Ambien Cr is a drug owned by Sanofi Aventis Us Llc. It is protected by 2 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 Jun 01, 2020. Details of Ambien Cr'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). | |||
|
US6514531 (Pediatric) | Controlled-release dosage forms comprising zolpidem or a salt thereof |
Jun, 2020
(4 years ago) |
Expired
|
| US6514531 | Controlled-release dosage forms comprising zolpidem or a salt thereof |
Dec, 2019
(4 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 Ambien Cr's patents.
Latest Legal Activities on Ambien Cr's Patents
Given below is the list of recent legal activities going on the following patents of Ambien Cr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change Critical | 02 Aug, 2006 | US6514531 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 04 Feb, 2003 | US6514531 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 04 Feb, 2003 | US6514531 (Litigated) |
| Issue Notification Mailed Critical | 16 Jan, 2003 | US6514531 (Litigated) |
| Receipt into Pubs | 02 Jan, 2003 | US6514531 (Litigated) |
| Workflow - Drawings Matched with File at Contractor | 20 Dec, 2002 | US6514531 (Litigated) |
| Application Is Considered Ready for Issue Critical | 20 Dec, 2002 | US6514531 (Litigated) |
| Issue Fee Payment Received Critical | 09 Dec, 2002 | US6514531 (Litigated) |
| Issue Fee Payment Verified Critical | 09 Dec, 2002 | US6514531 (Litigated) |
| Receipt into Pubs | 15 Oct, 2002 | US6514531 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Ambien Cr 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 Ambien Cr's family patents as well as insights into ongoing legal events on those patents.
Ambien Cr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ambien Cr's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 01, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ambien Cr Generic API suppliers:
Zolpidem Tartrate is the generic name for the brand Ambien Cr. 30 different companies have already filed for the generic of Ambien Cr, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ambien Cr's generic
How can I launch a generic of Ambien Cr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ambien Cr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ambien Cr'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 Ambien Cr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 6.25 mg | 24 Feb, 2006 | 1 | 13 Oct, 2010 | 01 Jun, 2020 | Non-Forfeiture |
| 12.5 mg | 19 Jan, 2006 | 1 | 03 Dec, 2010 | 01 Jun, 2020 | Non-Forfeiture |
Alternative Brands for Ambien Cr
There are several other brand drugs using the same active ingredient (Zolpidem Tartrate) as Ambien Cr. 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 | |
|---|---|---|
| Aytu |
| |
| Mylan Speciality Lp |
| |
| Purdue Pharma |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Zolpidem Tartrate, Ambien Cr's active ingredient. Check the complete list of approved generic manufacturers for Ambien Cr
About Ambien Cr
Ambien Cr is a drug owned by Sanofi Aventis Us Llc. Ambien Cr uses Zolpidem Tartrate as an active ingredient. Ambien Cr was launched by Sanofi Aventis Us in 2005.
Approval Date:
Ambien Cr was approved by FDA for market use on 02 September, 2005.
Active Ingredient:
Ambien Cr uses Zolpidem Tartrate as the active ingredient. Check out other Drugs and Companies using Zolpidem Tartrate ingredient
Dosage:
Ambien Cr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 6.25MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |