By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
DrugPatentWatch Database Preview
HORIZANT Drug Profile
Email this page to a colleague
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
Summary for HORIZANT
| International Patents: | 148 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 49 |
| Clinical Trials: | 10 |
| Patent Applications: | 301 |
| 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
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 |
|---|---|
| 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 |
ATC Classes for HORIZANT
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 |
International Patents for HORIZANT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2003297676 | Try Before You Buy |
| South Korea | 100958552 | Try Before You Buy |
| Mexico | 2007005306 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
