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Last Updated: January 26, 2020

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STEGLATRO Drug Profile

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Which patents cover Steglatro, 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-eight patent family members in forty-seven 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

See drug prices for STEGLATRO

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
VU University Medical CenterPhase 4
MSD Korea Ltd.Phase 3
Soo LimPhase 3

See all STEGLATRO clinical trials

Synonyms for STEGLATRO
(1S,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol
(1S,2S,3S,4R,5S)-5-(4-Chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol
(1S,2S,3S,4R,5S)-5-[4-Chloro-3-(4-ethoxy-benzyl)-phenyl]-1-hydroxymethyl-6,8-dioxa-bicyclo[3.2.1]octane-2,3,4-triol
(1S,2S,3S,4R,5S)-5-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-1-(hydroxymethyl)-6,8-dioxa-bicyclo[3.2.1]octane-2,3,4-triol
(1S,2S,3S,4R,5S)-5-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol
(1S,5S)-1-(Hydroxymethyl)-5-[3-(4-ethoxybenzyl)-4-chlorophenyl]-6,8-dioxabicyclo[3.2.1]octane-2beta,3alpha,4beta-triol
1,6-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-5-C-(hydroxymethyl)-beta-L-idopyranose
1210344-57-2
5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-hydroxymethyl-6,8-dioxabicyclo(3.2.1)octane-2,3,4-triol
6C282481IP
ABP000359
AC-29007
AK174928
AKOS025404928
AS-35204
BC638832
BDBM50342885
beta-L-Idopyranose, 1,6-anhydro-1-C-(4-chloro-3-((4-ethoxyphenyl)methyl)phenyl)-5-C-(hydroxymethyl)-
C22H25ClO7
CHEMBL1770248
CS-0976
D10313
DB11827
DTXSID40153120
Ertugliflozin
Ertugliflozin (USAN/INN)
Ertugliflozin [USAN:INN]
EX-A407
FT-0772529
GTPL8376
HY-15461
J-504029
MCIACXAZCBVDEE-CUUWFGFTSA-N
MK-8835
MolPort-027-720-941
PF 04971729
PF 04971729-00
PF-04971729
PF-04971729-00
PF-04971729;Ertugliflozin
PF-04971729/PF04971729/
PF04971729
RL00877
SB11082
SCHEMBL181047
Tube108
UNII-6C282481IP
W-5850
Y0303
ZINC68197809

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
Merck Sharp Dohme STEGLATRO ertugliflozin TABLET;ORAL 209803-002 Dec 19, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   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 C20180023 00266 Estonia   Start Trial PRODUCT NAME: ERTUGLIFLOSIIN;REG NO/DATE: EU/1/18/1267 23.03.2018
2334687 C201830047 Spain   Start Trial 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 30/2018 Austria   Start Trial 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Merck
Moodys
Colorcon
McKinsey
Harvard Business School

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 verifification 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.