Duetact is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 7 US drug patents filed in 2013. Out of these, 2 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 08, 2028. Details of Duetact'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). | |||
| US8071130 | Solid preparation |
Jun, 2028
(3 years from now) | Active |
| US7700128 | Solid preparation comprising an insulin sensitizer, an insulin secretagogue and a polyoxyethylene sorbitan fatty acid ester |
Jan, 2027
(2 years from now) | Active |
| US6303640 | Pharmaceutical composition |
Aug, 2016
(8 years ago) |
Expired
|
| US6211205 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US7538125 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6150383 | Pharmaceutical composition |
Jun, 2016
(8 years ago) |
Expired
|
| US6329404 | Pharmaceutical composition |
Jun, 2016
(8 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 Duetact's patents.
Latest Legal Activities on Duetact's Patents
Given below is the list of recent legal activities going on the following patents of Duetact.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 May, 2023 | US8071130 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Oct, 2021 | US7700128 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 May, 2019 | US8071130 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Oct, 2017 | US7700128 |
| Expire Patent Critical | 23 Jun, 2017 | US7538125 |
| Recordation of Patent Grant Mailed Critical | 06 Dec, 2011 | US8071130 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Dec, 2011 | US8071130 |
| Issue Notification Mailed Critical | 16 Nov, 2011 | US8071130 |
| Dispatch to FDC | 02 Nov, 2011 | US8071130 |
| Application Is Considered Ready for Issue Critical | 31 Oct, 2011 | US8071130 |
US patents provide insights into the exclusivity only within the United States, but Duetact 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 Duetact's family patents as well as insights into ongoing legal events on those patents.
Duetact's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Duetact's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 08, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Duetact Generic API suppliers:
Glimepiride; Pioglitazone Hydrochloride is the generic name for the brand Duetact. 1 company has already filed for the generic of Duetact. Check out the entire list of companies who have already received approval for Duetact's generic
How can I launch a generic of Duetact before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Duetact's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Duetact'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 Duetact -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 30 mg/2 mg and 30 mg/4 mg | 22 Dec, 2009 | 1 | 04 Jan, 2013 | 08 Jun, 2028 | Deferred |
Alternative Brands for Duetact
Duetact which is used for improving glycemic control in patients with type 2 diabetes., 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 | ||
|---|---|---|---|---|
| Takeda Pharms Usa |
| |||
About Duetact
Duetact is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for improving glycemic control in patients with type 2 diabetes. Duetact uses Glimepiride; Pioglitazone Hydrochloride as an active ingredient. Duetact was launched by Takeda Pharms Usa in 2006.
Approval Date:
Duetact was approved by FDA for market use on 28 July, 2006.
Active Ingredient:
Duetact uses Glimepiride; Pioglitazone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Glimepiride; Pioglitazone Hydrochloride ingredient
Treatment:
Duetact is used for improving glycemic control in patients with type 2 diabetes.
Dosage:
Duetact is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG;30MG | TABLET | Prescription | ORAL |
| 4MG;30MG | TABLET | Prescription | ORAL |