Fortamet is a drug owned by Andrx Labs Llc. It is protected by 6 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 17, 2021. Details of Fortamet'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). | |||
| US6866866 | Controlled release metformin compositions |
Mar, 2021
(3 years ago) |
Expired
|
| US6790459 | Methods for treating diabetes via administration of controlled release metformin |
Mar, 2021
(3 years ago) |
Expired
|
| US8475841 | Controlled release metformin formulations |
Mar, 2018
(6 years ago) |
Expired
|
| US6099859 | Controlled release oral tablet having a unitary core |
Mar, 2018
(6 years ago) |
Expired
|
| US6495162 | Controlled release oral tablet having a unitary core |
Mar, 2018
(6 years ago) |
Expired
|
| US7919116 | Controlled release metformin formulations |
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 Fortamet's patents.
Latest Legal Activities on Fortamet's Patents
Given below is the list of recent legal activities going on the following patents of Fortamet.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 08 May, 2023 | US7919116 |
| Maintenance Fee Reminder Mailed Critical | 21 Nov, 2022 | US7919116 |
| Expire Patent Critical | 09 Aug, 2021 | US8475841 |
| Maintenance Fee Reminder Mailed Critical | 22 Feb, 2021 | US8475841 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Sep, 2018 | US7919116 |
| File Marked Found | 09 Nov, 2016 | US6495162 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Jul, 2013 | US8475841 |
| Recordation of Patent Grant Mailed Critical | 02 Jul, 2013 | US8475841 |
| Issue Notification Mailed Critical | 12 Jun, 2013 | US8475841 |
| Dispatch to FDC | 07 Jun, 2013 | US8475841 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Fortamet and ongoing litigations to help you estimate the early arrival of Fortamet generic.
Fortamet's Litigations
Fortamet been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 23, 2017, against patent number US6790459. The petitioner Aurobindo Pharma USA Inc., challenged the validity of this patent, with Andrx Labs, LLC as the respondent. Click below to track the latest information on how companies are challenging Fortamet's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6866866 | June, 2017 |
FWD Entered
(28 Dec, 2018) | Andrx Labs, LLC | Aurobindo Pharma USA Inc. |
| US6790459 | January, 2018 |
Terminated-Denied
(05 Sep, 2018) | Andrx Labs, LLC | Aurobindo Pharma USA Inc. |
| US6790459 | June, 2017 |
Terminated-Denied
(29 Dec, 2017) | Andrx Labs, LLC | Aurobindo Pharma USA Inc. |
US patents provide insights into the exclusivity only within the United States, but Fortamet 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 Fortamet's family patents as well as insights into ongoing legal events on those patents.
Fortamet's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fortamet's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 17, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fortamet Generic API suppliers:
Metformin Hydrochloride is the generic name for the brand Fortamet. 67 different companies have already filed for the generic of Fortamet, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fortamet's generic
How can I launch a generic of Fortamet before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fortamet's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fortamet'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 Fortamet -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 500 mg and 1000 mg | 14 Oct, 2008 | 1 | 29 Jun, 2011 | 17 Mar, 2021 | Extinguished Eligible |
Alternative Brands for Fortamet
Fortamet which is used for managing and controlling blood glucose levels., 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 | |||||
|---|---|---|---|---|---|---|
| Astrazeneca Ab |
| |||||
| Boehringer Ingelheim |
| |||||
| Bristol Myers Squibb |
| |||||
| Emd Serono Inc |
| |||||
| 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, Fortamet's active ingredient. Check the complete list of approved generic manufacturers for Fortamet
About Fortamet
Fortamet is a drug owned by Andrx Labs Llc. It is used for managing and controlling blood glucose levels. Fortamet uses Metformin Hydrochloride as an active ingredient. Fortamet was launched by Andrx Labs Llc in 2004.
Approval Date:
Fortamet was approved by FDA for market use on 27 April, 2004.
Active Ingredient:
Fortamet uses Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Metformin Hydrochloride ingredient
Treatment:
Fortamet is used for managing and controlling blood glucose levels.
Dosage:
Fortamet 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 |
| 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Prescription | ORAL |