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Generated: March 21, 2019

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GABAPENTIN - Generic Drug Details

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What are the generic drug sources for gabapentin and what is the scope of gabapentin freedom to operate?

Gabapentin is the generic ingredient in four branded drugs marketed by Aci Healthcare Ltd, Actavis Elizabeth, Alkem, Amneal Pharms Ny, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Epic Pharma Llc, Hikma, Invagen Pharms, Jiangsu Hengrui Med, Marksans Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Ltd, Sun Pharm Industries, Taro Pharm, Teva Pharms, Watson Labs, Pfizer Pharms, Acella Pharms Llc, Amneal Pharms, Hi Tech Pharma, Taro, Tris Pharma Inc, Parke Davis, Alkem Labs Ltd, Glenmark Pharms Ltd, Hikma Pharms, Ivax Sub Teva Pharms, Lupin Ltd, Mylan Pharms Inc, Ranbaxy, Teva, Teva Pharms Usa, Zydus Pharms Usa Inc, Assertio, and Arbor Pharms Llc, and is included in fifty-four NDAs. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gabapentin has one hundred and six patent family members in forty-seven countries.

There are twenty-nine drug master file entries for gabapentin. One hundred and nine suppliers are listed for this compound. There are three tentative approvals for this compound.

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
Tentative approvals for GABAPENTIN
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up800MGTABLET;ORAL
➤ Sign Up➤ Sign Up600MGTABLET;ORAL
➤ Sign Up➤ Sign Up300MGCAPSULE;ORAL

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
Epic Pharma Llc GABAPENTIN gabapentin CAPSULE;ORAL 207099-002 Mar 24, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz GABAPENTIN gabapentin CAPSULE;ORAL 075539-002 Apr 6, 2005 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hikma GABAPENTIN gabapentin CAPSULE;ORAL 078150-002 Sep 25, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Elizabeth GABAPENTIN gabapentin CAPSULE;ORAL 075350-002 Sep 12, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for GABAPENTIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 ➤ Sign Up ➤ Sign Up
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-002 Dec 30, 1993 ➤ Sign Up ➤ Sign Up
Pfizer Pharms NEURONTIN gabapentin CAPSULE;ORAL 020235-001 Dec 30, 1993 ➤ Sign Up ➤ Sign Up
Assertio GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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