Suprenza is a drug owned by Citius Pharmaceuticals Llc. It is protected by 2 US drug patents filed in 2013. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 14, 2029. Details of Suprenza'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). | |||
| US8440170 | Orally disintegrating tablets with speckled appearance |
Mar, 2029
(4 years from now) | Active |
| US6149938 | Process for the preparation of a granulate suitable to the preparation of rapidly disintegrable mouth-soluble tablets and compositions obtained thereby |
Jul, 2018
(6 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 Suprenza's patents.
Latest Legal Activities on Suprenza's Patents
Given below is the list of recent legal activities going on the following patents of Suprenza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 09 Nov, 2020 | US8440170 |
| Review Certificate Mailed | 16 Feb, 2018 | US8440170 |
| Review Certificate | 22 Dec, 2017 | US8440170 |
| Termination or Final Written Decision | 11 Oct, 2016 | US8440170 |
| Request for Trial Granted Critical | 20 May, 2016 | US8440170 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 07 Dec, 2015 | US8440170 |
| Petition Requesting Trial | 24 Nov, 2015 | US8440170 |
| Patent Issue Date Used in PTA Calculation Critical | 14 May, 2013 | US8440170 |
| Recordation of Patent Grant Mailed Critical | 14 May, 2013 | US8440170 |
| Email Notification Critical | 25 Apr, 2013 | US8440170 |
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 Suprenza and ongoing litigations to help you estimate the early arrival of Suprenza generic.
Suprenza's Litigations
Suprenza been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 24, 2015, against patent number US8440170. The petitioner Spangenberg, Erich et al., challenged the validity of this patent, with ALPEX PHARMA as the respondent. Click below to track the latest information on how companies are challenging Suprenza's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8440170 | November, 2015 |
Terminated
(11 Oct, 2016) | ALPEX PHARMA | Spangenberg, Erich et al. |
US patents provide insights into the exclusivity only within the United States, but Suprenza 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 Suprenza's family patents as well as insights into ongoing legal events on those patents.
Suprenza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Suprenza's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 14, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Suprenza Generic API suppliers:
Phentermine Hydrochloride is the generic name for the brand Suprenza. 37 different companies have already filed for the generic of Suprenza, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Suprenza's generic
How can I launch a generic of Suprenza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Suprenza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Suprenza'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 Suprenza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg and 30 mg | 19 Oct, 2012 | 1 | 28 Jun, 2017 | 23 Jul, 2018 | Deferred |
| 37.5 mg | 22 Mar, 2013 | 1 | 28 Jun, 2017 | 23 Jul, 2018 | Deferred |
Alternative Brands for Suprenza
Suprenza which is used for weight management in adults as part of a comprehensive program that includes lifestyle changes., has several other brand drugs using the same active ingredient (Phentermine Hydrochloride). 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 | |
|---|---|---|
| Vivus Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Phentermine Hydrochloride, Suprenza's active ingredient. Check the complete list of approved generic manufacturers for Suprenza
About Suprenza
Suprenza is a drug owned by Citius Pharmaceuticals Llc. It is used for weight management in adults as part of a comprehensive program that includes lifestyle changes. Suprenza uses Phentermine Hydrochloride as an active ingredient. Suprenza was launched by Citius Pharms in 2011.
Approval Date:
Suprenza was approved by FDA for market use on 13 June, 2011.
Active Ingredient:
Suprenza uses Phentermine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Phentermine Hydrochloride ingredient
Treatment:
Suprenza is used for weight management in adults as part of a comprehensive program that includes lifestyle changes.
Dosage:
Suprenza is available in tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |