Augmentin Xr is a drug owned by Us Antibiotics Llc. It is protected by 5 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 04, 2020. Details of Augmentin Xr'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). | |||
| US7250176 | Method of treating a bacterial infection |
Apr, 2020
(4 years ago) |
Expired
|
| US6783773 | Composition comprising amoxicillin and potassium clavulanate |
Apr, 2020
(4 years ago) |
Expired
|
| US7217430 | Compositions and methods of treatment comprising amoxicillin and potassium clavulanate with xanthan |
Apr, 2020
(4 years ago) |
Expired
|
| US6878386 | Method of treating a bacterial infection comprising amoxycillin and potassium clavulanate |
Apr, 2020
(4 years ago) |
Expired
|
| US6746692 | Modified release pharmaceutical formulation comprising amoxycillin |
Apr, 2020
(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 Augmentin Xr's patents.
Latest Legal Activities on Augmentin Xr's Patents
Given below is the list of recent legal activities going on the following patents of Augmentin Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Oct, 2018 | US7217430 |
| Patent Issue Date Used in PTA Calculation Critical | 15 May, 2007 | US7217430 |
| Recordation of Patent Grant Mailed Critical | 15 May, 2007 | US7217430 |
| Issue Notification Mailed Critical | 25 Apr, 2007 | US7217430 |
| Dispatch to FDC | 13 Apr, 2007 | US7217430 |
| Printer Rush- No mailing | 01 Mar, 2007 | US7217430 |
| Pubs Case Remand to TC Critical | 19 Jan, 2007 | US7217430 |
| Application Is Considered Ready for Issue Critical | 20 Dec, 2006 | US7217430 |
| Issue Fee Payment Verified Critical | 12 Dec, 2006 | US7217430 |
| Issue Fee Payment Received Critical | 12 Dec, 2006 | US7217430 |
US patents provide insights into the exclusivity only within the United States, but Augmentin Xr 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 Augmentin Xr's family patents as well as insights into ongoing legal events on those patents.
Augmentin Xr's Family Patents
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Generic Launch
Generic Release Date:
Augmentin Xr's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 04, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Augmentin Xr Generic API suppliers:
Amoxicillin; Clavulanate Potassium is the generic name for the brand Augmentin Xr. 14 different companies have already filed for the generic of Augmentin Xr, with Sun Pharm Inds Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Augmentin Xr's generic
How can I launch a generic of Augmentin Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Augmentin Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Augmentin Xr'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 Augmentin Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1000 mg/62.5 mg | 21 Jan, 2009 | 1 | 21 Apr, 2010 | 04 Apr, 2020 | Eligible |
About Augmentin Xr
Augmentin Xr is a drug owned by Us Antibiotics Llc. It is used for treating community-acquired pneumonia and bacterial sinusitis caused by resistant bacterial pathogens such as beta-lactamase-producing pathogens and penicillin-resistant Streptococcus pneumoniae. Augmentin Xr uses Amoxicillin; Clavulanate Potassium as an active ingredient. Augmentin Xr was launched by Us Antibiotics in 2002.
Approval Date:
Augmentin Xr was approved by FDA for market use on 25 September, 2002.
Active Ingredient:
Augmentin Xr uses Amoxicillin; Clavulanate Potassium as the active ingredient. Check out other Drugs and Companies using Amoxicillin; Clavulanate Potassium ingredient
Treatment:
Augmentin Xr is used for treating community-acquired pneumonia and bacterial sinusitis caused by resistant bacterial pathogens such as beta-lactamase-producing pathogens and penicillin-resistant Streptococcus pneumoniae.
Dosage:
Augmentin Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |