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
*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 |
|---|---|
| Merck Sharp & Dohme Corp. | Phase 4 |
| Cedars-Sinai Medical Center | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | SEGLUROMET | ertugliflozin; metformin hydrochloride | TABLET;ORAL | 209806-002 | Dec 19, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Msd Sub Merck | SEGLUROMET | ertugliflozin; metformin hydrochloride | TABLET;ORAL | 209806-004 | Dec 19, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Msd Sub Merck | SEGLUROMET | ertugliflozin; metformin hydrochloride | TABLET;ORAL | 209806-001 | Dec 19, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Msd Sub Merck | SEGLUROMET | ertugliflozin; metformin hydrochloride | TABLET;ORAL | 209806-001 | Dec 19, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Msd Sub Merck | SEGLUROMET | ertugliflozin; metformin hydrochloride | TABLET;ORAL | 209806-001 | Dec 19, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Msd Sub Merck | SEGLUROMET | ertugliflozin; metformin hydrochloride | TABLET;ORAL | 209806-002 | Dec 19, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 |
|---|---|---|---|
| Montenegro | 01285 | DERIVATI DIOKSA-BICIKL0[3.2.1]OKTAN-2,3,4-TRIOLA (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES) | ⤷ Sign Up |
| Argentina | 073138 | DERIVADOS DE DIOXA-BICICLO (3.2.1) OCTANO- 2,3,4-TRIOL | ⤷ Sign Up |
| France | 18C1036 | ⤷ Sign Up | |
| Australia | 2010310956 | Dioxa-bicyclo[3.2.1]octane-2,3,4-triol derivatives | ⤷ Sign Up |
| Panama | 8840801 | DERIVAOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2011051864 | ⤷ Sign Up | |
| >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 | 300943 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZINE, DESGEWENST IN KRISTALVORM, MET NAME ALS CO-KRISTAL MET L-PYROGLUTAMINEZUUR, MET NAME ERTUGLIFLOZIN L-PYROGLUTAMINE ZUUR; REGISTRATION NO/DATE: EU/1/18/1267 20180323 |
| 2334687 | CR 2018 00025 | Denmark | ⤷ Sign Up | 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 | SPC/GB18/026 | United Kingdom | ⤷ Sign Up | 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 |
| 2334687 | 30/2018 | Austria | ⤷ Sign Up | 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 | PA2018510 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ERTUGLIFLOZINAS, PASIRINKTINAI KAIP KRISTALINE FORMA, YPAC KAIP KO-KRISTALAS SU L-PIROGLUTAMO RUGSTIMI, IR YPAC KAIP ERTUGLIFLOZINO L-PIROGLUTAMO RUGSTIS; REGISTRATION NO/DATE: EU/1/18/1267 20180321 |
| 2334687 | 716 | Finland | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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