Forfivo Xl is a drug owned by Twi Pharmaceuticals Inc. It is protected by 1 US drug patent filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 25, 2027. Details of Forfivo Xl'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). | |||
| US7674479 | Sustained-release bupropion and bupropion/mecamylamine tablets |
Jun, 2027
(2 years from now) | Active |
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 Forfivo Xl's patents.
Latest Legal Activities on Forfivo Xl's Patents
Given below is the list of recent legal activities going on the following patents of Forfivo Xl.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Sep, 2021 | US7674479 |
| Mail O.P. Petition Decision | 22 Feb, 2018 | US7674479 |
| Email Notification Critical | 22 Feb, 2018 | US7674479 |
| Mail-Petition Decision - Granted | 21 Feb, 2018 | US7674479 |
| Payment of Maintenance Fee under 1.28(c) | 20 Feb, 2018 | US7674479 |
| O.P. Petition Decision | 20 Feb, 2018 | US7674479 |
| Petition Decision - Granted Critical | 20 Feb, 2018 | US7674479 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 29 Aug, 2017 | US7674479 |
| Petition Entered | 29 Aug, 2017 | US7674479 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 28 Aug, 2017 | US7674479 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Forfivo Xl and ongoing litigations to help you estimate the early arrival of Forfivo Xl generic.
Forfivo Xl's Litigations
Forfivo Xl been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 23, 2008, against patent number US7674479. The petitioner , challenged the validity of this patent, with Horst G. Zerbe et al as the respondent. Click below to track the latest information on how companies are challenging Forfivo Xl's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7674479 | December, 2008 |
Decision
(23 Sep, 2009) | Horst G. Zerbe et al | |
US patents provide insights into the exclusivity only within the United States, but Forfivo Xl 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 Forfivo Xl's family patents as well as insights into ongoing legal events on those patents.
Forfivo Xl's Family Patents
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Generic Launch
Generic Release Date:
Forfivo Xl's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 25, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Forfivo Xl Generic API suppliers:
Bupropion Hydrochloride is the generic name for the brand Forfivo Xl. 35 different companies have already filed for the generic of Forfivo Xl, with Aurobindo Pharma Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Forfivo Xl's generic
How can I launch a generic of Forfivo Xl before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Forfivo Xl's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Forfivo Xl'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 Forfivo Xl -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 450 mg | 28 Feb, 2013 | 1 | 25 Jun, 2027 | Extinguished |
Alternative Brands for Forfivo Xl
There are several other brand drugs using the same active ingredient (Bupropion Hydrochloride) as Forfivo Xl. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Axsome |
| ||
| Bausch |
| ||
| Glaxosmithkline |
| ||
| Nalpropion |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Bupropion Hydrochloride, Forfivo Xl's active ingredient. Check the complete list of approved generic manufacturers for Forfivo Xl
About Forfivo Xl
Forfivo Xl is a drug owned by Twi Pharmaceuticals Inc. Forfivo Xl uses Bupropion Hydrochloride as an active ingredient. Forfivo Xl was launched by Twi Pharms in 2011.
Approval Date:
Forfivo Xl was approved by FDA for market use on 10 November, 2011.
Active Ingredient:
Forfivo Xl uses Bupropion Hydrochloride as the active ingredient. Check out other Drugs and Companies using Bupropion Hydrochloride ingredient
Dosage:
Forfivo Xl is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 450MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |