Glucophage Xr Patent Expiration

Glucophage Xr is a drug owned by Emd Serono Inc. It is protected by 2 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 Mar 19, 2018. Details of Glucophage 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).
US6660300 Method of use of a biphasic controlled release delivery system for high solubility pharmaceuticals and method
Mar, 2018

(6 years ago)

Expired
US6475521 Biphasic controlled release delivery system for high solubility pharmaceuticals and method
Mar, 2018

(6 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 Glucophage Xr's patents.

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

Activity Date Patent Number
Patent litigations
Patent Issue Date Used in PTA Calculation 09 Dec, 2003 US6660300
Recordation of Patent Grant Mailed 09 Dec, 2003 US6660300
Issue Notification Mailed 20 Nov, 2003 US6660300
Receipt into Pubs 05 Nov, 2003 US6660300
Application Is Considered Ready for Issue 03 Nov, 2003 US6660300
Issue Fee Payment Received 09 Oct, 2003 US6660300
Issue Fee Payment Verified 09 Oct, 2003 US6660300
Receipt into Pubs 25 Jul, 2003 US6660300
Dispatch to Publications 24 Jul, 2003 US6660300
Notice of Allowance Data Verification Completed 14 Jul, 2003 US6660300

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US patents provide insights into the exclusivity only within the United States, but Glucophage 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 Glucophage Xr's family patents as well as insights into ongoing legal events on those patents.

Glucophage Xr's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Glucophage Xr's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 19, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Glucophage Xr Generic API suppliers:

Metformin Hydrochloride is the generic name for the brand Glucophage Xr. 68 different companies have already filed for the generic of Glucophage Xr, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Glucophage Xr's generic

How can I launch a generic of Glucophage Xr before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Glucophage Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Glucophage 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 Glucophage Xr -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
500 mg
750 mg

Alternative Brands for Glucophage Xr

Glucophage Xr which is used for managing type 2 diabetes through once daily administration., has several other brand drugs using the same active ingredient (Metformin Hydrochloride). 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 Metformin Hydrochloride, Glucophage Xr's active ingredient. Check the complete list of approved generic manufacturers for Glucophage Xr





About Glucophage Xr

Glucophage Xr is a drug owned by Emd Serono Inc. It is used for managing type 2 diabetes through once daily administration. Glucophage Xr uses Metformin Hydrochloride as an active ingredient. Glucophage Xr was launched by Emd Serono Inc in 2000.

Approval Date:

Glucophage Xr was approved by FDA for market use on 13 October, 2000.

Active Ingredient:

Glucophage Xr uses Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Metformin Hydrochloride ingredient

Treatment:

Glucophage Xr is used for managing type 2 diabetes through once daily administration.

Dosage:

Glucophage Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE Discontinued ORAL
750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET, EXTENDED RELEASE Discontinued ORAL