Avandaryl is a drug owned by Sb Pharmco Puerto Rico Inc. It is protected by 4 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 Oct 19, 2020. Details of Avandaryl'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). | |||
|
US7358366 (Pediatric) | Thiazolidinedione derivative and its use as antidiabetic |
Oct, 2020
(4 years ago) |
Expired
|
| US7358366 | Thiazolidinedione derivative and its use as antidiabetic |
Apr, 2020
(4 years ago) |
Expired
|
|
US5741803 (Pediatric) | Substituted thiazolidinedionle derivatives |
Oct, 2015
(9 years ago) |
Expired
|
| US5741803 | Substituted thiazolidinedionle derivatives |
Apr, 2015
(9 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 Avandaryl's patents.
Latest Legal Activities on Avandaryl's Patents
Given below is the list of recent legal activities going on the following patents of Avandaryl.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 14 May, 2012 | US7358366 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Apr, 2008 | US7358366 |
| Recordation of Patent Grant Mailed Critical | 15 Apr, 2008 | US7358366 |
| Issue Notification Mailed Critical | 26 Mar, 2008 | US7358366 |
| Dispatch to FDC | 17 Mar, 2008 | US7358366 |
| Mail Response to 312 Amendment (PTO-271) Critical | 12 Mar, 2008 | US7358366 |
| Response to Amendment under Rule 312 Critical | 12 Mar, 2008 | US7358366 |
| Application Is Considered Ready for Issue Critical | 05 Mar, 2008 | US7358366 |
| Issue Fee Payment Verified Critical | 22 Feb, 2008 | US7358366 |
| Amendment after Notice of Allowance (Rule 312) Critical | 22 Feb, 2008 | US7358366 |
US patents provide insights into the exclusivity only within the United States, but Avandaryl 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 Avandaryl's family patents as well as insights into ongoing legal events on those patents.
Avandaryl's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Avandaryl's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 19, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Avandaryl Generic API suppliers:
Glimepiride; Rosiglitazone Maleate is the generic name for the brand Avandaryl. 1 company has already filed for the generic of Avandaryl. Check out the entire list of companies who have already received approval for Avandaryl's generic
How can I launch a generic of Avandaryl before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Avandaryl's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Avandaryl'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 Avandaryl -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/4 mg 2 mg/4 mg 4 mg/4 mg | 22 Dec, 2006 | 1 | 01 Apr, 2016 | 21 Oct, 2015 | Extinguished |
| 8 mg/2 mg 8 mg/4 mg | 30 May, 2008 | 1 | 01 Apr, 2016 | 19 Oct, 2020 | Eligible |
About Avandaryl
Avandaryl is a drug owned by Sb Pharmco Puerto Rico Inc. It is used for improving glycemic control in adult patients with type 2 diabetes mellitus who are naive to pharmacologic therapy. Avandaryl uses Glimepiride; Rosiglitazone Maleate as an active ingredient. Avandaryl was launched by Sb Pharmco in 2005.
Approval Date:
Avandaryl was approved by FDA for market use on 23 November, 2005.
Active Ingredient:
Avandaryl uses Glimepiride; Rosiglitazone Maleate as the active ingredient. Check out other Drugs and Companies using Glimepiride; Rosiglitazone Maleate ingredient
Treatment:
Avandaryl is used for improving glycemic control in adult patients with type 2 diabetes mellitus who are naive to pharmacologic therapy.
Dosage:
Avandaryl is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 2MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |