HORIZANT Drug Patent Profile

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

Horizant is a drug marketed by Azurity and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-six 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.

DrugPatentWatch^® 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 2019 were $308mm indicating the motivation for generic entry (peak sales were $535mm in 2018).

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for HORIZANT

International Patents:	146
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	14
Patent Applications:	253
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for HORIZANT
Drug Sales Revenues:	Drug sales revenues for HORIZANT
What excipients (inactive ingredients) are in HORIZANT?	HORIZANT excipients list
DailyMed Link:	HORIZANT at DailyMed

See drug prices for HORIZANT

See drug sales revenues for HORIZANT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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
Massachusetts General Hospital	Phase 4
University of California, Davis	Phase 3
National Institute on Aging (NIA)	Phase 4

See all HORIZANT clinical trials

Pharmacology for HORIZANT

Physiological Effect

Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for HORIZANT

N02BF	Gabapentinoids
N02B	OTHER ANALGESICS AND ANTIPYRETICS
N02	ANALGESICS
N	Nervous system

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for HORIZANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HORIZANT	Extended-release Tablets	gabapentin enacarbil	300 mg and 600 mg	022399	1	2019-04-29

US Patents and Regulatory Information for HORIZANT

HORIZANT is protected by seven US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting HORIZANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No			Y	Y
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No			Y

Expired US Patents for HORIZANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011

International Patents for HORIZANT

When does loss-of-exclusivity occur for HORIZANT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Japan

Mexico

New Zealand

Norway

Russian Federation

South Africa

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering HORIZANT around the world.

Country	Patent Number	Title	Estimated Expiration
China	1867322	Crystalline form of gamma-aminobutyric acid analog
Australia	2004274002	Treating or preventing restless legs syndrome using prodrugs of GABA analogs
Hong Kong	1087628	PRODRUGS OF GABA ANALOGS, COMPOSITIONS AND USES THEREOF GABA