Nexiclon Xr is a drug owned by Rosemount Pharmaceuticals Llc. It is protected by 2 US drug patents filed in 2020 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 08, 2031. Details of Nexiclon Xr'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). | |||
| US8623409 | Clonidine formulation |
Sep, 2031
(4 years from now) | Active |
| US8337890 | Modified release formulations containing drug-ion exchange resin complexes |
Apr, 2027
(6 months 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 Nexiclon Xr's patents.
Latest Legal Activities on Nexiclon Xr's Patents
Given below is the list of recent legal activities going on the following patents of Nexiclon Xr.
| Activity | Date | Patent Number |
|---|---|---|
| ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Jun, 2025 | US8623409 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 May, 2024 | US8337890 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Jun, 2021 | US8623409 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jun, 2020 | US8337890 |
| Correspondence Address Change
Critical | 04 Apr, 2014 | US8337890 |
| Patent Issue Date Used in PTA Calculation
Critical | 07 Jan, 2014 | US8623409 |
| Recordation of Patent Grant Mailed
Critical | 07 Jan, 2014 | US8623409 |
| Email Notification
Critical | 19 Dec, 2013 | US8623409 |
| Issue Notification Mailed
Critical | 18 Dec, 2013 | US8623409 |
| Dispatch to FDC | 13 Dec, 2013 | US8623409 |
US patents provide insights into the exclusivity only within the United States, but
Nexiclon Xr 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 Nexiclon Xr's family patents as well as insights into
ongoing legal events
on those patents.
Nexiclon Xr's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Nexiclon Xr:
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 |
|---|---|---|---|---|
| ||||
| Effect of Sublingual Formulation of Dexmedetomidine Hydrochloride (HCl) (BXCL501) - Outpatient Study | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | NA | RECRUITING
(Sep 1, 2026) | PHASE1 |
| The PREVENT AGITATION Trial II - Children ≤1 Year | Rigshospitalet, Denmark | NA | RECRUITING
(Aug 1, 2026) | PHASE2, PHASE3 |
| An Investigation of FID 123472 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness in Adults | Alcon Research | NA | NOT YET RECRUITING
(Aug 1, 2026) | PHASE3 |
| Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists | Leiden University Medical Center | NA | TERMINATED
(Jul 1, 2026) | PHASE1 |
| Ketamine-Assisted Psychotherapy for Treatment-Resistant Depression | University of Rochester | NA | NOT YET RECRUITING
(Apr 1, 2026) | PHASE2 |
| Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study | University of Wisconsin, Madison | NA | NOT YET RECRUITING
(Apr 1, 2026) | PHASE1 |
| Repurposing Low-Dose Clonidine for PTSD in Veterans | Wake Forest University Health Sciences | NA | RECRUITING
(Mar 1, 2026) | PHASE3 |
| ACT_for Alcohol Use Disorder and Depression | Centre hospitalier de l'Université de Montréal (CHUM) | NA | RECRUITING
(Mar 1, 2026) | |
Generic Launch
Generic Release Date:
Nexiclon Xr's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 08, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nexiclon Xr Generic API suppliers:
Clonidine is the generic name for the brand Nexiclon Xr. 4 different companies have already filed for the generic of Nexiclon Xr, with Actavis Labs Ut Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nexiclon Xr's generic
Alternative Brands for Nexiclon Xr
Nexiclon Xr which is used for treating high blood pressure, chest pain, and heart failure., has several other brand drugs using the same active ingredient (Clonidine). 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 | ||
|---|---|---|---|
| Azurity |
| ||
| Cmp Dev Llc |
| ||
| Concordia Pharms Inc |
| ||
| Tris Pharma Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Clonidine, Nexiclon Xr's active ingredient. Check the complete list of approved generic manufacturers for Nexiclon Xr
About Nexiclon Xr
Nexiclon Xr is a drug owned by Rosemount Pharmaceuticals Llc. It is used for treating high blood pressure, chest pain, and heart failure. Nexiclon Xr uses Clonidine as an active ingredient. Nexiclon Xr was launched by Rosemount in 2009.
Approval Date:
Nexiclon Xr was approved by FDA for market use on 03 December, 2009.
Active Ingredient:
Nexiclon Xr uses Clonidine as the active ingredient. Check out other Drugs and Companies using Clonidine ingredient
Treatment:
Nexiclon Xr is used for treating high blood pressure, chest pain, and heart failure.
Dosage:
Nexiclon Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.26MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 0.17MG BASE | TABLET, EXTENDED RELEASE | Prescription | ORAL |
