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 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 |



DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Sponsor | Phase |
---|---|
Massachusetts General Hospital | Phase 4 |
University of California, Davis | Phase 3 |
National Institute on Aging (NIA) | Phase 4 |
Pharmacology for HORIZANT
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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 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
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 | |||
>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
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1867322 | Crystalline form of gamma-aminobutyric acid analog | ⤷ Try a Trial |
Australia | 2004274002 | Treating or preventing restless legs syndrome using prodrugs of GABA analogs | ⤷ Try a Trial |
Hong Kong | 1087628 | PRODRUGS OF GABA ANALOGS, COMPOSITIONS AND USES THEREOF GABA | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |