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Last Updated: August 19, 2022

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 six patents protecting this drug and one Paragraph IV challenge.

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.

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

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Drug patent expirations by year for HORIZANT
Drug Prices for HORIZANT

See drug prices for HORIZANT

Drug Sales Revenue Trends for HORIZANT

See drug sales revenues for HORIZANT

DrugPatentWatch® Estimated Generic Entry Opportunity Date for HORIZANT
Generic Entry Date for HORIZANT*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Massachusetts General HospitalPhase 4
University of California, DavisPhase 3
University of Texas at AustinPhase 4

See all HORIZANT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for HORIZANT
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 eight US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of HORIZANT is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline form of .gamma.-aminobutyric acid analog
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of GABA analogs, compositions and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS

Treating or preventing restless legs syndrome using prodrugs of GABA analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS

Crystalline form of .gamma.-aminobutyric acid analog
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS

Crystalline form of .gamma.-aminobutyric acid analog
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS

GABA analog prodrug sustained release oral dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS

GABA analog prodrug sustained release oral dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS

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

Brazil

Patent: 0517227
Estimated Expiration: See Plans and Pricing

Canada

Patent: 84338
Estimated Expiration: See Plans and Pricing

China

Patent: 1068538
Estimated Expiration: See Plans and Pricing

Patent: 2429882
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 11986
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 04798
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2964
Estimated Expiration: See Plans and Pricing

Japan

Patent: 56095
Estimated Expiration: See Plans and Pricing

Patent: 08518971
Estimated Expiration: See Plans and Pricing

Patent: 13107900
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07005306
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4737
Estimated Expiration: See Plans and Pricing

Norway

Patent: 8688
Estimated Expiration: See Plans and Pricing

Patent: 072767
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 40112
Estimated Expiration: See Plans and Pricing

Patent: 07120570
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0703571
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1228399
Estimated Expiration: See Plans and Pricing

Patent: 070074604
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 77938
Estimated Expiration: See Plans and Pricing

Patent: 0630086
Estimated Expiration: See Plans and Pricing

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
Singapore 147437 CRYSTALLINE FORM OF GAMMA-AMINOBUTYRIC ACID ANALOG See Plans and Pricing
South Korea 20070074604 See Plans and Pricing
Australia 2005301970 See Plans and Pricing
South Korea 20060106815 TREATING OR PREVENTING RESTLESS LEGS SYNDROME USING PRODRUGS OF GABA ANALOGS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.