Clonidine Patent Expiration

Clonidine is used for treating high blood pressure, chest pain, and heart failure. It was first introduced by Lavipharm Sa in its drug Catapres-Tts-1 on Oct 10, 1984. Other drugs containing Clonidine are Catapres-Tts-2, Clonidine, Nexiclon Xr, Catapres-Tts-3. 7 different companies have introduced drugs containing Clonidine.


Clonidine Patents

Given below is the list of patents protecting Clonidine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Nexiclon Xr US8623409 Clonidine formulation Sep 08, 2031 Rosemount
Nexiclon Xr US8337890 Modified release formulations containing drug-ion exchange resin complexes Apr 17, 2027 Rosemount



Clonidine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Clonidine:

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
Clinical Trials
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)


Clonidine Generic API Manufacturers

Several generic applications have been filed for Clonidine. The first generic version for Clonidine was by Difgen Pharmaceuticals Llc and was approved on Aug 18, 2009. And the latest generic version is by Actavis Laboratories Ut Inc and was approved on May 6, 2014.

Given below is the list of companies who have filed for Clonidine generic, along with the locations of their manufacturing plants worldwide.