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SEGLUROMET Drug Profile
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Which patents cover Segluromet, and what generic alternatives are available?
Segluromet is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this drug.
This drug has eighty-four patent family members in forty-eight countries.
The generic ingredient in SEGLUROMET is ertugliflozin; metformin hydrochloride. Additional details are available on the ertugliflozin; metformin hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Segluromet
Segluromet will be eligible for patent challenges on December 19, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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.
Indicators of Generic Entry
Summary for SEGLUROMET
International Patents: | 84 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SEGLUROMET |
DailyMed Link: | SEGLUROMET at DailyMed |


Generic Entry Opportunity 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.
US Patents and Regulatory Information for SEGLUROMET
International Patents for SEGLUROMET
Country | Patent Number | Estimated Expiration |
---|---|---|
Cuba | 24003 | Start Trial |
Eurasian Patent Organization | 201290267 | Start Trial |
China | 102149717 | Start Trial |
Nicaragua | 201100043 | Start Trial |
Ukraine | 103416 | Start Trial |
Norway | 2018019 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SEGLUROMET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2334687 | 1890026-6 | Sweden | Start Trial | PRODUCT NAME: ERTUGLIFLOZIN,OPTIONALLY IN THE FORM OF ERTUGLIFOZIN L- PYROGLUTAMIC ACID; REG. NO/DATE: EU/1/18/1267 20180323 |
2334687 | C201830047 | Spain | Start Trial | PRODUCT NAME: ERTUGLIFLOZINA, OPICIONALMENTE EN FORMA CRISTALINA, PARTICULARMENTE COMO UN CO-CRISTAL CON ACIDO L-PIROGLUTAMICO, Y ESPECIFICAMENTE COMO ACIDO L-PIROGLUTAMICO DE ERTUGLIFLOZINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1267; DATE OF AUTHORISATION: 20180321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1267; DATE OF FIRST AUTHORISATION IN EEA: 20180321 |
2334687 | 122018000070 | Germany | Start Trial | PRODUCT NAME: ERTUGLIFLOZIN, EINSCHLIESSLICH KRISTALL UMFASSEND ERTUGLIFLOZIN UND ERTUGLIFLOZIN UND L-PYROGLUTAMINSAEURE ALS CO-KRISTALL; REGISTRATION NO/DATE: EU/1/18/1267 20180321 |
2334687 | 2018/028 | Ireland | Start Trial | PRODUCT NAME: ERTUGLIFLOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFLOZIN L-PYROGLUTAMIC ACID; REGISTRATION NO/DATE: EU/1/18/1267/001 EU/1/18/1267/012 20180321 |
2334687 | 30/2018 | Austria | Start Trial | PRODUCT NAME: ERTUGLIFLOZIN, GEGEBENENFALLS ALS KRISTALLFORM, INSBESONDERE ALS CO-KRISTALL MIT L-PYROGLUTAMINSAEURE, UND INSBESONDERE ALS ERTUGLIFLOZIN L-PYROGLUTAMINSAEURE; REGISTRATION NO/DATE: EU/1/18/1267 (MITTEILUNG) 20180323 |
2334687 | 2018C/027 | Belgium | Start 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |