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Last Updated: February 29, 2024

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 four branded drugs marketed by Aurobindo Pharma Ltd and Msd Sub Merck, and is included in four NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ertugliflozin has sixty patent family members in forty-nine countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ertugliflozin
Recent Clinical Trials for ertugliflozin

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

SponsorPhase
Getz PharmaPhase 4
Case Western Reserve UniversityPhase 4
Yale UniversityPhase 4

See all ertugliflozin clinical trials

Generic filers with tentative approvals for ERTUGLIFLOZIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial5MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial15MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msd Sub Merck STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Costa Rica 20110077 DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL ⤷  Try a Trial
European Patent Office 2334687 DÉRIVÉS DE DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL (DIOXA-BICYCLO[3.2.1.]OCTANE-2,3,4-TRIOL DERIVATIVES) ⤷  Try a Trial
Colombia 6341636 DERIVADOS DE DIOXA-BICICLO[3.2.1]OCTANO-2,3,4-TRIOL ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ertugliflozin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2334687 SPC/GB18/026 United Kingdom ⤷  Try a Trial 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 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 18C1036 France ⤷  Try a Trial PRODUCT NAME: ERTUGLIFLOZINE,OPTIONNELLEMENT SOUS FORME CRISTALLINE,EN PARTICULIER EN TANT QUE CO-CRISTAL AVEC L'ACIDE L-PYROGLUTANIQUE,ET PARTICULIEREMENT ERTUGLIFOZINE ACIDE L-PYROGLUTANIQUE.; REGISTRATION NO/DATE: EU/1/18/1267 20180323
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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