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HORIZANT Drug Patent Profile

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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 2021 were $171mm 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

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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

Drug patent expirations by year for HORIZANT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for HORIZANT

Generic Entry Date for HORIZANT^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of HORIZANT is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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

Prodrugs of GABA analogs, compositions and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Crystalline form of .gamma.-aminobutyric acid analog
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Treating or preventing restless legs syndrome using prodrugs of GABA analogs
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS

Crystalline form of .gamma.-aminobutyric acid analog
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS

Crystalline form of .gamma.-aminobutyric acid analog
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS

GABA analog prodrug sustained release oral dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS

GABA analog prodrug sustained release oral dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS

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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
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-002	Dec 13, 2011		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for HORIZANT

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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	⤷ Try a Trial	⤷ Try a Trial
Azurity	HORIZANT	gabapentin enacarbil	TABLET, EXTENDED RELEASE;ORAL	022399-001	Apr 6, 2011	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

Patent: 05301970
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 0517227
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 84338
Estimated Expiration: ⤷ Try a Trial

China

Patent: 1068538
Estimated Expiration: ⤷ Try a Trial

Patent: 2429882
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 11986
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 04798
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 56095
Estimated Expiration: ⤷ Try a Trial

Patent: 08518971
Estimated Expiration: ⤷ Try a Trial

Patent: 13107900
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 07005306
Estimated Expiration: ⤷ Try a Trial

New Zealand

Patent: 4737
Estimated Expiration: ⤷ Try a Trial

Norway

Patent: 8688
Estimated Expiration: ⤷ Try a Trial

Patent: 072767
Estimated Expiration: ⤷ Try a Trial

Russian Federation

Patent: 40112
Estimated Expiration: ⤷ Try a Trial

Patent: 07120570
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 0703571
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 1228399
Estimated Expiration: ⤷ Try a Trial

Patent: 070074604
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 77938
Estimated Expiration: ⤷ Try a Trial

Patent: 0630086
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
Norway	20061655		⤷ Try a Trial
European Patent Office	2085087	Promédicaments d'analogues gaba, compositions et leurs utilisations (Prodrugs of gaba analogs, compositions and uses thereof)	⤷ Try a Trial
China	1533270	具有降低毒性的GABA类似物前药的口服给药剂型 (Oral administered dosage form of GABA anolog prodrugs having reduced toxicity)	⤷ Try a Trial
New Zealand	530109	Prodrugs of GABA analogs, compositions and uses thereof	⤷ Try a Trial
Canada	2449673	FORMES DE DOSAGE DE PROMEDICAMENTS A FAIBLE TOXICITE A BASE D'ANALOGUES DU GABA, ADMINISTREES PAR VOIE ORALE (ORALLY ADMINISTERED DOSAGE FORMS OF GABA ANALOG PRODRUGS HAVING REDUCED TOXICITY)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration