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Last Updated: December 6, 2022

Ertugliflozin - Generic Drug Details


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What are the generic drug sources for ertugliflozin and what is the scope of patent protection?

Ertugliflozin is the generic ingredient in three branded drugs marketed by Msd Sub Merck and is included in three NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ertugliflozin has fifty-nine patent family members in forty-eight countries.

Two suppliers are listed for this compound.

Summary for ertugliflozin
Recent Clinical Trials for ertugliflozin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Icahn School of Medicine at Mount SinaiPhase 4
Medical University of ViennaPhase 3
Klinikum Klagenfurt am WörtherseePhase 3

See all ertugliflozin clinical trials

Paragraph IV (Patent) Challenges for ERTUGLIFLOZIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
STEGLATRO Tablets ertugliflozin 5 mg and 15 mg 209803 3 2021-12-20

US Patents and Regulatory Information for ertugliflozin

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 209806-004 Dec 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-004 Dec 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Msd Sub Merck SEGLUROMET ertugliflozin; metformin hydrochloride TABLET;ORAL 209806-004 Dec 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Merck Sharp & Dohme B.V. Steglatro ertugliflozin EMEA/H/C/004315
Steglatro 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:, , , as monotherapy in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications., in addition to other medicinal products for the treatment of diabetes., ,
Authorised no no no 2018-03-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ertugliflozin

Country Patent Number Title Estimated Expiration
Cuba 20110041 DERIVADOS DE DIOXA-BICICLO(3.2.1)OCTANO-2,3,4-TRIOL See Plans and Pricing
Colombia 6341636 DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL See Plans and Pricing
Peru 20110288 DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL See Plans and Pricing
Hong Kong 1156616 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-) See Plans and Pricing
South Korea 101446454 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ertugliflozin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2334687 392 18-2018 Slovakia See Plans and Pricing PRODUCT NAME: ERTUGLIFLOZIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1267 20180323
2334687 2018C/027 Belgium See Plans and Pricing 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 LUC00079 Luxembourg See Plans and Pricing PRODUCT NAME: ERTUGLIFLOZINE, EVENTUELLEMENT SOUS FORME CRISTALLINE, EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTAMIQUE, ET PLUS SPECIFIQUEMENT EN TANT QU'ACIDE ERTUGLIFLOZINE L-PYROGLUTAMIQUE; AUTHORISATION NUMBER AND DATE: EU/1/18/1267 20180323
2334687 SPC/GB18/026 United Kingdom See Plans and Pricing 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 CR 2018 00025 Denmark See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
McKinsey
Harvard Business School
Boehringer Ingelheim
Medtronic

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