Avandamet Patent Expiration

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

(3 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

(8 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.

Given below is the list of recent legal activities going on the following patents of Avandamet.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed 25 Mar, 2024 US8236345
Payment of Maintenance Fee, 8th Year, Large Entity 16 Jan, 2020 US8236345
Patent Issue Date Used in PTA Calculation 07 Aug, 2012 US8236345
Recordation of Patent Grant Mailed 07 Aug, 2012 US8236345
Issue Notification Mailed 18 Jul, 2012 US8236345
Dispatch to FDC 06 Jul, 2012 US8236345
Application Is Considered Ready for Issue 06 Jul, 2012 US8236345
Issue Fee Payment Received 05 Jul, 2012 US8236345
Issue Fee Payment Verified 05 Jul, 2012 US8236345
Expire Patent 14 May, 2012 US7358366

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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

Avandamet has patent protection in a total of 43 countries. It's US patent count contributes only to 3.6% of its total global patent coverage. 42 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Avandamet.

Family Patents

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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 Generics:

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
Qtern Used for the treatment of type 2 diabetes mellitus in patients who have inadequate control with dapagliflozin.
Farxiga used for treating heart failure and type 2 diabetes.
Xigduo Xr used for managing type 2 diabetes mellitus when glycemic control is not achievable with other medications.
Qternmet Xr Used for managing blood sugar levels in individuals with type 2 diabetes mellitus.
Boehringer Ingelheim
Tradjenta Used for treating type 2 diabetes, especially in patients with renal impairment and insufficient glycemic control.
Cosette
Welchol Used for lowering serum glucose levels in adults with type 2 diabetes mellitus and lowering cholesterol levels.
Janssen Pharms
Invokana used for the treatment of type 2 diabetes mellitus and reduction of cardiovascular and kidney-related risks.
Invokamet Used for reducing the risk of kidney disease, cardiovascular events, and treating type 2 diabetes mellitus patients.
Invokamet Xr used for treating type 2 diabetes and reducing the risk of kidney disease, cardiovascular events, and heart failure.





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