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Last Updated: June 24, 2021

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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 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 2018 were $535mm indicating the motivation for generic entry.

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

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Drug Sales Revenue Trends for HORIZANT

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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
University of California, DavisPhase 3
National Institute on Aging (NIA)Phase 4
University of Texas at AustinPhase 4

See all HORIZANT clinical trials

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

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
McKinsey
AstraZeneca
Merck
Harvard Business School

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