Ertugliflozin Patent Expiration
Ertugliflozin is used for improving glycemic control in adults with type 2 diabetes. It was first introduced by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc
Ertugliflozin Patents
Given below is the list of patents protecting Ertugliflozin, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Steglatro | US8080580 | Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives | Jul 13, 2030 | Msd Sub Merck |
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 Ertugliflozin's patents.
Latest Legal Activities on Ertugliflozin's Patents
Given below is the list recent legal activities going on the following patents of Ertugliflozin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 27 Jun, 2024 | US8080580 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2023 | US8080580 |
| Second letter to regulating agency to determine regulatory review period | 22 Apr, 2021 | US8080580 |
| Second letter to regulating agency to determine regulatory review period | 15 Apr, 2021 | US8080580 |
| Letter from FDA or Dept of Agriculture re PTE application | 12 Jun, 2019 | US8080580 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 May, 2019 | US8080580 |
| Initial letter Re: PTE Application to regulating agency | 15 Oct, 2018 | US8080580 |
| Patent Term Extension Application under 35 USC 156 Filed | 15 Feb, 2018 | US8080580 |
| Recordation of Patent Grant Mailed Critical | 20 Dec, 2011 | US8080580 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Dec, 2011 | US8080580 |
Ertugliflozin's Family Patents
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Ertugliflozin Generic API Manufacturers
Several generic applications have been filed for Ertugliflozin. The first generic version for Ertugliflozin was by Aurobindo Pharma Ltd and was approved on Jul 13, 2023. And the latest generic version is by Hetero Labs Ltd Unit V and was approved on Sep 17, 2024.
Given below is the list of companies who have filed for Ertugliflozin generic, along with the locations of their manufacturing plants worldwide.
1. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Ertugliflozin. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Discontinued | ORAL | N/A | Jul 13, 2023 |
| 15MG | tablet | Discontinued | ORAL | N/A | Jul 13, 2023 |
Manufacturing Plant Locations New
Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
2. HETERO LABS LTD V
Hetero Labs Ltd Unit V has filed for 2 different strengths of generic version for Ertugliflozin. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Sep 17, 2024 |
| 15MG | tablet | Prescription | ORAL | AB | Sep 17, 2024 |