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Last Updated: February 18, 2020

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OXTELLAR XR Drug Profile


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Which patents cover Oxtellar Xr, and what generic alternatives are available?

Oxtellar Xr is a drug marketed by Supernus Pharms and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has fourteen patent family members in ten countries.

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

US ANDA Litigation and Generic Entry Outlook for Oxtellar Xr

A generic version of OXTELLAR XR was approved as oxcarbazepine by GLENMARK PHARMS LTD on October 9th, 2007.

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Drug patent expirations by year for OXTELLAR XR
Drug Prices for OXTELLAR XR

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Recent Clinical Trials for OXTELLAR XR

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SponsorPhase
Collaborative Care Initiative, LLCPhase 4
Dauten Family Center for Bipolar Treatment Innovation, Massachusetts Gen HospitalPhase 4
Supernus Pharmaceuticals, Inc.Phase 3

See all OXTELLAR XR clinical trials

Recent Litigation for OXTELLAR XR

Identify potential future generic entrants

District Court Litigation
Case NameDate
Supernus Pharmaceuticals, Inc v. Actavis Inc.2016-02-24
SUPERNUS PHARMACEUTICALS, INC. v. ACTAVIS INC.2015-04-07
SUPERNUS PHARMACEUTICALS, INC. v. TWI PHARMACEUTICALS, INC.2015-01-16

See all OXTELLAR XR litigation

Pharmacology for OXTELLAR XR
Synonyms for OXTELLAR XR
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)
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
Trileptal (TN)
UNII-VZI5B1W380
VZI5B1W380
W-107033
W-2542
ZB000586
ZINC4724
Paragraph IV (Patent) Challenges for OXTELLAR XR
Tradename Dosage Ingredient NDA Submissiondate
OXTELLAR XR TABLET, EXTENDED RELEASE;ORAL oxcarbazepine 202810 2013-04-12
OXTELLAR XR TABLET, EXTENDED RELEASE;ORAL oxcarbazepine 202810 2013-03-20

US Patents and Regulatory Information for OXTELLAR XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Supernus Pharms OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810-001 Oct 19, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Supernus Pharms OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810-002 Oct 19, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Supernus Pharms OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810-003 Oct 19, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Supernus Pharms OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810-001 Oct 19, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Supernus Pharms OXTELLAR XR oxcarbazepine TABLET, EXTENDED RELEASE;ORAL 202810-001 Oct 19, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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