Glumetza is a drug owned by Santarus Inc. It is protected by 6 US drug patents filed in 2013. Out of these, 2 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 23, 2025. Details of Glumetza's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US7780987 | Controlled release dosage forms |
Mar, 2025
(7 months from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6635280 | Extending the duration of drug release within the stomach during the fed mode |
Sep, 2016
(7 years ago) |
Expired
|
| US6340475 | Extending the duration of drug release within the stomach during the fed mode |
Sep, 2016
(7 years ago) |
Expired
|
| US6488962 | Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms |
Jun, 2020
(4 years ago) |
Expired
|
| US6723340 | Optimal polymer mixtures for gastric retentive tablets |
Oct, 2021
(2 years ago) |
Expired
|
| US8323692 | Controlled release dosage forms |
Mar, 2025
(7 months from now) | Active |
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 Glumetza's patents.
Latest Legal Activities on Glumetza's Patents
Given below is the list of recent legal activities going on the following patents of Glumetza.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 26 Jan, 2022 | US7780987 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Jun, 2020 | US8323692 |
| Review Certificate Mailed | 26 Jul, 2018 | US6723340 (Litigated) |
| Review Certificate | 09 Jul, 2018 | US6723340 (Litigated) |
| Review Certificate Mailed | 09 Feb, 2018 | US6635280 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Feb, 2018 | US7780987 (Litigated) |
| Review Certificate | 14 Dec, 2017 | US6635280 |
| File Marked Found | 25 Apr, 2016 | US6723340 (Litigated) |
| File Marked Found | 18 Feb, 2016 | US6723340 (Litigated) |
| File Marked Found | 12 Feb, 2016 | US6723340 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Glumetza 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 Glumetza's family patents as well as insights into ongoing legal events on those patents.
Glumetza's family patents
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Generic Launch
Generic Release Date:
Glumetza's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 23, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Glumetza Generics:
Metformin Hydrochloride is the generic name for the brand Glumetza. 66 different companies have already filed for the generic of Glumetza, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Glumetza's generic
How can I launch a generic of Glumetza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Glumetza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Glumetza'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 Glumetza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg and 1000 mg | 27 Jul, 2009 | 1 | 19 Jul, 2013 | Eligible |
About Glumetza
Glumetza is a drug owned by Santarus Inc. It is used for managing Type II diabetes. Glumetza uses Metformin Hydrochloride as an active ingredient. Glumetza was launched by Santarus Inc in 2005.
Market Authorisation Date:
Glumetza was approved by FDA for market use on 03 June, 2005.
Active Ingredient:
Glumetza uses Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Metformin Hydrochloride ingredient
Treatment:
Glumetza is used for managing Type II diabetes.
Dosage:
Glumetza is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |