novartis and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has forty-six patent family members in thirty-three countries.

The generic ingredient in TRILEPTAL is oxcarbazepine. There are twenty-one drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the oxcarbazepine profile page.

Drug patent expirations by year for TRILEPTAL
Drug Prices for TRILEPTAL

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Drug Sales Revenue Trends for TRILEPTAL

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Recent Clinical Trials for TRILEPTAL

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

SponsorPhase
Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen HospitalPhase 4
Collaborative Care Initiative, LLCPhase 4
Patient-Centered Outcomes Research InstituteN/A

See all TRILEPTAL clinical trials

Recent Litigation for TRILEPTAL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Supernus Pharmaceuticals, Inc v. Actavis Inc.2016-02-24

See all TRILEPTAL litigation

Pharmacology for TRILEPTAL
Synonyms for TRILEPTAL
10-oxo-10,11-dihydro-5H-dibenz(b,f)azepin-5-carboxamide
10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide
10-Oxo-10,11-dihydro-5H-dibenzo[b,f]azepine-5-carboxamide #
10,11-Dihydro-10-oxo-5H-debenz(b,f)azepine-5-carboxamide
10,11-Dihydro-10-oxo-5H-dibenz(b,f)azepine-5-carboxamide
10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepin-5-carbonsaeureamid
10,11-Dihydro-10-oxo-5H-dibenz[b,f]azepine-5-carboxamide
10,11-Dihydro-10-oxo-5h-dibenz[b,f]azepine-5-carboxamide; Oxacarbazepine
10,11-Dihydro-10-oxo-5H-dibenzo(Z)[b,f]azepine-5-carboxamide
10,11-Dihydro-10-oxo-5H-dibenzo[b,f]azepine-5-carboxamide
28721-07-5
5-carbamoyl-10-oxo-10,11-dihydro-5H-dibenz[b,f]azepine
5-oxo-6H-benzo[b][1]benzazepine-11-carboxamide
5H-Dibenz(b,f)azepine-5-carboxamide, 10,11-dihydro-10-oxo-
5H-Dibenz[b,f]azepine-5-carboxamide, 10,11-dihydro-10-oxo-
721O075
9-oxo-2-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaene-2-carboxamide
9-oxo-2-azatricyclo[9.4.0.0;{3,8}]pentadeca-1(11),3(8),4,6,12,14-hexaene-2-carboxamide
AB0012847
AB00393017_15
AB00393017_16
AB00393017-12
AB00393017-14
AB1004555
AC-3483
AC1L1RCU
AC1Q6NA8
AKOS005516529
AM20040094
AN-6739
API0003702
BB_SC-01874
BBL010789
BC204104
BCP28260
BDBM34179
BG0593
BIDD:GT0078
BRD-K04196797-001-12-9
BSPBio_003457
C-15585
C07492
CAS-28721-07-5
CC-33410
CCG-39509
CHEBI:7824
CHEMBL1068
cid_34312
CPD000048684
CS-1869
CTRLABGOLIVAIY-UHFFFAOYSA-N
D00533
DB00776
DSSTox_CID_25703
DSSTox_GSID_45703
DSSTox_RID_81075
DTXSID0045703
EINECS 249-188-8
EN300-123538
Epilexter
Epliga
FT-0630543
GP 47680
GP-47680
GTPL7254
HMS1922H17
HMS2051O04
HMS2090F13
HMS2093E10
HMS2231B12
HMS3369J22
HMS3393O04
HMS3657O11
HMS3713I10
HSDB 7524
HY-B0114
I06-0072
J10384
KBio2_002155
KBio2_004723
KBio2_007291
KBio3_002677
KBioGR_001248
KBioSS_002155
KIN-493
KS-5197
LS-60365
MCULE-9100100302
MFCD00865307
MLS000084586
MLS000759520
MLS001201742
MLS001424025
MLS006011855
MolPort-001-685-316
NC00088
NCGC00065934-02
NCGC00065934-03
NCGC00065934-04
NCGC00065934-05
NCGC00065934-06
NSC-758693
NSC758693
O0363
OCBZ
Opera_ID_818
Oxacarbazepine
Oxcarbamazepine
Oxcarbazepime
Oxcarbazepin
Oxcarbazepina
Oxcarbazepina [INN-Spanish]
OXCARBAZEPINE
Oxcarbazepine (JAN/USAN/INN)
Oxcarbazepine [INN]
Oxcarbazepine [USAN:USP:INN:BAN]
Oxcarbazepine solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
Oxcarbazepine-13C6 solution, 100 mug/mL in acetonitrile, ampule of 1 mL, certified reference material
Oxcarbazepine-d4
Oxcarbazepine, >=98% (HPLC), solid
Oxcarbazepine, analytical standard
Oxcarbazepine, European Pharmacopoeia (EP) Reference Standard
Oxcarbazepine, Pharmaceutical Secondary Standard; Certified Reference Material
Oxcarbazepine, United States Pharmacopeia (USP) Reference Standard
Oxcarbazepinum
Oxcarbazepinum [INN-Latin]
Oxtellar (TN)
Oxtellar XR
Pharmakon1600-01504243
regid866068
s1391
SAM001246754
SBI-0206772.P001
SC-16252
SCHEMBL35129
SMR000048684
SPBio_000345
Spectrum_001675
SPECTRUM1504243
Spectrum2_000483
Spectrum3_001669
Spectrum4_000634
Spectrum5_001869
SPN-804
SR-01000612612
SR-01000612612-4
SR-01000612612-6
STK594696
SW197468-3
Timox
Tox21_110983
Tox21_110983_1
Trileptal (TN)
UNII-VZI5B1W380
VZI5B1W380
W-107033
W-2542
ZB000586
ZINC4724

US Patents and Regulatory Information for TRILEPTAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285-001 May 25, 2001 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-003 Jan 14, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-001 Jan 14, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-002 Jan 14, 2000 AB RX Yes 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 TRILEPTAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRILEPTAL oxcarbazepine SUSPENSION;ORAL 021285-001 May 25, 2001   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-002 Jan 14, 2000   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-001 Jan 14, 2000   Start Trial   Start Trial
Novartis TRILEPTAL oxcarbazepine TABLET;ORAL 021014-003 Jan 14, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for TRILEPTAL
Drugname Dosage Strength RLD Date
➤ Subscribe Oral Suspension 300 mg/5 mL ➤ Subscribe   Start Trial
➤ Subscribe Tablets 150 mg, 300 mg and 600 mg ➤ Subscribe   Start Trial

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AstraZeneca
Baxter

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