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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.
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
Summary for HORIZANT
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||49|
|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 Generic Entry Opportunity Date for HORIZANT
*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
|University of California, Davis||Phase 3|
|National Institute on Aging (NIA)||Phase 4|
|University of Texas at Austin||Phase 4|
Pharmacology for HORIZANT
|Drug Class||Anti-epileptic Agent |
|Physiological Effect||Decreased Central Nervous System Disorganized Electrical Activity |
|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|