Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Gabapentin enacarbil - Generic Drug Details

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

Gabapentin enacarbil is the generic ingredient in one branded drug marketed by Arbor Pharms Llc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Gabapentin enacarbil has one hundred and forty-eight patent family members in twenty-six countries.

There are twenty-nine drug master file entries for gabapentin enacarbil. One supplier is listed for this compound.

Summary for gabapentin enacarbil
Recent Clinical Trials for gabapentin enacarbil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Texas at AustinPhase 4
National Institute on Aging (NIA)Phase 4
The Cleveland ClinicN/A

See all gabapentin enacarbil clinical trials

Pharmacology for gabapentin enacarbil
Synonyms for gabapentin enacarbil
(1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid
{[(1-Isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-Cyclohexane Acetic Acid
{[(alpha-Isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-Cyclohexane Acetic Acid
{1-[({[1-(isobutyryloxy)ethoxy]carbonyl}amino)methyl]cyclohexyl}acetic acid
1-[[[[1-(2-Methyl-1-oxopropoxy)ethoxy]carbonyl]amino]methyl]cyclohexaneacetic acid
1-{[(alpha-Isobutanovloxyethoxy)carbonyl]aminomethyl}-1-Cyclohexane Acetic Acid
1-{[(alpha-Isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-Cyclohexane Acetic Acid
1-{[(alpha-isobutanoyloxyethoxy)carbonyl]aminomethyl}-1-cyclohexaneacetic acid
2-(1-((((1-(Isobutyryloxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid
2-(1-(((1-(isobutyryloxy)ethoxy)carbonyl)methyl)cyclohexyl)acetic acid
2-(1-(((1-(isobutyryloxy)ethoxy)carbonylamino)methyl)cyclohexyl)acetic acid
2-[1-[[[1-[(2-Methylpropanoyl)oxy]ethoxy]carbonylamino]methyl]cyclohexyl]acetic acid
2-[1-[[1-(2-methylpropanoyloxy)ethoxycarbonylamino]methyl]cyclohexyl]acetic acid
296G729
3687AH
478296-72-9
791632-57-0
A20372
AC-27644
ACN-028536
AKOS025290727
AN-16701
API0008802
AS-35192
ASP 8825
ASP-8825
ASP8825
BCP12845
CHEBI:68840
CHEMBL1628502
CS-1698
Cyclohexaneacetic acid, 1-((((1-(2-methyl-1-oxopropoxy)ethoxy)carbonyl)amino)methyl)-
Cyclohexaneacetic acid,1-[[[[1-(2-methyl-1-oxopropoxy)ethoxy]carbonyl]amino]methyl]-
D09539
DB08872
FT-0753836
Gabapentin enacarbil (JAN/USAN/INN)
Gabapentin enacarbil [USAN:INN]
gabapentina enacarbilo
gabapentine enacarbil
gabapentinum enacarbilum
GSK 1838262
GSK-1838262
GSK1838262
GTPL7560
Horizant
Horizant (TN)
Horizant, Regnite
Horizant|||Regnite|||XP 13512
HY-16216
PB32822
Q-1947
Regnite
SCHEMBL25455
Solzira
TZDUHAJSIBHXDL-UHFFFAOYSA-N
XP 13512
XP-053
XP-13512
XP13512
Paragraph IV (Patent) Challenges for GABAPENTIN ENACARBIL
Tradename Dosage Ingredient NDA Submissiondate
HORIZANT TABLET, EXTENDED RELEASE;ORAL gabapentin enacarbil 022399 2019-04-29

US Patents and Regulatory Information for gabapentin enacarbil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-001 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-002 Dec 13, 2011 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-001 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-001 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-001 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-001 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Medtronic
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Boehringer Ingelheim
Colorcon

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.