ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for ertugliflozin; metformin hydrochloride and what is the scope of freedom to operate?
Ertugliflozin; metformin hydrochloride
is the generic ingredient in one branded drug marketed by Msd Sub Merck and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Ertugliflozin; metformin hydrochloride has eighty-six patent family members in forty-nine countries.
One supplier is listed for this compound.
Summary for ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
International Patents: | 86 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 9 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE |
DailyMed Link: | ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
Generic Entry Date for ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
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.
Recent Clinical Trials for ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cedars-Sinai Medical Center | Phase 4 |
Merck Sharp & Dohme Corp. | Phase 4 |
Pfizer | Phase 3 |
See all ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE clinical trials
Pharmacology for ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Class | Biguanide |
Anatomical Therapeutic Chemical (ATC) Classes for ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
US Patents and Regulatory Information for ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
EU/EMA Drug Approvals for ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
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 alonein patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetesin 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 ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 103497199 | Dioxa-bicyclo[3.2.1]octane-2, 3, 4-triol derivatives | ⤷ Subscribe |
South Africa | 201203486 | DIOXA-BICYCLO[3.2.1]OCTANE-2,3,4-TRIOL DERIVATIVES | ⤷ Subscribe |
Japan | 5696156 | ⤷ Subscribe | |
Uruguay | 32073 | DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL | ⤷ Subscribe |
Slovenia | 2334687 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2334687 | C02334687/01 | Switzerland | ⤷ Subscribe | FORMER OWNER: PFIZER INC., US |
2334687 | 2018/028 | Ireland | ⤷ Subscribe | 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 | 2018C/027 | Belgium | ⤷ Subscribe | 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 | 132018000000441 | Italy | ⤷ Subscribe | PRODUCT NAME: ERTUGLIFLOZIN(STEGLATRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1267, 20180323 |
2334687 | SPC/GB18/026 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: ERTUGLIFOZIN, OPTIONALLY AS A CRYSTAL FORM, PARTICULARLY AS A CO-CRYSTAL WITH L-PYROGLUTAMIC ACID, AND SPECIFICALLY AS ERTUGLIFOZIN L-PYROGLUTAMIC ACID; REGISTERED: UK EU/1/18/1267/001(NI) 20180321; UK EU/1/18/1267/002(NI) 20180321; UK EU/1/18/1267/003(NI) 20180321; UK EU/1/18/1267/004(NI) 20180321; UK EU/1/18/1267/005(NI) 20180321; UK EU/1/18/1267/006(NI) 20180321; UK PLGB 53095/0064 20180321; UK PLGB 53095/0065 20180321; UK EU/1/18/1267/007(NI) 20180321; UK EU/1/18/1267/008(NI) 20180321; UK EU/1/18/1267/009(NI) 20180321; UK EU/1/18/1267/010(NI) 20180321; UK EU/1/18/1267/011(NI) 20180321; UK EU/1/18/1267/012(NI) 20180321 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
ERTUGLIFLOZIN; METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental
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