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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-eight patent family members in twenty-six countries.

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

US ANDA Litigation and Generic Entry Outlook for Horizant

Horizant was eligible for patent challenges on April 6, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 10, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $221mm indicating the motivation for generic entry (peak sales were $240mm in 2016).

Indicators of Generic Entry

Summary for HORIZANT

International Patents:	148
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	43
Clinical Trials:	10
Patent Applications:	78
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for HORIZANT
Drug Sales Revenues:	Drug sales revenues for HORIZANT
DailyMed Link:	HORIZANT at DailyMed

See drug prices for HORIZANT

See drug sales revenues for HORIZANT

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.

Recent Clinical Trials for HORIZANT

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

Sponsor	Phase
University of California, Davis	Phase 3
University of Texas at Austin	Phase 4
National Institute on Aging (NIA)	Phase 4

See all HORIZANT clinical trials

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

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

Gabapentin enacarbil (JAN/USAN/INN)

Gabapentin enacarbil [USAN:INN]

gabapentina enacarbilo

gabapentine enacarbil

gabapentinum enacarbilum

GSK 1838262

GSK-1838262

GSK1838262

GTPL7560

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 HORIZANT

Tradename	Dosage	Ingredient	NDA	Submissiondate
HORIZANT	TABLET, EXTENDED RELEASE;ORAL	gabapentin enacarbil	022399	2019-04-29

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
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
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	022399-001	Apr 6, 2011		RX	Yes	Yes			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			Y	Y

International Patents for HORIZANT

Country	Patent Number	Estimated Expiration
Slovenia	1677767
Norway	20061655
Brazil	PI0517227
Norway	20035473
Russian Federation	2006116470
Taiwan	I377938
South Korea	101096480