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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 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, 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, Mylan Pharms Inc, Ranbaxy, Teva, Teva Pharms Usa, Zydus Pharms Usa Inc, Depomed Inc, and Arbor Pharms Llc, and is included in fifty-two 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-eight drug master file entries for gabapentin. One hundred and ten 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:	38
NDAs:	52
Drug Master File Entries:	28
Suppliers / Packagers:	110
Bulk Api Vendors:	112
Clinical Trials:	330
Patent Applications:	6,666
Formulation / Manufacturing:	see details
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
		600MG	TABLET;ORAL
		800MG	TABLET;ORAL
		400MG	CAPSULE;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
Cspc Ouyi Pharm Co	GABAPENTIN	gabapentin	TABLET;ORAL	207057-002	Oct 26, 2017	AB	RX	No	No
Teva Pharms	GABAPENTIN	gabapentin	CAPSULE;ORAL	075435-003	Oct 8, 2004	AB	RX	No	No
Sciegen Pharms Inc	GABAPENTIN	gabapentin	CAPSULE;ORAL	204989-002	Feb 18, 2016	AB	RX	No	No
Aurobindo Pharma Ltd	GABAPENTIN	gabapentin	CAPSULE;ORAL	078787-001	Jan 31, 2008	AB	RX	No	No

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Expired US Patents for gabapentin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Pharms	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-003	Dec 30, 1993
Parke Davis	NEURONTIN	gabapentin	SOLUTION;ORAL	021129-001	Mar 2, 2000
Pfizer Pharms	NEURONTIN	gabapentin	CAPSULE;ORAL	020235-001	Dec 30, 1993
Pfizer Pharms	NEURONTIN	gabapentin	TABLET;ORAL	020882-001	Oct 9, 1998

Non-Orange Book US Patents for gabapentin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,612,112	Methods of treatment using a gastric retained gabapentin dosage
8,119,166	Methods of treatment using a gastric retained gabapentin dosage
8,231,905	Gastric retained gabapentin dosage form
8,333,991	Gastric retained gabapentin dosage form

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International Patents for gabapentin

Country	Document Number	Estimated Expiration
Slovakia	14112003
Japan	2013224324
African Regional IP Organization (ARIPO)	1815
South Korea	100716756