Plenaxis is a drug owned by Speciality European Pharma Ltd. It is protected by 6 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 Dec 11, 2016. Details of Plenaxis'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). | |||
| US6699833 | Pharmaceutical formulations for sustained drug delivery |
Dec, 2016
(9 years ago) |
Expired
|
| US5968895 | Pharmaceutical formulations for sustained drug delivery |
Dec, 2016
(9 years ago) |
Expired
|
| US6180608 | Pharmaceutical formulations for sustained drug delivery |
Dec, 2016
(9 years ago) |
Expired
|
| US5843901 | LHRH antagonist peptides |
Dec, 2015
(10 years ago) |
Expired
|
| US6423686 | LHRH antagonist peptides |
Jun, 2015
(11 years ago) |
Expired
|
| US6455499 | Methods for treating disorders associated with LHRH activity |
Jun, 2015
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Plenaxis 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 Plenaxis's family patents as well as insights into
ongoing legal events
on those patents.
Plenaxis's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Plenaxis:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. | Novartis Pharmaceuticals | NA | ACTIVE NOT RECRUITING
(Sep 1, 2026) | PHASE1 |
Generic Launch
Generic Release Date:
Plenaxis's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 11, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Plenaxis Generics:
There are no approved generic versions for Plenaxis as of now.
About Plenaxis
Plenaxis is a drug owned by Speciality European Pharma Ltd. It is used for treating advanced symptomatic prostate cancer in men. Plenaxis uses Abarelix as an active ingredient. Plenaxis was launched by Speciality European in 2003.
Approval Date:
Plenaxis was approved by FDA for market use on 25 November, 2003.
Active Ingredient:
Plenaxis uses Abarelix as the active ingredient. Check out other Drugs and Companies using Abarelix ingredient
Treatment:
Plenaxis is used for treating advanced symptomatic prostate cancer in men.
Dosage:
Plenaxis is available in powder form for intramuscular use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/VIAL | POWDER | Discontinued | INTRAMUSCULAR |