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

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
Baxter
Express Scripts
Mallinckrodt
Boehringer Ingelheim

Last Updated: December 12, 2019

DrugPatentWatch Database Preview

GABITRIL Drug Profile

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

Which patents cover Gabitril, and what generic alternatives are available?

Gabitril is a drug marketed by Cephalon and is included in one NDA.

The generic ingredient in GABITRIL is tiagabine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Gabitril

A generic version of GABITRIL was launched as tiagabine hydrochloride by SUN PHARM INDS on December 12th, 2019.

Drug patent expirations by year for GABITRIL
Drug Prices for GABITRIL

See drug prices for GABITRIL

Recent Clinical Trials for GABITRIL

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

SponsorPhase
Brigham and Women's HospitalPhase 2
Rajesh NarendranPhase 1
CephalonPhase 3

See all GABITRIL clinical trials

Recent Litigation for GABITRIL

Identify potential future generic entrants

District Court Litigation
Case NameDate
CEPHALON, INC. v. SUN PHARMACEUTICAL INDUSTRIES, INC.2011-09-21
CEPHALON, INC. v. SUN PHARMACEUTICAL INDUSTRIES, INC.

See all GABITRIL litigation

Synonyms for GABITRIL
(-)-(R)-1-(4,4-Bis(3-methyl-2-thienyl)-3-butenyl)nipecotic acid
(-)-(R)-1-(4,4-bis(3-methyl-2-thienyl)-3-butenyl)nipecotic acid hydrochloride
(-)-(R)-1-(4,4-Bis(3-methyl-2-thienyl)-3-butenyl)nipecotic acid, hydrochloride
(-)-(R)-1-[4,4-Bis(3- methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride
(-)-(r)-1-[4,4-bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid
(-)-(R)-1-[4,4-bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid hydrochloride
(-)-(R)-1-[4,4-Bis(3-methyl-2-thienyl)-3butenyl]nipecotic acid hydrochloride
(3R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-buten-1-yl]-3-piperidinecarboxylic acid hydrochloride
(3R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]-3-piperidinecarboxylic Acid Hydrochloride
(3R)-1-[4,4-bis(3-methyl-2-thienyl)but-3-en-1-yl]-3-carboxypiperidinium chloride
(3R)-1-[4,4-bis(3-methyl-2-thienyl)but-3-en-1-yl]piperidine-3-carboxylic acid
(3R)-1-[4,4-bis(3-methyl-2-thienyl)but-3-en-1-yl]piperidine-3-carboxylic acid hydrochloride
(3R)-1-[4,4-bis(3-methyl-2-thienyl)but-3-en-1-yl]piperidine-3-carboxylic acid monohydrochloride
(3R)-1-[4,4-bis(3-methyl-2-thienyl)but-3-enyl]piperidine-3-carboxylic acid
(3R)-1-[4,4-bis(3-methyl-2-thienyl)but-3-enyl]piperidine-3-carboxylic acid hydrochloride
(3R)-1-[4,4-bis(3-methylthiophen-2-yl)but-3-en-1-yl]piperidine-3-carboxylic acid
(3R)-1-[4,4-bis(3-methylthiophen-2-yl)but-3-en-1-yl]piperidine-3-carboxylic acid hydrochloride
(3R)-1-[4,4-bis(3-methylthiophen-2-yl)but-3-enyl]piperidine-3-carboxylic acid
(3R)-1-[4,4-bis(3-methylthiophen-2-yl)but-3-enyl]piperidine-3-carboxylic acid hydrochloride
(3R)-1-[4,4-bis(3-methylthiophen-2-yl)but-3-enyl]piperidine-3-carboxylic acid;hydrochloride
(R)-(-)-1-[4,4-bis(3-methyl-2-thienyl)-3-butenyl]nipecotic acid
(R)-1-(4,4-Bis(3-methylthiophen-2-yl)but-3-en-1-yl)piperidine-3-carboxylic acid
(r)-1-(4,4-bis(3-methylthiophen-2-yl)but-3-en-1-yl)piperidine-3-carboxylic acid hydrochloride
(R)-1-(4,4-bis(3-methylthiophen-2-yl)but-3-enyl)piperidine-3-carboxylic acid
(R)-1-(4,4-bis(3-methylthiophen-2-yl)but-3-enyl)piperidine-3-carboxylic acid hydrochloride
(R)-1-[4,4-Bis-(3-methyl-thiophen-2-yl)-but-3-enyl]-piperidine-3-carboxylic acid
(R)-1-[4,4-Bis-(3-methyl-thiophen-2-yl)-but-3-enyl]-piperidine-3-carboxylic acid; hydrochloride
(r)-n-[4,4-bis(3-methyl-2-thienyl)but-3-en-1-yl]nipecotic acid
(R)-Tiagabine
(S)-1-(4,4-bis(3-methylthiophen-2-yl)but-3-enyl)piperidine-3-carboxylic acid
[3H]tiagabine
1-[4,4-Bis-(3-methyl-4,5-dihydro-thiophen-2-yl)-but-3-enyl]-piperidine-3-carboxylic acid
1-[4,4-Bis-(3-methyl-thiophen-2-yl)-but-3-enyl]-piperidine-3-carboxylic acid; hydrochloride
103T543
115103-54-3
145821-59-6
3-Piperidinecarboxylic acid, 1-(4,4-bis(3-methyl-2-thienyl)-3-buten-yl)-, hydrochloride, (R)-
3-Piperidinecarboxylic acid, 1-(4,4-bis(3-methyl-2-thienyl)-3-butenyl)-, (R)-
3-Piperidinecarboxylic acid, 1-(4,4-bis(3-methyl-2-thienyl)-3-butenyl)-, hydrochloride, (R)-
4CH-019728
A-70569
A-70569-1
Abbott 70569.HCl
Abbott-70569
ABBOTT-70569-1
Abbott-70569.1
ABBOTT-70569.HCL
ABT 569
ABT-569
AC-7048
AC1L1TNE
AC1L3LR1
AC1Q5R43
AJ-45795
AK155448
AKOS016011165
AKOS024258856
AN-31388
AN-9377
API0004405
API0009125
AX8154081
AX8154082
BDBM50039251
BDBM50368628
BG0438
BIDD:GT0018
BRD-K60160658-003-08-8
C-21249
C07503
C20H25NO2S2
C20H25NO2S2.HCl
C20H26ClNO2S2
CAS-145821-59-6
CC-35052
CCG-100885
CEP-6671
CHEBI:85388
CHEBI:9586
CHEMBL1027
CHEMBL1695
CPD000469176
CS-2936
CS-2937
D02097
D08588
DB00906
DQH6T6D8OY
DSSTox_CID_24218
DSSTox_GSID_44218
DSSTox_RID_80125
DTXSID2044218
DTXSID5023663
EN300-221591
EN300-222195
FT-0631075
FT-0675216
Gabatril
Gabitril (TN)
Gabitril hydrochloride
GTPL4685
GTPL4818
H03T543
HSDB 7527
HY-B0696
HY-B0696A
J-008159
KB-209487
KB-308664
KS-00000H6B
KS-1217
LS-114651
LS-173258
MFCD07369025
MLS001401367
MolPort-006-069-142
MolPort-006-167-658
NC00135
NCGC00164626-01
NCGC00164626-02
NN-301
NNC-05-0328
NO 050328
NO 328
NO 329
NO-05-0328
NO-328
NO-329
NO050328
NO050328 hydrochloride
NO050328;NO328;TGB
NO328
NO328 hydrochloride
PBJUNZJWGZTSKL-MRXNPFEDSA-N
s4661
s4675
SAM001246625
SCHEMBL34653
SCHEMBL41860
SMR000469176
ST2402069
TGB
TGB hydrochloride
Tiabex
Tiagabina
Tiagabina [INN-Spanish]
tiagabine
Tiagabine (hydrochloride)
Tiagabine (INN)
Tiagabine [INN:BAN]
Tiagabine [INN]
TIAGABINE HCl
Tiagabine hydrochloride
Tiagabine hydrochloride (USP)
Tiagabine hydrochloride [USAN:USP]
Tiagabine hydrochloride [USAN]
Tiagabine Hydrochloride 1.0 mg/ml in Methanol (as free base)
Tiagabine hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Tiagabine hydrochloride, >=98% (HPLC)
Tiagabine hydrochloride, 98+%
tiagabine monohydrochloride
Tiagabinum
Tiagabinum [INN-Latin]
Tox21_112245
Tox21_112245_1
UNII-DQH6T6D8OY
UNII-Z80I64HMNP
VC30712
YUKARLAABCGMCN-PKLMIRHRSA-N
Z2216208631
Z80I64HMNP
ZINC3831531
Paragraph IV (Patent) Challenges for GABITRIL
Tradename Dosage Ingredient NDA Submissiondate
GABITRIL TABLET;ORAL tiagabine hydrochloride 020646 2014-01-24
GABITRIL TABLET;ORAL tiagabine hydrochloride 020646 2005-02-01

US Patents and Regulatory Information for GABITRIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-005 Apr 16, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-003 Sep 30, 1997 AB RX Yes No   Start Trial   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-007 Nov 29, 2005 DISCN 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 GABITRIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-004 Sep 30, 1997   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-004 Sep 30, 1997   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-001 Sep 30, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Serving leading biopharmaceutical companies globally:

Merck
Moodys
AstraZeneca
Johnson and Johnson
Boehringer Ingelheim
Dow

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.