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Gabapentin - Generic Drug Details

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

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.

Summary for gabapentin

International Patents:	106
US Patents:	14
Tradenames:	4
Applicants:	40
NDAs:	54
Drug Master File Entries:	29
Suppliers / Packagers:	109
Bulk Api Vendors:	116
Clinical Trials:	365
Patent Applications:	6,698
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for gabapentin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for gabapentin
DailyMed Link:	gabapentin at DailyMed

Pharmacology for gabapentin

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Synonyms for gabapentin

(1-Aminomethyl-cyclohexyl)-acetic acid
[1-(AMINOMETHYL)CYCLOHEXYL]ACETIC ACID
1-(AMINOETHYL)CYCLOHEXANEACETIC 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
AK-35803
AKOS000280865
AM010472
AM20070538
AN-14914
ANW-43124
Apo-Gabapentin
Apotex brand of gabapentin
Aventis brand of gabapentin
BB_SC-1512
BBL010794
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
D0J0ZS
DB00996
DDS-2003
DM-1796
DM-5689
DR000202
DSSTox_CID_74
DSSTox_GSID_20074
DSSTox_RID_75350
DTXSID0020074
EINECS 262-076-3
EN300-52516
EU-0100582
Fanatrex
FT-0626586
G-154
G0318
gabamox
Gabapen
Gabapentin (JAN/USAN/INN)
gabapentin (Neurontin)
Gabapentin [USAN:INN:BAN]
Gabapentin [USAN:USP:INN:BAN]
Gabapentin GR
Gabapentin Hexal
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 Stada
Gabapentin-ER
Gabapentin-ratiopharm
Gabapentin, European Pharmacopoeia (EP) Reference Standard
Gabapentin, pharmaceutical secondary standard; traceable to USP
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
GABAPETINE
Gabarone
GBN
Go 3450
GOE 2450
GOE 3450
Goe-3450
Gralise
Gralise (TN)
GTPL5483
Hexal brand of gabapentin
HMS1570N03
HMS2089J03
HMS2097N03
HMS2236O03
HMS3261F06
HMS3650A20
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
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
Novopharm brand of gabapentin
NSC-742194
NSC742194
OR207423
Parke Davis brand of gabapentin
Pfizer brand of gabapentin
Pharmascience brand of gabapentin
PMS-Gabapentin
Prestwick_151
Prestwick0_000861
Prestwick1_000861
Prestwick2_000861
Prestwick3_000861
ratiopharm brand of gabapentin
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
ST2410212
Stadapharm brand of gabapentin
STK598009
Therapentin-90
TL8003814
Tocris-0806
Tox21_110157
Tox21_110157_1
Tox21_500582
TR-020802
TRA0097671
UGJMXCAKCUNAIE-UHFFFAOYSA-N
UNII-6CW7F3G59X
Vultin
Warner-Lambert brand of gabapentin
Z1258578343
ZINC4949

Tentative approvals for GABAPENTIN

Applicant	Application No.	Strength	Dosage Form
➤ Sign Up	➤ Sign Up	800MG	TABLET;ORAL
➤ Sign Up	➤ Sign Up	600MG	TABLET;ORAL
➤ Sign Up	➤ Sign Up	400MG	CAPSULE;ORAL

US Patents and Regulatory Information for gabapentin

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Ltd	GABAPENTIN	gabapentin	TABLET;ORAL	077662-001	Aug 18, 2006	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Ranbaxy	GABAPENTIN	gabapentin	TABLET;ORAL	076605-002	Sep 14, 2005		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Ivax Sub Teva Pharms	GABAPENTIN	gabapentin	TABLET;ORAL	076017-005	Apr 29, 2005	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Assertio	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	BX	RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Marksans Pharma	GABAPENTIN	gabapentin	CAPSULE;ORAL	090007-001	Jul 21, 2011	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Parke Davis	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000	AA	RX	Yes	Yes	➤ Sign Up	➤ Sign Up			Y	➤ Sign Up
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 gabapentin

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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	020235-003	Dec 30, 1993	➤ Sign Up	➤ Sign Up
Assertio	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	➤ Sign Up	➤ Sign Up
Pfizer Pharms	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-001	Dec 30, 1993	➤ Sign Up	➤ Sign Up
Pfizer Pharms	NEURONTIN	gabapentin	TABLET;ORAL	020882-001	Oct 9, 1998	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

International Patents for gabapentin

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Country	Document Number	Estimated Expiration
Ukraine	75138	➤ Sign Up
European Patent Office	1976503	➤ Sign Up
Canada	2635466	➤ Sign Up
Japan	2013006863	➤ Sign Up
Mexico	PA03009392	➤ Sign Up
Argentina	033922	➤ Sign Up
Country	Document Number	Estimated Expiration