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Last Updated: October 14, 2019

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STEGLUJAN Drug Profile

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Which patents cover Steglujan, and when can generic versions of Steglujan launch?

Steglujan is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are eight patents protecting this drug.

This drug has two hundred and twenty-three patent family members in fifty-three countries.

The generic ingredient in STEGLUJAN is ertugliflozin; sitagliptin phosphate. One supplier is listed for this compound. Additional details are available on the ertugliflozin; sitagliptin phosphate profile page.

Drug patent expirations by year for STEGLUJAN
Drug Prices for STEGLUJAN

See drug prices for STEGLUJAN

Generic Entry Opportunity Date for STEGLUJAN
Generic Entry Date for STEGLUJAN*:
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.

Recent Litigation for STEGLUJAN

Identify potential future generic entrants

District Court Litigation
Case NameDate
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.2019-05-02
Merck Sharp & Dohme Corp. v. Sandoz Inc.2019-02-13
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.2019-02-13

See all STEGLUJAN litigation

US Patents and Regulatory Information for STEGLUJAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No   See Pricing   See Pricing   See Pricing
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017 RX Yes Yes   See Pricing   See Pricing   See Pricing
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No   See Pricing   See Pricing   See Pricing
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017 RX Yes No   See Pricing   See Pricing Y Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for STEGLUJAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017   See Pricing   See Pricing
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-001 Dec 19, 2017   See Pricing   See Pricing
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017   See Pricing   See Pricing
Merck Sharp Dohme STEGLUJAN ertugliflozin; sitagliptin phosphate TABLET;ORAL 209805-002 Dec 19, 2017   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for STEGLUJAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 300287 Netherlands   See Pricing 300287, 20220705, EXPIRES: 20220320
2334687 C201830047 Spain   See Pricing 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 300943 Netherlands   See Pricing 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
1412357 343 Finland   See Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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