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HORIZANT Drug Profile

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Which patents cover Horizant, and when can generic versions of Horizant launch?

Horizant is a drug marketed by Arbor Pharms Llc and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and forty-seven patent family members in twenty-five countries.

The generic ingredient in HORIZANT is gabapentin enacarbil. There are twenty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the gabapentin enacarbil profile page.

Summary for HORIZANT

International Patents:	147
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	34
Clinical Trials:	9
Patent Applications:	75
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for HORIZANT
DailyMed Link:	HORIZANT at DailyMed

Generic Entry Opportunity Date for HORIZANT

NDA:

022399

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for HORIZANT

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

Synonyms for HORIZANT

(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

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 (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 HORIZANT

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	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	022399-002	Dec 13, 2011		RX	Yes	No			Y	Y

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Non-Orange Book US Patents for HORIZANT

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.

Patent No.	Title	Estimated Patent Expiration
7,790,708	Prodrugs of GABA analogs, compositions and uses thereof
6,833,140	Orally administered dosage forms of GABA analog prodrugs having reduced toxicity
8,906,412	GABA analog prodrug sustained release oral dosage forms

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International Patents for HORIZANT

Country	Document Number	Estimated Expiration
Japan	2007508396
Japan	5107576
Brazil	PI0414481