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
(7 years ago) |
Expired
|
| US6475521 | Biphasic controlled release delivery system for high solubility pharmaceuticals and method |
Mar, 2018
(7 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.
Latest 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 Issue Date Used in PTA Calculation
Critical | 09 Dec, 2003 | US6660300 |
| Recordation of Patent Grant Mailed
Critical | 09 Dec, 2003 | US6660300 |
| Issue Notification Mailed
Critical | 20 Nov, 2003 | US6660300 |
| Receipt into Pubs | 05 Nov, 2003 | US6660300 |
| Application Is Considered Ready for Issue
Critical | 03 Nov, 2003 | US6660300 |
| Issue Fee Payment Received
Critical | 09 Oct, 2003 | US6660300 |
| Issue Fee Payment Verified
Critical | 09 Oct, 2003 | US6660300 |
| Receipt into Pubs | 25 Jul, 2003 | US6660300 |
| Dispatch to Publications | 24 Jul, 2003 | US6660300 |
| Notice of Allowance Data Verification Completed
Critical | 14 Jul, 2003 | US6660300 |
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
Explore Our Curated Drug Screens
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. 70 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.
| Drug Owner | Drug Name | |||||
|---|---|---|---|---|---|---|
| Andrx Labs Llc |
| |||||
| Astrazeneca Ab |
| |||||
| Boehringer Ingelheim |
| |||||
| Bristol Myers Squibb |
| |||||
| Janssen Pharms |
| |||||
| Msd Sub Merck |
| |||||
| Novo Nordisk Inc |
| |||||
| Ranbaxy |
| |||||
| Santarus Inc |
| |||||
| Sb Pharmco |
| |||||
| Sun Pharm |
| |||||
| Takeda Pharms Usa |
|
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 |