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GRALISE Drug Profile

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When do Gralise patents expire, and what generic alternatives are available?

Gralise is a drug marketed by Assertio and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in sixteen countries.

The generic ingredient in GRALISE is gabapentin. There are twenty-eight drug master file entries for this compound. One hundred and nine suppliers are listed for this compound. Additional details are available on the gabapentin profile page.

Summary for GRALISE

International Patents:	54
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	116
Clinical Trials:	9
Patent Applications:	4,551
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GRALISE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GRALISE
DailyMed Link:	GRALISE at DailyMed

Pharmacology for GRALISE

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

Synonyms for GRALISE

(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

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 (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

US Patents and Regulatory Information for GRALISE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Assertio	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	BX	RX	Yes	Yes
Assertio	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	BX	RX	Yes	Yes			Y
Assertio	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011	BX	RX	Yes	Yes			Y
Assertio	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011	BX	RX	Yes	Yes			Y

Expired US Patents for GRALISE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Assertio	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011
Assertio	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011
Assertio	GRALISE	gabapentin	TABLET;ORAL	022544-002	Jan 28, 2011
Assertio	GRALISE	gabapentin	TABLET;ORAL	022544-001	Jan 28, 2011

Paragraph IV (Patent) Challenges for GRALISE

Drugname	Dosage	Strength	RLD	Date
	Tablets	300 mg and 600 mg

International Patents for GRALISE

Country	Document Number	Estimated Expiration
China	101484153
Japan	2005532985
European Patent Office	1439825
European Patent Office	2260832