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Gabapentin enacarbil - Generic Drug Details

What are the generic drug sources for gabapentin enacarbil and what is the scope of gabapentin enacarbil patent protection?
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-seven patent family members in twenty-five countries.

There are twenty-eight drug master file entries for gabapentin enacarbil. Two suppliers are listed for this compound.

Summary for gabapentin enacarbil

International Patents:	147
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	28
Suppliers / Packagers:	2
Bulk Api Vendors:	32
Clinical Trials:	331
Patent Applications:	115
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	gabapentin enacarbil at DailyMed

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
AK170416
AKOS025290727
AN-16701
API0008802
ASP-8825
ASP8825
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]-
D05KBU
D09539
DB08872
FT-0753836
Gabapentin enacarbil (JAN/USAN/INN)
Gabapentin enacarbil [USAN:INN]
Gabapentin-XP
gabapentina enacarbilo
gabapentine enacarbil
Gabapentinenacarbil
gabapentinum enacarbilum
GSK 1838262
GSK-1838262
GSK1838262
GTPL7560
Horizant
Horizant (TN)
Horizant, Regnite
Horizant\|\|\|Regnite\|\|\|XP 13512
HY-16216
MFCD09954124
OR068058
OR272863
PB32822
Q-1947
Regnite
SCHEMBL25455
Solzira
TZDUHAJSIBHXDL-UHFFFAOYSA-N
XP 13512
XP-053
XP-13512
XP13512

US Patents and Regulatory Information for gabapentin enacarbil

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Glossary

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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	➤ Sign Up	➤ Sign Up				➤ Sign Up
Arbor Pharms Llc	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Arbor Pharms Llc	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Arbor Pharms Llc	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Non-Orange Book US Patents for gabapentin enacarbil

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.

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Patent No.	Title	Estimated Patent Expiration
9,238,616	Prodrugs of gaba analogs, compositions and uses thereof	➤ Sign Up
8,168,623	Prodrugs of GABA analogs, compositions and uses thereof	➤ Sign Up
7,186,855	Prodrugs of GABA analogs, compositions and uses thereof	➤ Sign Up
7,232,924	Methods for synthesis of acyloxyalkyl derivatives of GABA analogs	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

International Patents for gabapentin enacarbil

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Country	Document Number	Estimated Expiration
Japan	5107576	➤ Sign Up
European Patent Office	2085087	➤ Sign Up
China	1533270	➤ Sign Up
New Zealand	530109	➤ Sign Up
Country	Document Number	Estimated Expiration