SEGLUROMET Drug Patent Profile
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Which patents cover Segluromet, and what generic alternatives are available?
Segluromet is a drug marketed by Msd Sub Merck and is included in one NDA. There are three patents protecting this drug.
This drug has eighty-five patent family members in forty-eight countries.
The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. Two suppliers are listed for this compound. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Segluromet
Segluromet was eligible for patent challenges on December 19, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 21, 2030. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for SEGLUROMET
International Patents: | 85 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SEGLUROMET |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SEGLUROMET |
What excipients (inactive ingredients) are in SEGLUROMET? | SEGLUROMET excipients list |
DailyMed Link: | SEGLUROMET at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SEGLUROMET
Generic Entry Date for SEGLUROMET*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for SEGLUROMET
Drug Class | Biguanide |
Anatomical Therapeutic Chemical (ATC) Classes for SEGLUROMET
US Patents and Regulatory Information for SEGLUROMET
SEGLUROMET is protected by three US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SEGLUROMET is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SEGLUROMET
Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
FDA Regulatory Exclusivity protecting SEGLUROMET
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY, MK-8835-004/B1521021, VERTIS CV
Exclusivity Expiration: ⤷ Try a Trial
EU/EMA Drug Approvals for SEGLUROMET
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Merck Sharp & Dohme B.V. | Segluromet | ertugliflozin, metformin hydrochloride | EMEA/H/C/004314 Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:, , , in patients not adequately controlled on their maximally tolerated dose of metformin alone, in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes, in patients already being treated with the combination of ertugliflozin and metformin as separate tablets., , |
Authorised | no | no | no | 2018-03-23 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for SEGLUROMET
When does loss-of-exclusivity occur for SEGLUROMET?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
African Regional IP Organization (ARIPO)
Patent: 99
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 10310956
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 77857
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 120289
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0150107
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 15949
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 96583
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 12011946
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1983
Estimated Expiration: ⤷ Try a Trial
Patent: 1290267
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 96583
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0146104
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 96156
Estimated Expiration: ⤷ Try a Trial
Patent: 13509393
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 016
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9945
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 96583
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 96583
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 827
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 96583
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1203486
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1426180
Estimated Expiration: ⤷ Try a Trial
Patent: 120093321
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 27179
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 3416
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering SEGLUROMET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1193606 | 二氧雜-雙環 辛烷- -三醇衍生物 (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES -[321]-234-) | ⤷ Try a Trial |
Japan | 2012500842 | ⤷ Try a Trial | |
Chile | 2011000394 | Compuestos derivados de 1-hidroximetil-6,8-dioxa-biciclo[3.2.1]octano-2,3,4-triol, inhibidores de sglt2; cocristal que comprende a dicho compuesto y l-prolina o acido l-piroglutamico; composicion farmaceutica que los comprende; utiles para el tratamiento de la obesidad y diabetes de tipo 2. | ⤷ Try a Trial |
Cuba | 24003 | DERIVADOS DE DIOXA-BICICLO(3.2.1)OCTANO-2,3,4-TRIOL | ⤷ Try a Trial |
South Korea | 20110045093 | ⤷ Try a Trial | |
Colombia | 6341636 | DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL | ⤷ Try a Trial |
Australia | 2009286380 | Dioxa-bicyclo(3.2.1.)octane-2,3,4-triol derivatives | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SEGLUROMET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2334687 | CR 2018 00025 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ERTUGLIFLOZIN, EVENTUELT SOM EN KRYSTALFORM, SAERLIGT SOM ET CO-KRYSTAL MED L-PYROGLUTAMINSYRE OG SPECIFIKT SOM ERTUGLIFLOZIN-L-PYROGLUTAMINSYRE; NAT. REG. NO/DATE: EU/1/18/1267/001-012 20180323; FIRST REG. NO/DATE: EU EU/1/18/1267/001/012 20180323 |
2334687 | 1890026-6 | Sweden | ⤷ Try a Trial | PRODUCT NAME: ERTUGLIFLOZIN,OPTIONALLY IN THE FORM OF ERTUGLIFOZIN L- PYROGLUTAMIC ACID; REG. NO/DATE: EU/1/18/1267 20180323 |
2334687 | 392 18-2018 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: ERTUGLIFLOZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1267 20180323 |
2334687 | 2018C/027 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, EN SPECIFIEK ALS ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323 |
2334687 | 716 | Finland | ⤷ Try a Trial | |
2334687 | 132018000000441 | Italy | ⤷ Try a Trial | PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323 |
2334687 | C20180023 00266 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ERTUGLIFLOSIIN;REG NO/DATE: EU/1/18/1267 23.03.2018 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |