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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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Colorcon
Baxter
McKinsey
Mallinckrodt

Last Updated: December 12, 2019

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Tiagabine hydrochloride - Generic Drug Details

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

Tiagabine hydrochloride is the generic ingredient in two branded drugs marketed by Cephalon, Amneal Pharms Co, Sun Pharm Inds, and Wilshire Pharms Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for tiagabine hydrochloride. Five suppliers are listed for this compound.

Recent Clinical Trials for tiagabine hydrochloride

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

SponsorPhase
Eisai Inc.Phase 4
Mid-Atlantic Epilepsy and Sleep Center, LLCPhase 4
Brigham and Women's HospitalPhase 2

See all tiagabine hydrochloride clinical trials

Recent Litigation for tiagabine hydrochloride

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 tiagabine hydrochloride litigation

Pharmacology for tiagabine hydrochloride
Synonyms for tiagabine 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 hydrochloride
(-)-(R)-1-[4,4-bis(3-methyl-2-thienyl)-3-butenyl]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 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 hydrochloride
(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 hydrochloride
(3R)-1-[4,4-bis(3-methylthiophen-2-yl)but-3-enyl]piperidine-3-carboxylic acid;hydrochloride
(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 hydrochloride
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)-, hydrochloride, (R)-
4CH-019728
A-70569
Abbott 70569.HCl
Abbott-70569.1
ABBOTT-70569.HCL
ABT 569
ABT-569
AC1L3LR1
AK155448
AKOS024258856
AN-31388
API0004405
AX8154082
BG0438
C20H25NO2S2.HCl
C20H26ClNO2S2
CAS-145821-59-6
CCG-100885
CEP-6671
CHEBI:85388
CHEMBL1695
CPD000469176
CS-2937
D02097
DQH6T6D8OY
DSSTox_CID_24218
DSSTox_GSID_44218
DSSTox_RID_80125
DTXSID2044218
EN300-221591
FT-0675216
Gabitril
Gabitril (TN)
Gabitril hydrochloride
H03T543
HY-B0696A
J-008159
KB-308664
KS-00000H6B
KS-1217
LS-173258
MFCD07369025
MLS001401367
MolPort-006-069-142
NC00135
NCGC00164626-01
NCGC00164626-02
NN-301
NNC-05-0328
NO-05-0328
NO-328
NO050328 hydrochloride
NO328 hydrochloride
s4661
SAM001246625
SCHEMBL41860
SMR000469176
ST2402069
TGB hydrochloride
Tiabex
Tiagabine (hydrochloride)
TIAGABINE HCl
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
Tox21_112245
Tox21_112245_1
UNII-DQH6T6D8OY
VC30712
YUKARLAABCGMCN-PKLMIRHRSA-N
Z2216208631
Paragraph IV (Patent) Challenges for TIAGABINE HYDROCHLORIDE
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 tiagabine hydrochloride

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 020646-002 Sep 30, 1997 AB RX Yes No   Start Trial   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-001 Sep 30, 1997 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Amneal Pharms Co TIAGABINE HYDROCHLORIDE tiagabine hydrochloride TABLET;ORAL 208181-001 Dec 8, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-006 Nov 29, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds TIAGABINE HYDROCHLORIDE tiagabine hydrochloride TABLET;ORAL 077555-001 Nov 4, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co TIAGABINE HYDROCHLORIDE tiagabine hydrochloride TABLET;ORAL 208181-004 Dec 8, 2017 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 tiagabine hydrochloride

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
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-003 Sep 30, 1997   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-002 Sep 30, 1997   Start Trial   Start Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-005 Apr 16, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Boehringer Ingelheim
Harvard Business School
Express Scripts
McKesson

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