Segluromet Patent Expiration

Segluromet is a drug owned by Merck Sharp And Dohme Llc A Sub Of Merck And Co Inc. It is protected by 3 US drug patents filed in 2018 out of which none have expired yet. Segluromet'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 Oct 21, 2030. Details of Segluromet'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
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9308204 Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Oct, 2030

(6 years from now)

Active
US9439902 Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Oct, 2030

(6 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 Segluromet's patents.

Given below is the list of recent legal activities going on the following patents of Segluromet.

Activity Date Patent Number
Patent litigations
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 20 Dec, 2011 US8080580
Patent Issue Date Used in PTA Calculation 20 Dec, 2011 US8080580


FDA has granted several exclusivities to Segluromet. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Segluromet, 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 Segluromet.

Exclusivity Information

Segluromet holds 2 exclusivities. All of its exclusivities have expired in 2024. Details of Segluromet'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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Segluromet 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 Segluromet's family patents as well as insights into ongoing legal events on those patents.

Segluromet's Family Patents

Segluromet has patent protection in a total of 49 countries. It's US patent count contributes only to 14.8% of its total global patent coverage. 10 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Segluromet.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Segluromet's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 21, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Segluromet Generics:

There are no approved generic versions for Segluromet as of now.

Alternative Brands for Segluromet

Segluromet which is used for improving glycemic control in adults 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
Msd Sub Merck
Steglatro used for improving glycemic control in adults with type 2 diabetes.
Steglujan used for improving glycemic control in adults with type 2 diabetes.
Theracosbio
Brenzavvy Used for improving glycemic control in adults with type 2 diabetes.





About Segluromet

Segluromet 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. Segluromet uses Ertugliflozin; Metformin Hydrochloride as an active ingredient. Segluromet was launched by Msd Sub Merck in 2017.

Approval Date:

Segluromet 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 Segluromet is 19 December, 2017, its NCE-1 date is estimated to be 19 December, 2021.

Active Ingredient:

Segluromet uses Ertugliflozin; Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Ertugliflozin; Metformin Hydrochloride ingredient

Treatment:

Segluromet is used for improving glycemic control in adults with type 2 diabetes.

Dosage:

Segluromet is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
7.5MG;1GM TABLET Prescription ORAL
7.5MG;500MG TABLET Prescription ORAL
2.5MG;1GM TABLET Prescription ORAL
2.5MG;500MG TABLET Prescription ORAL