Lunesta is a drug owned by Waylis Therapeutics Llc. 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 Apr 10, 2016. Details of Lunesta'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). | |||
|
US6444673 (Pediatric) | Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing it |
Aug, 2014
(10 years ago) |
Expired
|
| US6444673 | Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing it |
Feb, 2014
(10 years ago) |
Expired
|
|
US6864257 (Pediatric) | Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing it |
Mar, 2013
(11 years ago) |
Expired
|
| US6864257 | Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing it |
Aug, 2012
(12 years ago) |
Expired
|
|
US7381724 (Pediatric) | Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing same |
Jul, 2012
(12 years ago) |
Expired
|
|
US6319926 (Pediatric) | Optically active 5H-pyrrolo[3, 4-B]pyrazine derivative, its preparation and pharmaceutical compositions containing it |
Jul, 2012
(12 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 Lunesta's patents.
Latest Legal Activities on Lunesta's Patents
Given below is the list of recent legal activities going on the following patents of Lunesta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 01 Jul, 2016 | US7381724 |
| Expire Patent Critical | 08 Apr, 2013 | US6864257 |
| Patent Issue Date Used in PTA Calculation Critical | 03 Jun, 2008 | US7381724 |
| Recordation of Patent Grant Mailed Critical | 03 Jun, 2008 | US7381724 |
| Issue Notification Mailed Critical | 14 May, 2008 | US7381724 |
| Dispatch to FDC | 08 May, 2008 | US7381724 |
| Application Is Considered Ready for Issue Critical | 25 Apr, 2008 | US7381724 |
| Issue Fee Payment Received Critical | 24 Apr, 2008 | US7381724 |
| Issue Fee Payment Verified Critical | 24 Apr, 2008 | US7381724 |
| Mail Notice of Allowance Critical | 17 Apr, 2008 | US7381724 |
FDA has granted several exclusivities to Lunesta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lunesta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Lunesta.
Exclusivity Information
Lunesta holds 2 exclusivities. All of its exclusivities have expired in 2016. Details of Lunesta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-61) | Oct 10, 2015 |
| Pediatric Exclusivity(PED) | Apr 10, 2016 |
US patents provide insights into the exclusivity only within the United States, but Lunesta 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 Lunesta's family patents as well as insights into ongoing legal events on those patents.
Lunesta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lunesta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 10, 2016 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lunesta Generic API suppliers:
Eszopiclone is the generic name for the brand Lunesta. 14 different companies have already filed for the generic of Lunesta, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lunesta's generic
How can I launch a generic of Lunesta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lunesta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lunesta'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 Lunesta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg, 2 mg and 3 mg | 15 Dec, 2008 | 10 | 23 May, 2011 | 30 Aug, 2012 | Eligible |
About Lunesta
Lunesta is a drug owned by Waylis Therapeutics Llc. It is used for inducing hypnotic or sedative effects in humans. Lunesta uses Eszopiclone as an active ingredient. Lunesta was launched by Waylis Therap in 2004.
Approval Date:
Lunesta was approved by FDA for market use on 15 December, 2004.
Active Ingredient:
Lunesta uses Eszopiclone as the active ingredient. Check out other Drugs and Companies using Eszopiclone ingredient
Treatment:
Lunesta is used for inducing hypnotic or sedative effects in humans.
Dosage:
Lunesta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG | TABLET | Prescription | ORAL |
| 2MG | TABLET | Prescription | ORAL |
| 3MG | TABLET | Prescription | ORAL |