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:

Mallinckrodt
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AstraZeneca
Harvard Business School
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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

GABAPENTIN Drug Profile

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

Gabapentin is a drug marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cspc Ouyi, Epic Pharma Llc, Granules India Ltd, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro, Teva Pharms, Watson Labs, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, Tris Pharma Inc, Alkem Labs Ltd, Apotex Inc, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Rubicon, Teva, Teva Pharms Usa, and Zydus Pharms Usa Inc. and is included in forty-nine NDAs.

The generic ingredient in GABAPENTIN is gabapentin. There are twenty-nine drug master file entries for this compound. Eighty-two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the gabapentin profile page.

Drug patent expirations by year for GABAPENTIN
Drug Prices for GABAPENTIN

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Drug Sales Revenue Trends for GABAPENTIN

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Recent Clinical Trials for GABAPENTIN

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

SponsorPhase
Boston Medical CenterPhase 2
Seoul National University HospitalPhase 3
Fudan UniversityN/A

See all GABAPENTIN clinical trials

Recent Litigation for GABAPENTIN

Identify potential future generic entrants

District Court Litigation
Case NameDate
In re: Depomed, Inc.2015-12-30
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15
Purdue Pharma L.P. v. Depomed, Inc.2015-09-15

See all GABAPENTIN litigation

PTAB Litigation
PetitionerDate
Endo Pharmaceutical Inc.2014-04-17
Purdue Pharma L.P.2014-01-24

See all GABAPENTIN litigation

Pharmacology for GABAPENTIN
Synonyms for GABAPENTIN
(1-Aminomethyl-cyclohexyl)-acetic acid
[1-(AMINOMETHYL)CYCLOHEXYL]ACETIC ACID
1-(Aminomethyl)-cyclohexaneacetic acid
1-(Aminomethyl)-cyclohexaneacetic acid; Neurontin
1-(aminomethyl)cyclohexanacetic acid
1-(Aminomethyl)cyclohexaneacetic acid
1-(Aminomethyl)cyclohexaneaceticAcid
1-(aminomethyl)cyclohexyl-acetic Acid
1-aminomethyl cyclohexaneacetic acid
1-aminomethyl-1-cyclohexane-acetic acid
1-Aminomethyl-1cyclohexane-acetic acid
2-(1-(aminomethyl)cyclohexyl)acetic acid
2-[(aminomethyl)cyclohexyl]acetic acid
2-[1-(aminomethyl)cyclohexyl]acetic acid
42G963
60142-96-3
6CW7F3G59X
AB0068842
AB07485
AB1000455
AC-1485
AC1L1FYE
AC1Q53PH
Aclonium
ACT03340
AJ-08236
AKOS000280865
AM20070538
AN-14914
ANW-43124
BBL010794
BCP25698
BDBM50080153
BIDD:GT0656
BPBio1_000993
BR-35803
BRN 2359739
BSPBio_000901
C07018
C9H17NO2
CAS-60142-96-3
CCG-204671
CCRIS 7210
CHEBI:42797
CHEMBL940
CI 945
CI-945
CPD000058311
CS-1545
CTK3J2213
Cyclohexaneacetic acid, 1-(aminomethyl)-
D00332
DB00996
DDS-2003
DM-1796
DM-5689
DSSTox_CID_74
DSSTox_GSID_20074
DSSTox_RID_75350
DTXSID0020074
EINECS 262-076-3
EN300-52516
EU-0100582
Fanatrex
FT-0626586
G-154
G0318
Gabapen
Gabapentin (JAN/USAN/INN)
gabapentin (Neurontin)
Gabapentin [USAN:INN:BAN]
Gabapentin [USAN:USP:INN:BAN]
Gabapentin GR
Gabapentin solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Gabapentin solution, 10 mg/mL in methanol, ampule of 1 mL, certified reference material
Gabapentin-ER
Gabapentin, European Pharmacopoeia (EP) Reference Standard
Gabapentin, Pharmaceutical Secondary Standard; Certified Reference Material
Gabapentin, solid
Gabapentin, United States Pharmacopeia (USP) Reference Standard
GABAPENTIN; NEURONTIN
gabapentina
Gabapentine
Gabapentine [INN-French]
gabapentinium
Gabapentino
Gabapentino [INN-Spanish]
Gabapentino [Spanish]
Gabapentinum
Gabapentinum [INN-Latin]
Gabapetin
GBN
Go 3450
GOE 2450
GOE 3450
GOE 3450; CI 945; GO 3450
Goe-3450
Gralise
Gralise (TN)
GTPL5483
HMS1570N03
HMS2089J03
HMS2097N03
HMS2236O03
HMS3261F06
HMS3650A20
HMS3714N03
HSDB 7364
HY-A0057
I06-0677
KS-00000AF6
KS-1064
KSC492E1H
L000733
Lopac-G-154
Lopac0_000582
LP00582
LS-7194
M-2788
MCULE-5392848565
MFCD00865286
MFCD00865286 (98%)
MLS000069358
MolPort-000-883-862
NCGC00015466-01
NCGC00015466-02
NCGC00015466-03
NCGC00015466-04
NCGC00015466-05
NCGC00015466-06
NCGC00015466-07
NCGC00015466-08
NCGC00015466-09
NCGC00015466-11
NCGC00016891-01
NCGC00021545-02
NCGC00021545-04
NCGC00021545-05
NCGC00261267-01
Neuontin
Neurentin
Neurontin
Neurontin (TN)
Novo-Gabapentin
Novo-Gabapentine
NSC-742194
NSC742194
Prestwick_151
Prestwick0_000861
Prestwick1_000861
Prestwick2_000861
Prestwick3_000861
RTR-020802
s2133
SAM002548985
SAM002589946
SBB066157
SBI-0206904.P001
SC-12130
SCHEMBL8343
Sefelsa
Serada
SMR000058311
SPBio_002822
SR-01000000019
SR-01000000019-11
SR-01000000019-2
SR-01000000019-6
ST2410212
STK598009
SY005403
Therapentin-90
TL8003814
Tocris-0806
Tox21_110157
Tox21_110157_1
Tox21_500582
TR-020802
TRA0097671
UGJMXCAKCUNAIE-UHFFFAOYSA-N
UNII-6CW7F3G59X
Vultin
Z1258578343
ZINC4949
Paragraph IV (Patent) Challenges for GABAPENTIN
Tradename Dosage Ingredient NDA Submissiondate
GRALISE TABLET;ORAL gabapentin 022544 2011-10-31
NEURONTIN SOLUTION;ORAL gabapentin 021129
NEURONTIN CAPSULE;ORAL gabapentin 020235
NEURONTIN TABLET;ORAL gabapentin 020882

US Patents and Regulatory Information for GABAPENTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hi Tech Pharma GABAPENTIN gabapentin SOLUTION;ORAL 078974-001 Feb 18, 2011 AA RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc GABAPENTIN gabapentin TABLET;ORAL 090335-001 Jun 1, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz GABAPENTIN gabapentin CAPSULE;ORAL 075539-001 Apr 6, 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

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Medtronic
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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.