Horizant is a drug owned by Azurity Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2013 to 2014. Out of these, 3 drug patents are active and 3 have expired. Horizant's patents have been open to challenges since 07 April, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 10, 2029. Details of Horizant's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8026279 | Crystalline form of γ-aminobutyric acid analog |
Nov, 2026
(1 year, 5 months from now) | Active |
| US6818787 | Prodrugs of GABA analogs, compositions and uses thereof |
Apr, 2025
(a month ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8795725 | GABA analog prodrug sustained release oral dosage forms |
Jun, 2029
(4 years from now) | Active |
| US8114909 | Treating or preventing restless legs syndrome using prodrugs of GABA analogs |
Apr, 2026
(10 months from now) | Active |
| US8686034 | Crystalline form of γ-aminobutyric acid analog |
Jan, 2025
(3 months ago) |
Expired
|
| US8048917 | Prodrugs of GABA analogs, compositions and uses thereof |
Nov, 2022
(2 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Horizant's patents.
Latest Legal Activities on Horizant's Patents
Given below is the list of recent legal activities going on the following patents of Horizant.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Aug, 2023 | US8114909 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 May, 2023 | US8048917 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Mar, 2023 | US8026279 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Feb, 2022 | US8795725 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Oct, 2021 | US8686034 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Aug, 2019 | US8114909 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 May, 2019 | US8048917 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Mar, 2019 | US8026279 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Feb, 2018 | US8795725 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Oct, 2017 | US8686034 |
FDA has granted several exclusivities to Horizant. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Horizant, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Horizant.
Exclusivity Information
Horizant holds 4 exclusivities. All of its exclusivities have expired in 2019. Details of Horizant's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-652) | Jun 06, 2015 |
| New Chemical Entity Exclusivity(NCE) | Apr 06, 2016 |
| Orphan Drug Exclusivity(ODE) | Jun 06, 2019 |
| Orphan Drug Exclusivity(ODE-25) | Jun 06, 2019 |
Several oppositions have been filed on Horizant's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Horizant's generic, the next section provides detailed information on ongoing and past EP oppositions related to Horizant patents.
Horizant's Oppositions Filed in EPO
Horizant has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 04, 2008, by Breuer, Markus. This opposition was filed on patent number EP02744314A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP02744314A | Sep, 2008 | Breuer, Markus | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Horizant is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Horizant's family patents as well as insights into ongoing legal events on those patents.
Horizant's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Horizant's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 10, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Horizant Generics:
There are no approved generic versions for Horizant as of now.
How can I launch a generic of Horizant before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Horizant's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Horizant's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Horizant -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 300 mg and 600 mg | 29 Apr, 2019 | 1 | 10 Jun, 2029 |
About Horizant
Horizant is a drug owned by Azurity Pharmaceuticals Inc. It is used for managing postherpetic neuralgia in adults and treating moderate-to-severe primary restless leg syndrome in adults. Horizant uses Gabapentin Enacarbil as an active ingredient. Horizant was launched by Azurity in 2011.
Approval Date:
Horizant was approved by FDA for market use on 13 December, 2011.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Horizant is 13 December, 2011, its NCE-1 date is estimated to be 07 April, 2015.
Active Ingredient:
Horizant uses Gabapentin Enacarbil as the active ingredient. Check out other Drugs and Companies using Gabapentin Enacarbil ingredient
Treatment:
Horizant is used for managing postherpetic neuralgia in adults and treating moderate-to-severe primary restless leg syndrome in adults.
Dosage:
Horizant is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 600MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 300MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |