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Generated: September 25, 2018

DrugPatentWatch Database Preview

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.

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

Summary for GRALISE
US Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 111
Clinical Trials: 7
Patent Applications: 4,562
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
Drug patent expirations by year for GRALISE
Pharmacology for GRALISE
Drug ClassAnti-epileptic Agent
Physiological EffectDecreased 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

Glossary
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 ➤ 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
Assertio GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 BX RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Assertio GRALISE gabapentin TABLET;ORAL 022544-002 Jan 28, 2011 BX RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Assertio GRALISE gabapentin TABLET;ORAL 022544-001 Jan 28, 2011 BX RX Yes Yes ➤ 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 GRALISE

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

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Paragraph IV (Patent) Challenges for GRALISE
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 300 mg and 600 mg ➤ Subscribe ➤ Sign Up

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Accenture
Dow
Fuji
Chinese Patent Office
Baxter
Healthtrust
Federal Trade Commission
Cipla

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.

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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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