Avandia is a drug owned by Woodward Pharma Services 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 Oct 19, 2020. Details of Avandia'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
|
|
US6288095 (Pediatric) | Compounds |
Aug, 2017
(7 years ago) |
Expired
|
| US6288095 | Compounds |
Feb, 2017
(7 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 Avandia's patents.
Latest Legal Activities on Avandia's Patents
Given below is the list of recent legal activities going on the following patents of Avandia.
| 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 Avandia 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 Avandia's family patents as well as insights into ongoing legal events on those patents.
Avandia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Avandia'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)
Avandia Generic API suppliers:
Rosiglitazone Maleate is the generic name for the brand Avandia. 1 company has already filed for the generic of Avandia. Check out the entire list of companies who have already received approval for Avandia's generic
How can I launch a generic of Avandia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Avandia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Avandia'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 Avandia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg, 4 mg and 8 mg |
Alternative Brands for Avandia
Avandia which is used for managing and improving glycemic control in patients with type 2 diabetes mellitus., has several other brand drugs using the same active ingredient (Rosiglitazone Maleate). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Rosiglitazone Maleate, Avandia's active ingredient. Check the complete list of approved generic manufacturers for Avandia
About Avandia
Avandia is a drug owned by Woodward Pharma Services Llc. It is used for managing and improving glycemic control in patients with type 2 diabetes mellitus. Avandia uses Rosiglitazone Maleate as an active ingredient. Avandia was launched by Woodward in 1999.
Approval Date:
Avandia was approved by FDA for market use on 25 May, 1999.
Active Ingredient:
Avandia uses Rosiglitazone Maleate as the active ingredient. Check out other Drugs and Companies using Rosiglitazone Maleate ingredient
Treatment:
Avandia is used for managing and improving glycemic control in patients with type 2 diabetes mellitus.
Dosage:
Avandia is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 4MG BASE | TABLET | Discontinued | ORAL |
| EQ 2MG BASE | TABLET | Discontinued | ORAL |