Eszopiclone Patent Expiration

Eszopiclone is used for inducing hypnotic or sedative effects in humans. It was first introduced by Waylis Therapeutics Llc in its drug Lunesta on Dec 15, 2004. 15 different companies have introduced drugs containing Eszopiclone.


Eszopiclone Patents

Given below is the list of patents protecting Eszopiclone, 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
Lunesta US6444673

(Pediatric)

Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing it Aug 14, 2014

(Expired)

Waylis Therap
Lunesta US6444673 Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing it Feb 14, 2014

(Expired)

Waylis Therap
Lunesta US6864257

(Pediatric)

Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing it Mar 02, 2013

(Expired)

Waylis Therap
Lunesta US6864257 Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing it Aug 30, 2012

(Expired)

Waylis Therap
Lunesta US6319926

(Pediatric)

Optically active 5H-pyrrolo[3, 4-B]pyrazine derivative, its preparation and pharmaceutical compositions containing it Jul 16, 2012

(Expired)

Waylis Therap
Lunesta US7381724

(Pediatric)

Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing same Jul 16, 2012

(Expired)

Waylis Therap



Eszopiclone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Eszopiclone:

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
Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping Flinders University NA RECRUITING
(Sep 1, 2026)
PHASE2
National Adaptive Trial for PTSD Related Insomnia VA Office of Research and Development NA COMPLETED
(Jun 1, 2026)
PHASE3
Do Endotypes Predict Response and Sequelae in OSA Patients University of California, San Diego NA COMPLETED
(Jun 1, 2026)
PHASE2
Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea Yale University NA RECRUITING
(Jun 1, 2026)
PHASE3


Eszopiclone Generic API Manufacturers

Several generic applications have been filed for Eszopiclone. The first generic version for Eszopiclone was by Teva Pharmaceuticals Usa Inc and was approved on May 23, 2011. And the latest generic version is by Hetero Labs Ltd Unit V and was approved on Jan 4, 2024.

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