Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 8, 2019

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Tetrabenazine - Generic Drug Details

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What are the generic drug sources for tetrabenazine and what is the scope of patent protection?

Tetrabenazine is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Bionpharma Inc, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, Mylan, Sun Pharm, West-ward Pharms Int, and Valeant Pharms North, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for tetrabenazine. Ten suppliers are listed for this compound.

Drug Prices for tetrabenazine

See drug prices for tetrabenazine

Recent Clinical Trials for tetrabenazine

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

SponsorPhase
Kirk A. FreyPhase 1
Adeptio PharmaceuticalsPhase 1
Dr. Reddy's Laboratories LimitedPhase 1

See all tetrabenazine clinical trials

Pharmacology for tetrabenazine
Medical Subject Heading (MeSH) Categories for tetrabenazine
Synonyms for tetrabenazine
1,2,4,6,7,11b-Hexahydro-3-isobutyl-9,10-dimethoxy-2H-benzo[a]quinolizin-2-one
1,3,4,6,7,11b-Hexahydro-3-isobutyl-9,10-dimethoxy-2H-benzo(a)quinolizin-2-one
1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-Benzo[a]quinolizin-2-one
1,4,6,7,11b-Hexahydro-3-isobutyl-9,10-dimethoxy-2H-benzo[a]quinolizin-2-one
2-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7-hexahydro-11bH-benzo[a]quinolizine
2-Oxo-3-isobutyl-9,10-dimethoxy-1,2,3,4,6,7,11b-hexahydro-2H-benzo(a)quinolizine
2-Oxo-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11-beta-hexahydro-2H-benzoquinolizine
2-oxo-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-benzoquinolizine
2-Oxo-3-isobutyl-9,2,3,4,6,7-hexahydro-11bH-benzo[a]quinolizine
2-Oxo-3-isobutyl-9,3,4,6,7,11.beta.-hexahydro-2H-benzoquinolizine
2,3-dimethoxy-9-(2-methylpropyl)-5,6,7,11a-tetrahydropiperidino[2,1-a]isoquino lin-10-one
2H-Benzo(a)quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-3-isobutyl-9,10-dimethoxy-
2H-Benzo(a)quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-
2H-Benzo[a]quinolizin-2-one, 1,3,4,6,7, 11b-hexahydro-3-isobutyl-9,10-dimethoxy-,
2H-Benzo[a]quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-
2h-benzo[a]quinolizin-2-one,1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-,(3r,11br)-rel
2H-Benzo[a]quinolizin-2-one,1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-,(3R,11bR)-rel-
2H-Benzo[a]quinolizin-2-one,3,4,6,7,11b-hexahydro-3-isobutyl-9,10-dimethoxy-
2H-Benzo[a]quinolizin-2-one,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-
3-isobutyl-9-,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-benzo[a]quinolizin-2-one
3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one
3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one #
3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-pyrido[2,1-a]isoquinolin-2-one
3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydrobenzo[a]quinolizin-2-one
3-isobutyl-9,10-dimethoxy-3,4,6,7-tetrahydro-1H-pyrido[2,1-a]isoquinolin-2(11bH)-one
58-46-8
718635-93-9
9,10-Dimethoxy-1,3,4,6,7,11b-hexahydro-3-isobutyl-2H-benzo[a]quinolizin-2-one
9,10-dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one
9,10-dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydrobenzo[a]quinolizin-2-one
9,10-dimethoxy-3-(2-methylpropyl)-1H,2H,3H,4H,6H,7H,11bH-pyrido[2,1-a]isoquinolin-2-one
9,10-dimethoxy-3-isobutyl-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one
A2708/0115225
AB0073774
AB2000294
AC1L1LMF
ACT06890
AI3-52046
AK141500
AKOS001681311
AKOS016347602
AN-41756
API0004368
AS-35785
AX8281672
BC201335
BCP24156
BDBM50017701
BN0515
BRD-A47564106-001-01-8
BRN 0040090
C11168
CAS-58-46-8
CCG-118217
CHEBI:64028
CHEMBL117785
CS-5700
CTK8E8809
D08575
DB04844
DSSTox_CID_22614
DSSTox_GSID_42614
DSSTox_RID_80059
DTXSID0042614
EINECS 200-383-6
EX-A2361
FT-0674921
FT-0700948
GTPL4834
HMS1540E17
HMS2966E06
HMS3263I14
HMS3430F03
HY-B0590A
KB-3357051
KS-00001F7Q
LP01086
LS-40294
MCULE-5822627411
MFCD08461052
MKJIEFSOBYUXJB-UHFFFAOYSA-N
MLS001249426
MLS001249497
MLS003106727
MolPort-002-712-672
NCGC00160421-01
NCGC00160421-02
NCGC00160421-03
NCGC00261771-01
Nitoman
Nitoman (TN)
Nitoman;Xenazine
NSC 169886
NSC-169886
NSC-172187
NSC169886
NSC172187
Oprea1_264344
PB21652
Q-2641
Revocon
Ro 1-9569
Ro 1-9569/12
Ro-19569
Rubigen
s1789
SBB018797
SC-20416
SCHEMBL62026
SMR000718664
SR-01000833864
SR-01000833864-4
ST028814
STK678061
TC-062470
tetra Benazin
Tetrabenazin
Tetrabenazina
Tetrabenazina [INN-Spanish]
Tetrabenazine (JAN/INN)
Tetrabenazine (Nitoman, Xenazine)
Tetrabenazine (Racemate)
Tetrabenazine [INN:BAN]
Tetrabenazine Racemate
Tetrabenazine, racemic mixture|||9,10-Dimethoxy-1,3,4,6,7,11b-hexahydro-3-isobutyl-2H-benzo[a]quinolizin-2-one
Tetrabenazine(Racemate)
Tetrabenazinum
Tetrabenazinum [INN-Latin]
Tetrabenzaine
Tetrabenzine
TimTec1_002217
TL8005032
Tox21_111803
Tox21_111803_1
Tox21_501086
WLN: T B666 DV GNTT&J E1Y1&1 LO1 MO1
Xenazine
Xenazine (TN)
Z1563146114
Z3433

US Patents and Regulatory Information for tetrabenazine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd V TETRABENAZINE tetrabenazine TABLET;ORAL 204574-001 Feb 3, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Bionpharma Inc TETRABENAZINE tetrabenazine TABLET;ORAL 208826-001 Dec 18, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int TETRABENAZINE tetrabenazine TABLET;ORAL 209739-002 Apr 8, 2019 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

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