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Last Updated: December 5, 2020

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STEGLATRO Drug Profile

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When do Steglatro patents expire, and when can generic versions of Steglatro launch?

Steglatro is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug.

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

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

US ANDA Litigation and Generic Entry Outlook for Steglatro

Steglatro will be eligible for patent challenges on December 19, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 13, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for STEGLATRO
Drug patent expirations by year for STEGLATRO
Drug Prices for STEGLATRO

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Generic Entry Opportunity Date for STEGLATRO
Generic Entry Date for STEGLATRO*:
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 Clinical Trials for STEGLATRO

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

SponsorPhase
Medical University InnsbruckPhase 3
Elisabethinen HospitalPhase 3
Wilhelminenspital ViennaPhase 3

See all STEGLATRO clinical trials

US Patents and Regulatory Information for STEGLATRO

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 STEGLATRO ertugliflozin TABLET;ORAL 209803-001 Dec 19, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme STEGLATRO ertugliflozin TABLET;ORAL 209803-002 Dec 19, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme STEGLATRO ertugliflozin TABLET;ORAL 209803-001 Dec 19, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for STEGLATRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2334687 2018C/027 Belgium   Start Trial 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   Start Trial 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 CR 2018 00025 Denmark   Start Trial 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:

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