Steglatro is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is protected by 1 US drug patent filed in 2018 out of which none have expired yet. Steglatro's patents have been open to challenges since 19 December, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 13, 2030. Details of Steglatro's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8080580 | Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives |
Jul, 2030
(5 years 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 Steglatro's patents.
Latest Legal Activities on Steglatro's Patents
Given below is the list of recent legal activities going on the following patents of Steglatro.
| 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 |
FDA has granted several exclusivities to Steglatro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Steglatro, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Steglatro.
Exclusivity Information
Steglatro holds 2 exclusivities. All of its exclusivities have expired in 2024. Details of Steglatro's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 19, 2022 |
| M(M-275) | Sep 17, 2024 |
US patents provide insights into the exclusivity only within the United States, but Steglatro 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 Steglatro's family patents as well as insights into ongoing legal events on those patents.
Steglatro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Steglatro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 13, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Steglatro Generic API suppliers:
Ertugliflozin is the generic name for the brand Steglatro. 3 different companies have already filed for the generic of Steglatro, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Steglatro's generic
How can I launch a generic of Steglatro before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Steglatro's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Steglatro'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 Steglatro -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 15 mg | 20 Dec, 2021 | 3 | 13 Jul, 2023 | 13 Jul, 2030 | Eligible |
Alternative Brands for Steglatro
Steglatro which is used for improving glycemic control in adults with type 2 diabetes., has several other brand drugs in the same treatment category and using the same active ingredient (Ertugliflozin). 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 | ||||
|---|---|---|---|---|---|---|
| Msd Sub Merck |
| |||||
| Theracosbio |
| |||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ertugliflozin, Steglatro's active ingredient. Check the complete list of approved generic manufacturers for Steglatro
About Steglatro
Steglatro is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is used for improving glycemic control in adults with type 2 diabetes. Steglatro uses Ertugliflozin as an active ingredient. Steglatro was launched by Msd Sub Merck in 2017.
Approval Date:
Steglatro was approved by FDA for market use on 19 December, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Steglatro is 19 December, 2017, its NCE-1 date is estimated to be 19 December, 2021.
Active Ingredient:
Steglatro uses Ertugliflozin as the active ingredient. Check out other Drugs and Companies using Ertugliflozin ingredient
Treatment:
Steglatro is used for improving glycemic control in adults with type 2 diabetes.
Dosage:
Steglatro is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET | Prescription | ORAL |
| 15MG | TABLET | Prescription | ORAL |