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GABAPENTIN ENACARBIL - Generic Drug Details

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What are the generic drug 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

International Patents:	148
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	29
Suppliers / Packagers:	1
Bulk Api Vendors:	43
Clinical Trials:	28
Patent Applications:	117
Formulation / Manufacturing:	see details
DailyMed Link:	GABAPENTIN ENACARBIL at DailyMed

Recent Clinical Trials for GABAPENTIN ENACARBIL

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

Sponsor	Phase
National Institute on Aging (NIA)	Phase 4
University of Texas at Austin	Phase 4
University of Missouri-Columbia	N/A

See all GABAPENTIN ENACARBIL clinical trials

Pharmacology for GABAPENTIN ENACARBIL

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

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	022399-002	Dec 13, 2011		RX	Yes	No			Y
Arbor Pharms Llc	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No
Arbor Pharms Llc	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No			Y	Y
Arbor Pharms Llc	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No			Y	Y
Arbor Pharms Llc	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes
Arbor Pharms Llc	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes			Y	Y
Arbor Pharms Llc	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No

International Patents for GABAPENTIN ENACARBIL

Country	Patent Number	Estimated Expiration
Denmark	2275401
Portugal	1677767
Japan	5107576
Japan	4216713
European Patent Office	2085087
Japan	2005529941
Japan	2009051822