Gabitril is a drug owned by Cephalon Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 10, 2017. Details of Gabitril's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5958951 | Modified form of the R(-)-N-(4,4-di(3-methylthien-2-yl)but-3-enyl)-nipecotic acid hydrochloride |
Jun, 2017
(7 years ago) |
Expired
|
| US5866590 | Pharmaceutical composition containing tiagabine hydrochloride and the process for its preparation |
Apr, 2016
(8 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Gabitril 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 Gabitril's family patents as well as insights into ongoing legal events on those patents.
Gabitril's Family Patents
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Generic Launch
Generic Release Date:
Gabitril's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 10, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gabitril Generic API suppliers:
Tiagabine Hydrochloride is the generic name for the brand Gabitril. 4 different companies have already filed for the generic of Gabitril, with Amneal Pharms Co having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Gabitril's generic
How can I launch a generic of Gabitril before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Gabitril's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Gabitril'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 Gabitril -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg and 4 mg | 01 Feb, 2005 | 1 | 04 Nov, 2011 | 10 Jun, 2017 | Eligible |
| 12 mg and 16 mg | 24 Jan, 2014 | 1 | 13 Oct, 2017 | 10 Jun, 2017 | Extinguished |
About Gabitril
Gabitril is a drug owned by Cephalon Inc. Gabitril uses Tiagabine Hydrochloride as an active ingredient. Gabitril was launched by Cephalon in 1999.
Approval Date:
Gabitril was approved by FDA for market use on 16 April, 1999.
Active Ingredient:
Gabitril uses Tiagabine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Tiagabine Hydrochloride ingredient
Dosage:
Gabitril is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12MG | TABLET | Prescription | ORAL |
| 16MG | TABLET | Prescription | ORAL |
| 2MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Discontinued | ORAL |
| 4MG | TABLET | Prescription | ORAL |