Edluar is a drug owned by Mylan Specialty Lp. It is protected by 4 US drug patents filed from 2013 to 2017. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 25, 2031. Details of Edluar'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). | |||
| US9265720 | Pharmaceutical formulations useful in the treatment of insomnia |
Feb, 2031
(6 years from now) | Active |
| US9597281 | Pharmaceutical formulations useful in the treatment of insomnia |
Apr, 2027
(2 years from now) | Active |
| US6761910 | Pharmaceutical composition for the treatment of acute disorders |
Sep, 2019
(5 years ago) |
Expired
|
| US8512747 | Pharmaceutical composition for the treatment of acute disorders |
Sep, 2019
(5 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 Edluar's patents.
Latest Legal Activities on Edluar's Patents
Given below is the list of recent legal activities going on the following patents of Edluar.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 27 Sep, 2021 | US8512747 |
| Maintenance Fee Reminder Mailed Critical | 12 Apr, 2021 | US8512747 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Sep, 2020 | US9597281 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Mar, 2017 | US9597281 |
| Recordation of Patent Grant Mailed Critical | 21 Mar, 2017 | US9597281 |
| Issue Notification Mailed Critical | 01 Mar, 2017 | US9597281 |
| Application Is Considered Ready for Issue Critical | 08 Feb, 2017 | US9597281 |
| Dispatch to FDC | 08 Feb, 2017 | US9597281 |
| Issue Fee Payment Verified Critical | 03 Feb, 2017 | US9597281 |
| Issue Fee Payment Received Critical | 03 Feb, 2017 | US9597281 |
US patents provide insights into the exclusivity only within the United States, but Edluar 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 Edluar's family patents as well as insights into ongoing legal events on those patents.
Edluar's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Edluar's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 25, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Edluar Generic API suppliers:
Zolpidem Tartrate is the generic name for the brand Edluar. 30 different companies have already filed for the generic of Edluar, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Edluar's generic
How can I launch a generic of Edluar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Edluar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Edluar'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 Edluar -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | 29 Apr, 2010 | 1 | 01 Aug, 2016 | 24 Sep, 2018 | Extinguished |
Alternative Brands for Edluar
Edluar which is used for treating insomnia characterized by difficulty with sleep onset., has several other brand drugs in the same treatment category and using the same active ingredient (Zolpidem Tartrate). 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 | Treatment Area | ||
|---|---|---|---|---|
| Takeda Pharms Usa |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Zolpidem Tartrate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Aytu |
| |
| Purdue Pharma |
| |
| Sanofi Aventis Us |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Zolpidem Tartrate, Edluar's active ingredient. Check the complete list of approved generic manufacturers for Edluar
About Edluar
Edluar is a drug owned by Mylan Specialty Lp. It is used for treating insomnia characterized by difficulty with sleep onset. Edluar uses Zolpidem Tartrate as an active ingredient. Edluar was launched by Mylan Speciality Lp in 2009.
Approval Date:
Edluar was approved by FDA for market use on 13 March, 2009.
Active Ingredient:
Edluar uses Zolpidem Tartrate as the active ingredient. Check out other Drugs and Companies using Zolpidem Tartrate ingredient
Treatment:
Edluar is used for treating insomnia characterized by difficulty with sleep onset.
Dosage:
Edluar is available in tablet form for sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET | Prescription | SUBLINGUAL |
| 10MG | TABLET | Prescription | SUBLINGUAL |