Avandamet is a drug owned by Sb Pharmco Puerto Rico Inc. It is protected by 9 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 07, 2022. Details of Avandamet'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). | |||
| US8236345 | Composition and use |
Oct, 2022
(2 years ago) |
Expired
|
|
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
|
| US6166042 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US5965584 | Pharmaceutical composition |
Jun, 2016
(8 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 Avandamet's patents.
Latest Legal Activities on Avandamet's Patents
Given below is the list of recent legal activities going on the following patents of Avandamet.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 25 Mar, 2024 | US8236345 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jan, 2020 | US8236345 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Aug, 2012 | US8236345 |
| Recordation of Patent Grant Mailed Critical | 07 Aug, 2012 | US8236345 |
| Issue Notification Mailed Critical | 18 Jul, 2012 | US8236345 |
| Dispatch to FDC | 06 Jul, 2012 | US8236345 |
| Application Is Considered Ready for Issue Critical | 06 Jul, 2012 | US8236345 |
| Issue Fee Payment Received Critical | 05 Jul, 2012 | US8236345 |
| Issue Fee Payment Verified Critical | 05 Jul, 2012 | US8236345 |
| Expire Patent Critical | 14 May, 2012 | US7358366 |
US patents provide insights into the exclusivity only within the United States, but Avandamet 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 Avandamet's family patents as well as insights into ongoing legal events on those patents.
Avandamet's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Avandamet's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 07, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Avandamet Generic API suppliers:
Metformin Hydrochloride; Rosiglitazone Maleate is the generic name for the brand Avandamet. 1 company has already filed for the generic of Avandamet. Check out the entire list of companies who have already received approval for Avandamet's generic
How can I launch a generic of Avandamet before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Avandamet's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Avandamet'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 Avandamet -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg | 22 Oct, 2004 | 1 | 11 Feb, 2017 | Eligible |
Alternative Brands for Avandamet
Avandamet which is used for managing and treating type 2 diabetes mellitus., has several other brand drugs in the same treatment category . 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab |
| |||||||||
| Boehringer Ingelheim |
| |||||||||
| Cosette |
| |||||||||
| Janssen Pharms |
| |||||||||
About Avandamet
Avandamet is a drug owned by Sb Pharmco Puerto Rico Inc. It is used for managing and treating type 2 diabetes mellitus. Avandamet uses Metformin Hydrochloride; Rosiglitazone Maleate as an active ingredient. Avandamet was launched by Sb Pharmco in 2003.
Approval Date:
Avandamet was approved by FDA for market use on 25 August, 2003.
Active Ingredient:
Avandamet uses Metformin Hydrochloride; Rosiglitazone Maleate as the active ingredient. Check out other Drugs and Companies using Metformin Hydrochloride; Rosiglitazone Maleate ingredient
Treatment:
Avandamet is used for managing and treating type 2 diabetes mellitus.
Dosage:
Avandamet is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |